End-to-End Regulatory Compliance and Certification Support
MEDICAL DEVICES
MEDICINAL PRODUCTS
COSMETIC PRODUCTS
WELLNESS DEVICES
FOOD SUPPLMENTS
NEURTACEUITCALS
Medical Device Regulatory Consulting for Global Market Access
Medical Device Global Market Access
Medical device product global market access is dynamic which requires a clear regulatory strategy, right risk classification, and making the right regulatory decisions early and executing them without committing mistakes.
We provide end-to-end market access support for medical devices, IVDs, SaMD, and digital health technologies. Our goal is to help manufacturers navigate complex regulatory frameworks and achieve regulatory approvals efficiently, without rework and unnecessary delays.
- Markets We Support
We have diverse product and global experience, focus to solve complex regulatory challenges. We support companies to register their products in more than 20+ global countries like India (CDSCO), the United States (FDA), the European Union (EU MDR/IVDR), the United Kingdom (UKCA), Africa, Middle East markets (SFDA, UAE, Qatar), New Zealand, ASEAN, and other emerging markets. - Device registration
We help our clients get their products to global market as early, efficiently as possible. We can prepare documents and dossier compile, submit, and manage all your device registrations.
In-Country Representation
Global Regulatory frameworks require any foreign medical device manufacturers to appoint an authorized local representative (AR) or Legal Representative (LR), and nomenclature varies from country to country. This role is not an administrative but it carries defined legal and regulatory responsibilities.
We provide in-country representation services to global clients that meet statutory requirements and support effective regulatory communication throughout their medical devices, IVD, SaMD product lifecycle.
Our goal is help the manufacturer for compliance, accountability, and clear exchange of communications to any regulatory authorities.
Global Regulatory M&A Services
Many Mergers and acquisitions (M&A) in the medical device sector fails when regulatory realities are discovered at a later stage. Regulatory approvals, licenses, clinical obligations, and post-market liabilities directly affect the deal value and integration timelines.
With years of expert knowledge we provide regulatory due diligence support for medical device, IVD, and digital health companies for their upcoming, ongoing M&A. Our role is to identify regulatory risks early, quantify their impact, and support informed deal decisions across the global markets.
- Regulatory Due Diligence
We assess the all existing products and pipeline products for regulatory readiness, compliance status, and latent risks. - Post-Merger support
Regulatory integration is often underestimated and poorly planned. We support our clients for post-merger remediation activities.
Human Factors and Usability Engineering
Human Factors and Usability Engineering documentation provides assurance that a medical device can be used safely and effectively by its intended users under real world conditions. It is a regulatory requirement and forms a major component of submissions to regulatory bodies such as the U.S FDA and under European medical device regulations and many others.
Adequate documentation reflects that use related risks have been systematically identified, evaluated, and controlled. Our Human Factors expert support focuses on practical usability engineering, considering regulatory expectations and applicable standards such as IEC 62366.
- Formative evaluation
Usability testing on medical devices evaluation is an iterative process to ensure improvements in device design and functionalities by evaluating and fixing the usability-related issues during their development. The aim is to enhance user experience and make sure that the device is safe, effective, and user-friendly prior to moving on to the later stages of development or market release. - Summative evaluation
Summative Evaluation is important in the later stages of medical device development. They focus on ensuring usability and performance of the device in real-world conditions to establish whether the device meets the needs of the users and regulatory requirements.
Our Human Factors Documentation Support
- Usability Engineering Plan
Creation of a formal plan that outlines usability goals, specified users, usage environments, testing methodologies, roles, and schedules. This document provides the foundation for all usability-related work and guarantees uniformity at each stage of the product cycle. - Regulatory and Standards Gap Assessment
Review of existing design, risk, and usability documentation against applicable regulatory guidance and international standards. Gaps are clearly identified with specific recommendations to address compliance and usability deficiencies. - Usability Engineering File (UEF)
Comprehensive documentation that encapsulates the usability engineering process and outcomes, serving as evidence of compliance with usability standards and regulatory requirements.
Clinical Trials and Performance Evaluation for Medical Devices
We provide structured support for clinical evidence generation and clinical performance evaluation that aligns with global regulatory expectations for medical devices. Clinical evidence is a regulatory cornerstone for demonstrating that a device is both safe and effective for its intended use throughout its lifecycle.
Our services cover the full spectrum of clinical documentation and strategy, from planning and execution to reporting and maintenance.
A Clinical Evaluation consists of an organized process for collecting, analyzing, and interpreting Clinical Evidence to assess how safe, effective, and clinically Significant a Medical Device is for the Intended Population. Clinical Evaluations are required by EU law (specifically, EU Medical Device Regulation 2017/745) and many other Regulatory Agencies in order to obtain CE Marking or Market Access.
Clinical Evidence is generally made up of information compiled from Published Peer-Reviewed Clinical Studies. The aggregate results of these studies are typically compiled in the form of a summary Document or Chart in order to create Clinical Evaluation Reports. It is important to note that the Clinical Evidence Supporting the Safety, Effectiveness, and Clinical Significance of a Clinical Device must come from Clinical Trials or from Manufacturer’s Experiences with Comparable Devices after they have been Commercially Distributed.
Clinical Evidence Support Services
1. Development of a Clinical Strategy and Planning
Establishing a Clinical Evidence Strategy will allow you to determine what types of Clinical Studies are needed to support the Medical Device, what End Points need to be pursued in those Clinical Trials, and where you will get your Clinical Evidence (Clinical Research Publications, Registries, etc.). Establishing a Clinical Evidence Strategy will also facilitate timely and compliant development of the Clinical Evidence.
We help define the clinical evidence strategy based on device classification, risk profile, and regulatory requirements. This includes determining the appropriate study types, endpoints, and data sources. A clear plan drives efficient and compliant evidence generation.
2. Clinical Trial or Clinical Investigation Support Activities
Medical Devices that require the conduct of Formal Clinical Testing and preparing the Study Protocol, designing the Study, identifying Principal Investigators, initiating Study Sites, and Developing Monitoring Plans.
For devices requiring formal clinical trials, we assist with protocol development, study design, investigator selection, site initiation, and monitoring plan development and execution of trails. Scientific Rigor and Compliance with all Regulatory Obligations are of utmost importance to us.
3. Conducting Systematic Literature Reviews
Conducting Systematic Reviews of Publicly Available Clinical Data is often required to provide Supplementary Clinical Evidence to Support Clinical Evaluation. We utilize thorough search strategies to Review Publicly Available Databases and Assess the Quality of the Evidence contained in the Articles Retrieved through our Searches.
