The Central Drugs Standard Control Organization (CDSCO) has released a pivotal document: the Draft Guidance for Import of In-Vitro Diagnostic (IVD) Medical Devices (No. CDSCO/IVD/GD/DRAFT/IMP/01/2026). This consolidated reference is designed to streamline the application process for importers, ensuring “completeness and accuracy for getting timely approval” under the Medical Devices Rules, 2017 (MDR-2017). 

As regulatory experts, we have analyzed this guidance to help you understand its implications and how to leverage it for your commercial and clinical objectives. 

What is this draft Guidance? 

This document serves as a comprehensive guide for submitting product license applications through the “cdscomdonline” and “NSWS” portals. It covers the entire regulatory pathway—from development to commercialisation—and clarifies the standards, procedural steps, and compliance obligations for all classes of IVDs. 

Crucially, the CDSCO has placed this draft in the public domain for stakeholder comments, providing a 15-day window from the date of publication for industry feedback via a specific Google form link. 

How This Document Facilitates Your Market Entry 

1. Defined Portals and TimelinesClarityon digital infrastructure is essential. The guidance specifies that Form MD-14 (Commercial Import License) applications must be submitted via the MD Online Portal, while Form MD-16 (Test License) applications use the NSWS portal. Regulatory timelines are now explicit: 270 days for MD-14 and 30 days for MD-16.

2. Risk-Based ClassificationIVDs, including kits, reagents, instruments, analyzers, and software, are classified by risk:

• Class A: Low Risk. 

• Class B: Low Moderate Risk. 

• Class C: Moderate High Risk. 

• Class D: High Risk.

3. Categorization of ApplicationsThe guidance distinguishes between various application types to ensure you select the correct pathway:

• Test License (MD-16): For limited quantities used for testing, evaluation, demonstration, training, or clinical investigation (non-commercial). 

• Fresh License: For first-time imports. 

• Endorsement: Adding new products or variants to an existing license. 

• Retention: Renewal or extension of a current license. 

• Subsequent Importer: Applying for a device already licensed to another agent, provided manufacturing sites remain the same. 

Critical Documentation Requirements 

Success hinges on adhering to the exhaustive checklists provided in the guidance. Key highlights include: 

• Power of Attorney (POA): This must be co-jointly signed and stamped by the manufacturer and Indian Agent, and apostilled or authenticated by an Indian Embassy or a First Class Magistrate. 

• Free Sale Certificate (FSC): Required from the Country of Origin and, for certain pathways, from GHTF countries (USA, Australia, Canada, Japan, UK, or EU member states). 

• Performance Evaluation Report (PER): Mandatory for three independent batches of specific IVDs, including those for HIV, HBV, HCV, Tuberculosis, Malaria, Dengue, Cancer markers, and markers for congenital disorders. 

• Quality Management System (QMS): Valid, notarized ISO 13485 certificates are required for both legal and actual manufacturing sites. 

Expert Analysis: Avoiding Common Non-Compliance Rejections 

The CDSCO has included a vital “List of Common Non-Compliance Observed” to help applicants avoid pitfalls: 

• Signatory Mismatches: The individual signing the legal form must match the signatory on the covering letter. 

• Technical Discrepancies: Product names, model numbers, and manufacturing addresses must be identical across all documents, including the POA, FSC, and labels. 

• Authentication Failures: Common errors include missing notarizations on site registrations or submitting documents in foreign languages without certified translations. 

• Fee Errors: Applications often fail if the site registration fee is missed for fresh applications or if insufficient fees are paid for higher-risk class endorsements. 

Stakeholder Roles and Public Health 

The guidance reaffirms that the Foreign Manufacturer is responsible for safety and quality, while the Authorized Indian Agent serves as the legal representative responsible for regulatory interactions and post-market compliance, such as reporting adverse events or recalls. 

Conclusion For stakeholders in the IVD sector, this draft guidance is an invaluable tool for ensuring regulatory predictability. We recommend a thorough review of your current documentation against these new checklists to ensure your next submission is “complete and accurate” for timely approval. 

Source: Guidance for Import of In-Vitro Diagnostic Medical Device  

Disclaimer : This summary prepared is for public awareness and is not intended for any legal or professional purposes; readers should refer to the statutory provisions of the Medical Devices Rules, 2017.