- Systematic Literature Review
A systematic review of publicly available clinical data is often needed to support clinical evaluations. We conduct methodical searches, screen literature against predefined criteria, and appraise the quality of evidence to integrate into your evaluation - Clinical Performance Evaluation
We assess clinical data to confirm that the device performs as intended in real-world use. This includes analytical and clinical performance for diagnostic devices and safety/performance endpoints for therapeutic devices. - Clinical Evaluation Report (CER), Performance Evaluation Report (PER) Preparation
We will draft the Clinical Evaluation Report, Performance Evaluation Report that summarizes all clinical evidence, explains the methodology used, and demonstrates how the data supports safety and performance claims. The CER or PER is a key document for medical devices, IVD devices regulatory submissions. - Post-Market Clinical Follow-Up (PMCF), PMPF
Clinical evidence is not static. We help establish and maintain ongoing clinical performance monitoring plans to capture real-world data after-market launch as per part of regulatory requirements based on product risk class and region, it will be periodically updated. This ensures the clinical evaluation remains current and regulators’ expectations for lifecycle documentation are met.
Biocompatibility
Assessment and Documentation support
Biocompatibility assessment demonstrates that a medical device is safe for contact with the human body under its intended conditions of use. It is a regulatory requirement and a critical component of market approval for devices intended for patient or user contact.
Regulatory authorities, including the U.S. Food and Drug Administration and EU notified bodies, expect a scientifically justified and risk-based biocompatibility evaluation. Our biocompatibility support focuses on regulatory-compliant assessment, clear scientific rationale, and documentation, and testing.
Biocompatibility is not limited to only laboratory testing. It is a structured evaluation of materials, manufacturing processes, and device use characteristics to identify and control potential biological risks. The assessment is performed in accordance with the principles of International Organization for Standardization ISO 10993, and aligned with regulatory guidance.
A robust biocompatibility strategy considers the nature of body contact, contact duration, patient population, and existing material data.
Scope of Biocompatibility Services
- Gap Assessment against ISO 10993 and Regulatory Expectations
- Material and Chemical Characterization Review
- Biological Evaluation Strategy
- Biological Evaluation Plan and Report (BEP & BER)
- Execution of Biocompatibility testing
Medical Devices, IVD, and SaMD Cybersecurity Evaluation
One of the most important safety requirements for software-enabled and networked medical devices is cybersecurity. Many times, issues related to cybersecurity findings create regulatory queries, cause approval delays and create uncertainties about post-market corrective actions.
Regulators expect that manufacturers are controlling cybersecurity risks for the entire lifecycle of the device and not just before its launch. Therefore, if the documentation supporting a specific product’s weak or fragmented cyber security controls increases the regulatory enforcement risk for that product and the manufacturer’s overall claims of the safety of that product as a medical device.
From design and development to post-market surveillance, regulators expect manufacturers to recognize, evaluate, and manage cybersecurity risks at every stage of the device lifecycle. Increasingly, cybersecurity flaws are viewed as patient safety concerns rather than IT issues.
We help our clients for regulation-ready cybersecurity initiatives that meet the requirements of regulatory bodies like the EU’s Medical Device Regulation and the US Food and Drug Administration.
What Cybersecurity in Medical Devices Involves
Protecting the device, data, and clinical function from deliberate and inadvertent threats is the main goal of medical device cybersecurity. This entails protecting availability, confidentiality, integrity, and clinical performance in both favorable and unfavorable circumstances.
Scope of Cybersecurity Services
- Cybersecurity Regulatory Strategy
Defining a cybersecurity compliance strategy according to target markets, device type, connectivity, and intended use is key requirement. Aligning cybersecurity operations with relevant regulatory guidelines and standards are critical for regulatory compliance. - Cybersecurity Risk Assessment and Threat Modeling
Identification and evaluation of cybersecurity hazards, including threat scenarios, vulnerabilities, and potential impacts on patient safety and device performance. We help in identifying Risks and are assessed and documented as part of the overall risk management processes. - Secure Design and Architecture Review
We support in Review of architecture, software design, and system interfaces to assess security controls such as authentication, authorization, encryption, and secure update methods. Early detection of design flaws prevents time, and cost for remediation at a later stage. - Software Bill of Materials (SBOM) Support
SBOMs is primary requirement and many regulatory submissions to FDA were not accepted as this document will support transparency, vulnerability management. We support in preparation and review of SBOMs to document all third-party software components and dependencies. - Verification and Validation Support
Support for cybersecurity verification activities, including security testing strategy, vulnerability assessment planning, and review of test evidence. - Cybersecurity Documentation Support
We Prepare submission-ready cybersecurity documentation which include risk assessments, security architecture descriptions, and lifecycle management plans. - Post-Market Cybersecurity and Vulnerability Management
We support our clients to Establish processes for vulnerability monitoring, incident handling, and security updates. This ensures ongoing compliance and readiness for post-market compliance.
ISO 13485 Quality Management System (QMS) Implementation and Support
The ISO 13485 Quality Management System establishes quality management system (QMS) requirements for manufacturers and service providers of medical devices. When organizations achieve certification to ISO 13485, they demonstrate that they have put in place, followed through with, and continue to follow through with processes that consistently satisfy the requirements of both customers and regulatory agencies throughout the design and manufacture of a medical device.
ISO 13485 is not a template exercise; it involves a structured, process-oriented QMS that includes design control, risk management, supplier control, production and post-market activities. Regulators and certification bodies require evidence that the quality management system has been established and documented, monitored and documented, therefore, a practical implementation of ISO 13485 must ensure compliance with regulatory requirements (FDA QSR) and EU requirements.
QMS Strategy and Scope
Determined at each phase of a project, the Scope of the QMS explains the clauses to be included, the exclusions where justified, and how the QMS is aligned with the organization’s business operations.
We support practical ISO 13485 implementation and maintenance, focused on audit readiness, regulatory alignment, and operational usability rather than document-heavy systems that fail in real audits. Our approach aligns ISO 13485 requirements with applicable regulatory frameworks, including FDA QSR expectations and EU MDR quality system requirements.
- Gap Assessment
Gap assessment of existing processes and documentation against ISO 13485 and QMSR requirements. All gaps are clearly identified with specific, actionable remediation steps - QMS Documentation
We support in development of QMS documentation including quality manual, procedures, SOPs, and records. Documentation will be structured and built to be audit-ready and can be used directly for day to day operations. - Internal Audits and Management Review Support
We help our clients for development of internal audit programs and management review processes that meet ISO 13485 requirements and provide meaningful oversight rather than formal compliance. - Certification and Surveillance Audit Support
We hand hold and guide in preparation for certification and surveillance audits, including mock audits, evidence review, and support during auditor interactions.
Simplifying Regulatory Complexity
for
Med Tech Innovators
Med Tech Company
Regulatory complexity can be overwhelming for Medical devices, In-Vitro Diagnostics, Software as a Medical device (SaMD) Innovators, Importers, and Manufacturers.
Problem
A single misstep in classifying your medical device, or documentation can delay marketentry by months to years. These timelines can affect investor confidence, disrupt commercial launches, and create costly compliance gaps.
we are here to help you navigate every checkpoint
-
Risk
Classification - QMS
- Design
- Prototype
- Testing
-
Clinical
Evaluation -
Dossier
Preparation - Submission
- Licensing
About Us
We provide comprehensive certification, regulatory, and compliance support for medical devices, IVDs, and software as medical devices (SaMD).
From regulatory strategy to post-market surveillance our experts ensure faster approvals across India, China, Indonesia, South Korea, Israel, Singapore, Malaysia, Egypt, Morocco, South Africa, Algeria, Europe, UK, Turkey, Serbia, Saudi Arabia, UAE, USA, Argentina, Brazil, Australia, and New Zealand.
We also support startups and innovators who are new to the regulatory landscape from feasibility assessment and classification strategy to prototype testing and approval.
For established importers, we manage large portfolios, renewal timelines, change notifications, and authority interactions through a dedicated regulatory project manager, with AI solutions.
Regions we support
We support innovation across diverse sectors with tailored compliance and testing solutions.
USFDA
Your Trusted Partner for your Medical devices, IVD devices - 510(k), De Novo, PMA, and SaMD Submissions
- Regulatory Affairs & Regulatory Intelligence
- Regulatory Consulting and Market Access Roadmap
- Registration Pathways and License Management
- Regulatory Submissions
- Artwork & Regulatory Labeling
- Packaging compliance Management
- Medical and Scientific Writing
With the right consulting partner and knowledgeable staff, navigating the US FDA medical device regulatory complex environment doesn’t have to be difficult or time-consuming.
We offer end-to-end FDA regulatory consulting for medical devices, IVDs, and digital health solutions, helping you achieve faster and compliant market entry. Our experts guide you through the entire FDA submission lifecycle, from device classification and testing to clearance, approval, and post-market compliance.
Our expertise includes:
- Determine device classification (Class I, II, or III), or support in Classification request 513 (g)
- Identify appropriate regulatory pathway, 510(k), De Novo, or PMA
- Predicate device analysis and regulatory strategy mapping
- Review and support for preparation of intended use, indications for use, and labeling
- Full preparation and compilation of Traditional, Abbreviated, or Special 510(k)
- Predicate comparison and substantial equivalence justification
- Coordination for bench testing, biocompatibility, software, and EMC requirements
- Interaction with FDA reviewers and response to deficiency letters
- Preparation of De Novo request documentation for novel low/moderate-risk devices
- Risk-benefit assessment, clinical justification, and special control proposals
- End-to-end support through FDA review and classification grant
- Strategic planning and preparation of PMA applications for Class III devices
- Clinical evidence compilation, statistical review, and manufacturing information
- SaMD classification and Pre-Submission (Q-Sub) guidance
- Compliance with FDA’s Digital Health Framework and AI/ML device guidance
- Software validation (IEC 62304), cybersecurity (FDA premarket guidance), and HIPAA alignment
- Support for Clinical Decision Support (CDS) and real-world data strategies
CDSCO
Overview
India is one of key developing market contributing for imports and exports of Medical Device. The Central Drug Standard Control Organization (CDSCO) is a regulatory body which regulates Drugs, Cosmetics, medical devices and In-Vitro Diagnostics (IVD) marketed in India.
All the applications for both Notified and Non-notified devices must be submitted through online portal called SUGAM and the manages the applications through the same portal.
We provide end-to-end CDSCO consulting support for Medical Devices, IVDs, and Software as a Medical Device (SaMD), ensuring your products meet India’s Medical Device Rules (MDR 2017) and Central Drugs Standard Control Organization (CDSCO) requirements from classification to license approval.
Our expert team can help in simplifying complex regulatory pathways, guide you in the design optimal pathway, reduce time to approval, assist you to move from concept to commercialization efficiently and confidently while ensure full compliance with CDSCO requirements.
Our Core Services
- SUGAM account creation and account management
- Liaison with the CDSCO, Central and State Licensing Authorities (CLA and SLA)
- Assessment of device intended use, technology, and global approvals
- Preparation of Classification Request Document (CRD)
- Advisory on applicable CDSCO forms, license types, and timelines
- Medical Device Classification and grouping strategy
- Regulatory Gap Assessment to identify missing data, required documents and compliance risks and provide guidance, suggestions.
- Regulatory Intelligence and Due-Diligence services in India
- Dossiers Preparation and submission for Test license
- Coordination with labs and test facilities, guidance and review support for preclinical and validation documents.
- In-country Testing services
- Execute testing, EMC, Electrical safety as per the standards.
- Review and guide Clinical Investigation Plan (CIP), Investigators Brochure (IB), and informed consent forms (ICF)
- Coordination with Ethics Committee (EC) and CROs clinical trail
- GCP and ISO 14155 documentation support
- Technical file & Device Master File (DMF) compilation
- Risk management, performance data, and safety summary preparation
- Submission, query management, and follow-up with CDSCO
- Complete support for QMS implementation per ISO 13485 or as per Schedule 5 of MDR 2017
- Labeling Compliance to MDR 2017 Labelling requirements
- Preparation of Plant Master File (PMF) and Plant Audit Readiness
- Liaison during CDSCO audit and post-approval compliance
- For global manufacturers seeking India market entry
- Dossier preparation aligned with predicate device or PMA approval data
- Authorized Indian Representative (AIR) services
CE Marking (EU)
Confidently access the European Market.
Why CE Marking
To market medical devices,In Vitro Diagnostics, and Software as a Medicaldevices (SaMD) in theEuropean Union, manufacturers must demonstrate compliance with the EU Medical Device Regulation (EU MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746).
A CE Mark is a proof of safety,performance, and regulatory compliance.
Our expertise includes:
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
China Medical Device Regulatory Services
China is one of the tightly regulated and fastest evolving medical device markets in the world. Approval process is controlled by the National Medical Products Administration (NMPA), with technical review handled by the Center for Medical Device Evaluation (CMDE).
China requires its own documentation structure, and often local evidence and regulatory pathway.
Medical devices, IVD devices in China are classified as Class I, Class II, or Class III, based on risk.
Incorrect classification is one of the most common causes of rejection and delays.
- Class I: Filing with provincial authority
- Class II: Registration with provincial NMPA office
- Class III: Central registration with NMPA (Beijing)
Our team performs classification analysis aligned with CMDE expectations, reducing the risk of rework later in the process.
China mandates a local Legal Agent for all foreign manufacturers.
The AR is legally responsible for following activities
- Product registration and renewals
- Post-market surveillance and adverse event reporting
- Regulatory communication with NMPA
- Product recalls and field actions, communications
Choosing the wrong agent creates long-term regulatory risk. We support agent selection, qualification, contracting, and transitions.
Our focus is simple:
- Expert team & Fewer review rounds
- Right classification and pathway lead to Faster approvals
- Early to the market with Lower regulatory risk
- Long-term compliance, not just initial registration
- Early enter to the market increase your market share
Our Services
- Regulatory Intelligence (RI) support
- In-country testing, including non-clinical and clinical testing
- QMS compliance support
- Compilation of Dossier
- Clinical Evaluation Report (CER) preparation
- Labelling & Translation services support
- Submission and Liaising services with the NMPA
- In-country representation
Indonesia Medical Device Regulatory Overview
Medical devices in Indonesia are regulated by Badan Pengawas Obat dan Makanan (BPOM) under the Ministry of Health framework. Indonesia follows a mandatory pre-market registration system, and no medical device can be imported, distributed, or sold without BPOM approval.
For foreign manufacturers, Indonesia is a local-partner–driven market. Market access depends on correct classification, a compliant local distributor or license holder, and technically solid submissions aligned with Indonesian regulations.
Medical devices are governed by:
Ministry of Health regulations on medical devices and IVDs
BPOM technical guidance and electronic submission requirements
Risk-based classification aligned with ASEAN principles
Indonesia has tightened enforcement in recent years, especially on software devices, labeling accuracy, and post-market controls.
Competent Authority: BPOM
Scope: Medical devices, IVDs, active devices, accessories, and certain medical software
Indonesia requires full device registration prior to commercialization.
Core steps:
Appointment of a licensed Indonesian local license holder
Product classification and grouping
Technical dossier preparation
BPOM electronic submission and review
There is no automatic reliance pathway based on US FDA or CE approval. Reference approvals support the submission but do not replace BPOM review.
Foreign manufacturers cannot register directly. A local Indonesian license holder (often a distributor with appropriate licenses such as IDAK — Izin Distribusi Alat Kesehatan) must hold the marketing authorisation and manage the product in Indonesia
Indonesia applies a four-tier risk classification:
Class, Risk Level
Class A, Low
Class B, Low–Moderate
Class C, Moderate–High
Class D, High
Classification determines documentation depth, clinical evidence expectations, and BPOM review timelines.
ISO 13485 is the accepted standard
Certificates must be valid and cover the submitted device scope
BPOM may request additional clarification for outsourced manufacturing
For higher-risk devices, QMS alignment with the technical file is closely examined.
BPOM typically reviews:
Device description and intended use
Risk management documentation
Performance and safety evidence
Manufacturing and quality controls
Clinical or performance data where applicable
Submissions are dossier-based and uploaded through BPOM’s electronic system.
Bahasa Indonesia is mandatory
Labels and IFUs must match approved indications and configuration
Local license holder details must be displayed
Over-labeling is permitted but must be consistent and controlled
Labeling inconsistencies are a common cause of BPOM queries.
License validity: Typically 5 years
Renewal required before expiry
Post-approval changes require notification or approval, depending on impact
Unauthorized changes are treated as non-compliance.
Indonesia enforces active post-market controls:
Mandatory adverse event reporting
Field safety corrective actions
Market inspections and document audits
The local license holder carries full legal responsibility.
Israel Medical Device Regulatory Services
Israel is a high-innovation, reference-market–driven medical device environment. Market access is regulated by the Ministry of Health – AMAR Division (AMAR).
All medical devices and in-vitro diagnostics (IVDs) must be registered with the Ministry of Health before importation, marketing, or clinical use. Customs clearance and hospital procurement are tied to regulatory approval.
Israel follows a risk-based classification system aligned with EU MDR and IVDR.
Medical Devices
- Class I
- Class IIa
- Class IIb
- Class III
In Vitro Diagnostics (IVDs)
- Class A
- Class B
- Class C
- Class D
Israel is a pure reliance market.
AMAR requires prior approval from at least one recognized reference authority, such as
- EU CE marking (MDR / IVDR)
- US FDA clearance or approval
- Health Canada
- TGA (Australia)
No reference approval means no Israeli registration. There is no independent Israeli conformity assessment pathway.
Foreign manufacturers must appoint an Israel Registration Holder (IRH).
The IRH is legally responsible for
- Medical devices, IVD Product registration and renewals
- Importation and customs coordination
- Vigilance and adverse event reporting
- Recalls and regulatory communication
IRH continuity is critical. Changing holders requires formal approval and can disrupt market supply.
Singapore Medical Device Regulations
Singapore is a reference-grade, globally trusted medical device market and a regulatory gateway to ASEAN. Market access is regulated by the Health Sciences Authority (HSA).
All medical devices and in-vitro diagnostics (IVDs) must be registered with HSA before they can be imported, supplied, or used in Singapore.
Singapore follows a risk-based classification system, fully aligned with IMDRF.
Medical Devices & IVD
- Class A – Low risk
- Class B – Low-moderate risk
- Class C – Moderate-high risk
- Class D – High risk
Singapore operates a tiered reliance system.
Depending on risk class and reference approvals, HSA offers:
- Full evaluation
- Abridged evaluation
- Immediate or expedited routes
Recognized reference authorities include:
- EU (CE)
- US FDA
- Health Canada
- TGA (Australia)
- Japan PMDA
Strong reference approvals significantly reduce review time, but they do not eliminate HSA review.
Foreign manufacturers must appoint a Singapore-based Registrant licensed by HSA.
The Registrant is legally responsible for:
- Product registration and lifecycle management
- Import and supply authorization
- Vigilance and adverse event reporting
- Recalls and regulatory communication
Malaysia Medical Device Regulations
Malaysia is a fully regulated ASEAN medical device market with a structured, risk-based approval system. Market access is governed by the Medical Device Authority (MDA) under the Ministry of Health Malaysia.
All medical devices and in-vitro diagnostics (IVDs) must be registered before importation, sale, or distribution. Customs clearance and commercial supply are directly linked to MDA registration status.
Malaysia follows a risk-based classification system aligned with IMDRF.
- Class A – Low risk
- Class B – Low-moderate risk
- Class C – Moderate-high risk
- Class D – High risk
Foreign manufacturers must appoint a Malaysia-based Authorized Representative (AR) registered with MDA.
The AR is legally responsible for:
- Product registration and lifecycle management
- Import license linkage
- Vigilance and adverse event reporting
- Recalls and regulatory communication
Egypt Medical Device Regulatory Services
Egypt’s medical device market is one of the largest and fastest growing in the Middle East and North Africa (MENA) region. Importation fulfils most of local demand, with an increasing demand for SaMD, advanced diagnostics, monitoring devices, and consumables.
Estimates suggest the medical device market over USD 1 billion in recent years and projected to grow steadily through the decade, which is driven by population growth and healthcare demand.
Egypt’s medical device market is regulated by the Egyptian Drug Authority (EDA). All medical devices and in-vitro diagnostics (IVDs) must be registered with the EDA before import, sale, or distribution in the country. Registration is mandatory for every class of device, even low-risk products.
Egypt’s regulatory framework was strengthened in the late 2010s, and medical device registration has been mandatory since 2018. Recent updates have increased post-market surveillance requirements and reporting timelines, effective from early 2024.
IVDs are a rapidly expanding category due to rising demand for diagnostics and chronic disease management.
Marketing authorization for a medical device, IVD devices in Egypt encompasses several steps, including the preparation of required technical documentation, submission of the application to the EDA, adherence to classification and quality system requirements, the appointment of an ERH, and fulfilment of post-market obligations.
The EDA is the central authority responsible for:
- Classification of Medical devices
- Evaluation and approval of registration applications
- Licensing and post-market oversight
Registration is governed by national laws, including Medical Device Law No. 10 of 2003 (and subsequent updates and decrees).
Foreign manufacturers must appoint a local Egyptian Registration Holder (ERH). The ERH is legally responsible for submissions, post-market reporting, and communication with the EDA.
Medical devices are classified based on risk, following a system similar to EU risk-based categorization
- Class I – Low risk
- Class IIa – Low-moderate risk
- Class IIb – Moderate-high risk
- Class III – High risk
Class I non-sterile devices may sometimes be exempt from full registration but must still be listed with EDA records.
IVDs are also regulated as medical devices under the EDA framework, but there is a separate procedural guidance. Specific regulatory rules for IVD registration were issued in 2021 and effective from April 2021.
Key components of a medical device or IVD registration dossier in Egypt typically include:
- Device description and intended use
- Risk classification justification
- Quality management certification (ISO 13485 recommended)
- Clinical evidence or performance data
- Labelling and instructions (Arabic + English)
The EDA accepts international evidence (CE, FDA, etc.) as support, but local requirements still apply.
- Typical registration timelines range from 4–12 months, depending on device class and completeness of submission.
- Registration certificates are generally valid for 5–10 years, with IVD certificates often on a 5-year cycle.
- Post-market surveillance and adverse event reporting are enforced, with timelines based on risk level.
Once registered, products must comply with ongoing EDA requirements:
- Adverse event reporting
- Labelling updates
- Annual renewals or variations
- Importation must be through licensed importers
Post-market compliance is enforced, and non-compliance can lead to suspension or withdrawal of market access product license.
Egypt is a strategic regulatory market with a distinct local process. You cannot rely solely on CE, FDA, or other approvals. The EDA expects localized dossiers, Arabic labelling, and full compliance with registration rules.
Classifying your devices
Regulatory Intelligence.
Medical Device/IVD Registration.
Egyptian Registration Holder.
Medical Writing activities
Labelling Support.
Translation Support.
Distribution related support
Post Approval Change Management.
License Renewal and Transfer.
Customs Clearance.
Morocco Medical Device Regulatory Compliance
Morocco is a regulated and fast-opening medical device market in North Africa. Market access is controlled by the Ministry of Health and Social Protection, through its medical device directorate.
All medical devices and In-vitro diagnostics (IVDs) must be registered or notified before importation and commercialization. Customs clearance is directly linked to regulatory approval.
Morocco follows a risk-based classification system aligned with EU principles.
Medical Devices
- Class I
- Class IIa
- Class IIb
- Class III
In Vitro Diagnostics (IVDs)
IVDs are regulated under the same law but reviewed as a distinct category
High-risk IVDs such as infectious disease tests, blood screening assays, and molecular diagnostics face deeper technical and clinical review
Expert Regulatory team with proven global RA expertise
Local Agent support
Canada Medical Device Regulatory Overview
Medical devices sold or imported into Canada are regulated by Health Canada under the Medical Devices Regulations (SOR/98-282) of the Food and Drugs Act. Canada operates a risk-based system that requires both product level authorization and establishment licensing, depending on the device class and supply role.
Health Canada assesses medical devices for safety, effectiveness, and quality before they are authorized for sale.
Medical devices in Canada are classified into four risk classes based on:
- Degree of invasiveness
- Duration of contact
- Body system affected
- Potential local or systemic impact
Device Risk Class
- Class I – Low risk
- Class II – Low to moderate risk
- Class III – Moderate to high risk
- Class IV – High risk
Classification determines the regulatory pathway, documentation requirements, and review timelines.
Canada has two distinct regulatory requirements, which are often confused but serve different purposes.
- Medical Device License (MDL)
An MDL is required for Class II, III, and IV medical devices before they can be imported or sold in Canada.
Key points:
- Issued to the manufacturer
- Mandatory for each device family or group
- Requires supporting technical and quality documentation
- Valid as long as regulatory compliance is maintained
- Medical Device Establishment Licence (MDEL)
An MDEL is required for companies conducting regulated activities in Canada, such as importing or distributing medical devices.
Typically required for:
- Importers
- Distributors
- Manufacturers of Class I devices supplying the Canadian market
MDEL holders must implement and maintain all the procedures for complaint handling, recalls, and record keeping, and must renew their license on an annual basis.
Canada has a unique requirement and mandates ISO 13485:2016 certification under the Medical Device Single Audit Program (MDSAP) for manufacturers of
- Class II devices
- Class III devices
- Class IV devices
ISO 13485 alone is not sufficient for licensing, and MDSAP certification is mandatory. MDSAP certification is a pre-requisite for submitting an MDL application. Certification must be issued by a Health Canada recognized auditing organization and must cover the relevant manufacturing scope.
Without a valid MDSAP certificate
- MDL applications will be refused
- License renewals will not be processed
- Market access for Class II–IV devices is blocked
There is no alternative pathway in Canada.
Canada does not require a formal Authorized Representative for foreign manufacturers.
However
- A Canadian importer or distributor must hold an MDEL
- The importer assumes regulatory responsibility for bringing devices into Canada
- Clear contractual allocation of regulatory responsibilities is critical
Medical device labelling in Canada must
- Comply with the Medical Devices Regulations
- Be provided in both English and French
- Include mandatory information such as device identifier, manufacturer details, intended use, and warnings
Health Canada reviews MDL applications within defined service standards, which vary by device class. Actual timelines depend on
- Device posing risk and the novelty
- Completeness and quality of submission
- Responsiveness to information requests
Class I devices are not subject to MDL review but remain subject to post-market controls.
Once authorized, manufacturers, importers, and distributors must comply with ongoing obligations, including:
- Complaint handling and record retention
- Mandatory incident reporting
- Recall management
- License amendments for changes affecting safety or performance
Health Canada actively enforces post-market compliance and conducts inspections.
We support manufacturers and Canadian partners with
- Device classification and regulatory pathway strategy
- MDL and MDEL application preparation
- MDSAP readiness and remediation support
- Labelling review (English/French)
- Change management and license amendments
- Post-market compliance and regulatory intelligence
Our focus is always submission accuracy, realistic timelines, and compliance.
South Africa Market Regulatory Consulting
We use a systematic and factual approach when consulting clients in the regulatory space. South Africa’s process is not a straightforward extension of EU or FDA submissions. Whilst we can leverage global documentation, any specific South African expectations, including format and procedures, must be individually addressed.
Early regulatory assessment helps reduce delays and prevents incorrect or incomplete Health authority submissions.
We support early-stage regulatory planning by:
- Confirming medical device status under South African regulations
- Determining device right risk classification and regulatory scope
- Identifying applicable approval pathways
- Defining documentation and evidence requirements
End-to-end Regulatory consultation for product registration with South Africa market
Registration and Submission Support
We provide hands-on support for preparation and management of regulatory submissions, including:
- Submission strategy and dossier planning
- Review and compilation of technical documentation
- Alignment of clinical, risk, and performance evidence
- Labeling and instructions for use review
- Support during regulatory questions and follow-up interactions
- Post Market surveillance support
Algeria Medical Device Regulatory Overview
Algeria is one of North Africa’s most regulated healthcare markets, with increasing government oversight on imported and locally manufactured medical devices. Market access is controlled by the National Agency for Pharmaceutical Products (ANPP), which operates under the Ministry of Pharmaceutical Industry. ANPP is responsible for product registration, import authorization, post-market control, and market surveillance.
All medical devices intended for sale, import, or distribution in Algeria must comply with national regulatory requirements before commercialization. Foreign manufacturers typically face challenges related to documentation localization, administrative approvals, and coordination with local authorities.
Medical Device Classification in Algeria
Algeria follows a risk-based classification system, aligned broadly with international practices. Devices are categorized based on intended use, invasiveness, duration of contact, and potential risk to patients or users.
Typical categories include:
- Low-risk medical devices
- Medium-risk medical devices
- High-risk and implantable medical devices
- In vitro diagnostic medical devices (IVDs)
Final classification is confirmed by ANPP, particularly for borderline or innovative technologies.
- Foreign manufacturers must appoint a authorized Person locally who is responsible for regulatory submissions and post-market coordination.
- Importation without local authorization is not permitted.
- Technical documentation is submitted in line with ANPP requirements.
- Common elements include device description, intended use, risk classification, conformity evidence, and quality documentation.
- Reference country approvals (EU, FDA, etc.) are often expected.
- ISO 13485 certification is required for manufacturers.
- ANPP may request GMP or QMS evidence during review.
UK Medical Device Regulatory Overview
Medical devices, IVD devices and SaMD products placed on the UK market are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). Post Brexit, the UK operates an independent regulatory framework which is separate from the EU regulation, with its own conformity marking as UKCA, registration rules, and post-market compliance.
Manufacturers must comply with UK specific requirements before supplying devices in Great Britain (England, Scotland, Wales). Northern Ireland follows a different pathway aligned with EU rules EU MDR or IVDR certified devices transitional arrangements allow continued use of CE marking for a limited period, but the UK is progressively moving toward full UKCA adoption.
- UKCA Conformity Assessment (Great Britain)
The UKCA (UK Conformity Assessed) marking is the UK’s standalone conformity mark. Devices must demonstrate compliance with UK MDR essential requirements.
Class I (non-sterile, non-measuring): Self-certification
Higher-risk devices: Assessment by a UK Approved Body (once designated)
- CE Marking (Transitional Acceptance)
The UK currently accepts CE-marked devices for a defined transition period, subject to MHRA registration. This pathway is time-limited and should be treated as interim.
All medical devices must be registered with MHRA before being placed on the GB market.
Registration is mandatory for all classes and timelines depend on risk class
UK Responsible Person (UKRP)
Manufacturers located outside the UK must appoint a UK Responsible Person (UKRP).
The UKRP role and responsibilities
Acts as the primary regulatory contact with MHRA
Ensures device registration is completed
Holds access to technical documentation on behalf of the manufacturer
Supports vigilance reporting and field safety actions
Without a UKRP, non-UK manufacturers cannot legally place devices on the GB market.
The UK follows a risk-based classification system broadly aligned with EU rules:
ISO 13485 must be implemented by medical device manufacturers, and scope must align with device classification and intended use. Higher risk devices require third party conformity assessment
We support with
- UK device classification and regulatory pathway strategy
- UK Responsible Person services
- MHRA device registration and account management
- UKCA readiness and transition planning from CE
- QMS gap analysis
- Technical documentation review and remediation
- Post-market surveillance and vigilance support
Turkey Medical Device Regulatory compliance
Turkey operates one of the most EU-aligned medical device regulatory systems outside the EU. Market access is governed by the Turkish Medicines and Medical Devices Agency under the Ministry of Health.
All medical devices and In-vitro Diagnostics (IVDs) must be registered in Turkey’s national database before they can be imported, distributed, or sold.
Turkey has fully transitioned from legacy directives to EU MDR and IVDR–aligned regulations.
Key milestones:
- Medical Device Regulation (MDR-aligned): Effective 26 May 2021
- IVD Regulation (IVDR-aligned): Effective 26 May 2022
- National implementation enforced through TİTCK guidance and the UTS system
Turkey does not recognize MDD or IVDD certificates issued after the EU transition deadlines. MDR and IVDR compliance is now mandatory.
Turkey follows EU risk classification rules.
Medical Devices
- Class I
- Class IIa
- Class IIb
- Class III
In Vitro Diagnostics (IVDs)
- Class A
- Class B
- Class C
- Class D
Turkey Local Authorized Representative
As due to the custom union agreement, the EU manufacturers do not require to appoint a local authorised representative to place their devices in the market.
Other foreign manufacturers are required to appoint a European Authorised Representative (EAR) to place the devices in the Turkey market.
Serbia Medical Device Regulatory support
Serbia is a regulated, EU-aligned medical device market and a strategic entry point into the Western Balkans. Medical devices and In-vitro diagnostics (IVDs) are regulated by the Medicines and Medical Devices Agency of Serbia (ALIMS).
All medical devices and IVDs, SaMD must be registered or listed with ALIMS before importation and commercial distribution. Customs clearance is directly linked to regulatory status.
Serbia’s current framework is built on EU alignment, even though Serbia is not yet an EU Member State.
Serbia follows EU risk-based classification rules.
Medical Devices
- Class I
- Class IIa
- Class IIb
- Class III
In Vitro Diagnostics (IVDs)
- Class A
- Class B
- Class C
- Class D
IVD classification mirrors EU IVDR logic:
- Public health impact
- Clinical decision relevance
- Screening vs diagnosis
- Risk to patient or population
High-risk IVDs such as infectious disease assays, blood screening tests, genetic and molecular diagnostics receive more scrutiny.
Foreign manufacturers must appoint a Serbia-based Authorized Representative or local representative.
The representative is responsible for:
- Product registration with ALIMS
- Regulatory communication
- Vigilance and adverse event reporting
- Recall coordination
Saudi Arabia
Saudi Arabia is among the Middle East’s most regulated and strategically significant healthcare markets. Products entering this market must comply with established regulatory procedures, local representation standards, and continuing post-market obligations.
The Saudi Food and Drug Authority (SFDA) is in charge of central regulatory approvals.
We provide Saudi Arabian manufacturers, distributors, and brand owners regulatory consulting services that cover market entry, registration, and lifecycle compliance for pharmaceuticals, health products, and medical devices.
SFDA regulates
- Medicinal products
- Food and health supplements
- Medical devices and in vitro diagnostics
- Cosmetics and related products
Regulatory Consulting for Medical Devices
While international approvals can be leveraged, Saudi Arabia maintains country-specific requirements, particularly for documentation format, local representation, labeling, and post-market controls.
Medical devices and IVDs are regulated by SFDA under Saudi medical device regulations. Market entry depends on device risk class, reference country approvals, and local representation.
Key Regulatory Requirements
- Appointment of a Saudi Authorized Representative
- Device classification based on risk
- Electronic submission through SFDA systems
- Compliance with applicable quality system requirements
- Arabic and English labeling where required
Saudi Arabia applies a four-class risk-based classification system. Classification is aligned with international principles but applied under Saudi regulations.
SFDA allows manufacturers to
- Grouping of models and variants, where justified
- Formal classification requests for borderline products
Correct classification is critical, as it determines the applicable approval pathway and review depth.
Approval Pathways
- As SFDA abolished the MDNR procedure as a standalone registration route in 2022. All medical devices, regardless of product risk class, now require a Medical Device Marketing Authorization (MDMA) with a complete technical file and local representation. Hence, all medical devices now require a full MDMA application, even those previously eligible for MDNR.
- This aligns with SFDA modernization of the medical device regulatory framework, which consolidated device entry pathways under the GHAD unified electronic system and emphasized, strengthened technical file requirements.
Approval timelines depend on device class, completeness of submission, and SFDA review workload.
Foreign manufacturers without a legal presence in Saudi Arabia must appoint an SFDA-licensed Authorized Representative. The AR:
- Available locally and acts as the regulatory liaison with SFDA
- Manages regulatory submissions and approvals
- Supports post-market compliance and communications
- Coordinates for product changes, renewals, and recalls
Like any regulatory authorities, SFDA emphasizes post-market controls. Manufacturers and representatives must manage:
- Changes to approved devices or products
- Renewal of approvals and listings
- Maintenance of regulatory records
- Communication with SFDA on compliance matters
Failure to manage lifecycle obligations can result in suspension or cancellation of approvals.
Our services include
- Regulatory pathway and classification strategy
- Local representation coordination
- Dossier gap analysis and remediation planning
- Submission preparation and electronic filing
- SFDA query management and follow-up
- Post-approval change and renewal support
- UDI
- Labelling
- Translations
- Regulatory intelligence and compliance updates
UAE Medical Device Regulations
The United Arab Emirates (UAE) is one of the most regulated and commercially attractive medical device markets in the Middle East. Market access is controlled by the Ministry of Health and Prevention (MOHAP). All medical devices and In-vitro diagnostics (IVDs) must be registered and listed with MOHAP before any import, distribution, or sale activity in the UAE. There are no exemptions for “low risk” imported products.
The UAE follows a risk-based classification system aligned with GHTF/IMDRF principles, very similar to the EU classification system.
Medical Devices
- Class I
- Class IIa
- Class IIb
- Class III
In Vitro Diagnostics (IVDs)
IVDs are regulated separately from general devices, even though they fall under the same law.
IVD risk is based on:
- Clinical impact of the result
- Disease severity
- Target population
- Self-testing vs professional use
High-risk IVDs such as infectious disease tests, blood screening assays, genetic tests, and companion diagnostics are treated as high-scrutiny products.
The UAE is a reference-market–based system.
MOHAP requires prior approval from at least one recognized authority, typically:
- EU CE marking
- US FDA clearance or approval
- Health Canada
- TGA (Australia)
- Japan PMDA
No reference approval means no UAE registration. There is no standalone local approval pathway.
Foreign Manufacturers who don’t have physical office shall appoint a Local Representative (LR). The applicants may appoint their distributor as their Local Representative. However, having an independent Local Representative, with no commercial interest, would provide the required flexibility to appoint multiple distributors in the UAE. The details of both the LR and the distributor must be provided during device registration.
The AR is legally responsible for:
- Product registration and listing
- Import license linkage
- Vigilance and adverse event reporting
- Recalls and regulatory communication
An incorrect AR setup blocks renewals, variations, and even customs clearance.
Typical MOHAP submission includes:
- Reference market approval evidence
- Device classification and intended use
- ISO 13485 certificate
- Technical documentation summary
- Labelling and IFU (English required, Arabic recommended)
- Post-market surveillance commitment
For IVDs, additional performance and clinical justification is often requested.
Medical Device Regulatory Overview
Medical devices marketed in Argentina are regulated by Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). Argentina follows a pre-market approval system, and devices must be formally registered before import, distribution, or sale.
For foreign manufacturers, Argentina is a structured but documentation-intensive market. Success depends on correct classification, a compliant local representative, and well-prepared technical files aligned with ANMAT resolutions and MERCOSUR principles.
- National medical device resolutions issued by ANMAT
- Alignment with MERCOSUR technical regulations
- Risk-based classification and mandatory pre-market registration
ANMAT has strengthened enforcement in recent years, with closer review of technical documentation, labeling accuracy, and post-market compliance.
- Competent Authority: ANMAT
- Scope: Medical devices, IVDs, active implantable devices, accessories, and certain software with medical intent
Argentina requires device registration prior to commercialization. There is no notification-only or fast-track entry for standard medical devices.
Key steps:
- Appointment of a licensed local holder
- Manufacturer and product registration
- Technical review and approval by ANMAT
- Issuance of registration certificate
Brazil Medical Device Regulatory Services
Brazil is the largest and most tightly regulated medical device market in Latin America. Market access is controlled by Agência Nacional de Vigilância Sanitária (ANVISA) at the federal level.
All medical devices and in-vitro diagnostics (IVDs) must be registered or notified with ANVISA before import, distribution, or sale. Customs clearance is directly linked to ANVISA status.
Foreign manufacturers must appoint a Brazil Registration Holder (BRH).
The BRH is legally responsible for:
- Product registration and lifecycle management
- Import licensing
- Vigilance and adverse event reporting
- Recalls and regulatory communication
Changing the BRH is complex and high-risk if not planned properly. It directly affects market continuity.
Brazil enforces ANVISA GMP certification for many device classes.
Key reality:
- ISO 13485 alone is often not sufficient
- ANVISA may require on-site GMP inspection
- Inspection timelines must be built into the market strategy
This is one of the largest timeline drivers for Brazil approvals.
Australia Regulatory Consulting and TGA Registration
Australia is a mature and highly regulated medical device market. Medical devices and in vitro diagnostic devices must comply with national regulatory requirements before they can be supplied, imported, or marketed in Australia. Regulatory oversight focuses on patient safety, clinical performance, and lifecycle compliance.
The Therapeutic Goods Administration (TGA) is responsible for regulating medical devices within Australia under the Therapeutic Goods Act. All medical devices, IVD devices must be registered with the Australian Register of Therapeutic Goods (ARTG) before being sold commercially.
The TGA maintains a risk-based regulatory framework that is consistent with the global framework for medical devices but also has specific procedures and documentation requirements that are unique to Australia. Therefore, if your company is located outside of Australia, it will need to appoint an Australian-based sponsor to act as the legal representative for the purpose of ensuring compliance with the applicable regulations.
We support medical device manufacturers with end-to-end regulatory consulting for the Australian market, from classification and submission strategy through ARTG inclusion and post-market compliance.
Medical device market entry in Australia is based on:
- Correct device classification
- Evidence of conformity assessment
- A compliant Quality Management System
- Submission and inclusion in the ARTG
While Australia recognizes overseas conformity assessment evidence, inclusion is not automatic. Submissions are reviewed for completeness, consistency, and applicability to the Australian regulatory framework.
A certified Quality Management System is a core regulatory requirement for most medical device classes. Australia accepts ISO 13485 certification, including certification issued under the Medical Device Single Audit Program (MDSAP), provided the scope covers the device and manufacturing activities.
Australia follows a risk-based classification system broadly aligned with EU principles. Devices are classified according to intended purpose, duration of use, and degree of invasiveness.
Medical Devices
- Class I – Low risk
- Class IIa – Low to moderate risk
- Class IIb – Moderate to high risk
- Class III – High risk
- Active Implantable Medical Devices– Highest risk
IVD Medical Devices
- Class 1 – No public health risk or low personal risk
- Class 2 – Low public health risk or moderate personal risk
- Class 3 – Moderate public health risk or high personal risk
- Class 4 – High public health risk
Correct classification is a critical step in the regulatory pathway.
Non-Australian manufacturers must appoint an Australian sponsor who is responsible for
- Submitting and maintaining ARTG entries
- Answering TGA queries
- Reporting adverse events and incidents
- Managing recalls and corrective actions
- Maintaining regulatory compliance on an ongoing basis
The sponsor and manufacturer share regulatory accountability. Choosing the right sponsor arrangement is a critical compliance decision.
ARTG inclusion is not the end of regulatory responsibility. Manufacturers and sponsors must maintain ongoing compliance throughout the product lifecycle.
We support post-market activities including:
- Assessment and submission of device changes
- Variant and model additions
- Intended use updates
- Annual ARTG charge management
- Incident reporting and recalls
- Regulatory intelligence and change impact analysis
Australia has increased post-market surveillance activity in recent years, particularly for software-driven and high-risk devices.
Our Australia TGA services include
- Regulatory pathway and classification strategy
- Sponsor support coordination
- ARTG submission planning and compilation
- Conformity assessment evidence review
- Audit readiness and response support
- Post-market change management
- Ongoing regulatory intelligence
We focus on regulatory accuracy, realistic timelines, and sustainable compliance.
New Zealand Medical Device Regulatory Consulting
New Zealand medical devices strong emphasis on supplier responsibility and post-market control rather than extensive pre-market approvals. Medical devices supplied in New Zealand are regulated by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), under the Ministry of Health.
Manufacturers and suppliers must understand that while market entry is comparatively streamlined, accountability for safety, performance, and compliance rests squarely with the local sponsor throughout the product lifecycle.
Under the current framework, pre-market approval is not required for medical devices. Instead, New Zealand operates a notification-based system supported by post-market surveillance and enforcement.
Proposed reforms to introduce a more approval-based system, but no new medical device legislation is currently in force. The existing regulatory model remains applicable.
The WAND database was established by the Medicines (Database of Medical Devices) Regulations 2003 to collect information about medical devices supplied in New Zealand. It is a mandatory requirement for importers, exporters and local manufacturers to notify their medical devices to the database. WAND is not an approval system for medical devices.
There is no approval system for medical devices under the Medicines Act 1981. There is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand. Notification to the WAND database does not mean or imply that a medical device has been assessed by Medsafe in terms of quality, safety, efficacy, or performance.
It is, though, a mandatory requirement for importers, exporters and New Zealand manufacturers to advise the Director-General of Health, via the WAND database, of the devices that are supplied here.
Medical devices must be notified in the Web Assisted Notification of Devices (WAND) database within 30 days of first supply in New Zealand.
Key points to understand:
- WAND is a legal notification requirement, not an approval
- Medsafe does not assess technical files at the time of notification
- Devices may be supplied once notified, provided regulatory obligations are met
- There are no government fees for submitting a WAND notification.
Incomplete or inaccurate WAND notifications are a common compliance issue and may trigger follow-up action by Medsafe.
Indonesia requires full device registration prior to commercialization.
Core steps:
Appointment of a licensed Indonesian local license holder
Product classification and grouping
Technical dossier preparation
BPOM electronic submission and review
Every medical device supplied in New Zealand must have a local Sponsor. New Zealand based Sponsor is legally responsible for:
- Ensuring the device meets local regulatory requirements
- Submitting and maintaining WAND notifications
- Holding technical and conformity documentation
- Managing post-market surveillance and reporting adverse events, and responding to safety issues
- Acting as the primary regulatory contact with Medsafe
For overseas manufacturers, sponsor selection is a critical regulatory decision, as Medsafe places enforcement responsibility on the Sponsor rather than the foreign manufacturer.
Devices notified in WAND are assigned a risk classification based on international risk principles, which helps Medsafe track device types and intended use, but classification does not affect the need for notification.
Certain devices are exempt from WAND notification under defined conditions (for example, devices used only for a specific patient or imported for clinical trials).
In vitro diagnostic devices (IVDs) are considered exempt from mandatory notification but may be voluntarily notified.
We can help you to bring your medical devices, IVD devices, SaMD seamlessly. Our qualified team of experts with hands on experience for multiple products. We help our clients for End-to-end consultation while ensuring structured approach to make sure for a quick market access.
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