The MedTech industry is expanding at historic rates, driven by innovation across diagnostics, wearables, imaging technologies, and AI-based health solutions. But for start-ups, taking these ideas to market-product ready is no cakewalk. Being compliant with regulations remains the biggest challenge — and in 2025, the benchmark has never been higher.

Before it reaches patients as a new device, such as a handheld ultrasound scanner, remote patient monitoring wearable, or AI-based diagnostic platform, it must undergo intense frameworks for safety and effectiveness. As there is more harmonisation of the world, changing data protection laws and increasing demands for openness with artificial intelligence, startups encounter nuanced issues whose impact is directly seen in their time-to-market.

The article elucidates the three major regulatory issues that threaten MedTech startups in 2025, and then guides on the route bypassing them.

Overly Complicated and Fragmented Approval Frameworks

India: CDSCO & Medical Device Rules 2017

Control over medical devices in India is with the Central Drugs Standard Control Organisation (CDSCO) in line with the Medical Devices Rules (MDR) 2017. They are categorized Class A (lower risk) to Class D (higher risk).

Meanwhile, this classification is generally Class C or D for startups developing digital diagnostics, implantable devices, or AI-based monitoring devices, which involves:

• Elaborated technical files
• Compliance with ISO 13485 quality management
• Pre-clinical and clinical testing

Top Challenges in India

• Multi-tiered Approvals: Higher-class devices require both central as well as state clearances, which delay timelines.
• Unclear Classification: Those kinds of technologies, say AI-based wearables, do not fall into straightforward classifications on the traditional way of looking at it.
• Administrative Roadblocks: Delays and procedure-based barriers exist even after digitisation.
• Limited Pre-Submission Support: Unlike in the U.S., India offers less structured pre-submission consultations.

United States: FDA Pathways

The United States' Food and Drug Administration (FDA) remains the world's strongest regulatory body. Devices can be cleared through:

• 510(k): For devices that are considerably similar to an already approved device.
• PMA (Premarket Approval): For new, high-risk devices with a strong requirement for clinical evidence.
• De Novo: For new devices with no predicate.

Startups also need to comply with the Quality System Regulation (21 CFR Part 820) and, in the case of software-controlled devices, the FDA's SaMD guidance.

New Issue: Review periods are extending owing to heavy workloads and a shortage of staff, most strongly on PMA submissions.

Top Challenges in the USA:

• Lengthy and unpredictable review timelines, especially for PMA approvals.
• High costs associated with clinical trials, testing, and compliance.
• Complex regulatory documentation and frequent changes in FDA guidance.
• Limited regulatory clarity for novel technologies, including AI-driven and digital health devices.
• Resource constraints for startups, as navigating FDA pathways requires significant expertise and investment.

Europe: CE Marking Under MDR 2017

In Europe, regulatory compliance is under the EU Medical Device Regulation (MDR) 2017/745, which took full effect in May 2021. The manufacturer needs a CE mark of conformity with MDR to sell a medical device in the EU. They are categorized into Class I, IIa, IIb, and III, with Class III being the highest risk (equivalent to PMA-level review in the U.S.).

Requirements for Startups:

• Technical Documentation: Comprehensive design, manufacturing process, and clinical evaluation report.
• Quality Management System: ISO 13485 compliance is a must.
• Clinical Evaluation: Clinical data should be comprehensive, particularly for Class IIb and III devices.
• Notified Body Assessment: Contrary to the FDA, Europe uses Notified Bodies, third-party firms that audit compliance prior to CE marking.

Top Challenges in Europe:

• Severe Notified Body Shortage: After MDR implementation, notified body numbers fell, leading to serious approval delays.
• Sophisticated Clinical Needs: MDR has more stringent clinical evidence requirements, even for current devices.
• Compliance Expenses: Especially for SMEs and new companies, MDR compliance expenses are much higher than under past directives.
• Bottlenecks of Transition: The longer MDR transition period resulted in delays in certifications, which held up entry into the market.

This is where NexorTest Technologies and its team of regulatory experts can help you out -

1. Right Path, First Time We guide startups to the correct regulatory route (CDSCO, FDA, or EU MDR) and avoid costly misclassification or wrong submissions.
2. Faster Approvals Our experts streamline documentation and technical files, reducing back-and-forth with regulators.
3. Affordable Compliance Ready-made templates, SOPs, and QMS packs help startups meet ISO 13485/QMSR without ballooning costs.
4. Clinical & Tech Clarity We design lean testing and clinical strategies that meet evidence requirements without overspending.
5. Global Market Access One partner for India, US, and EU approvals — cutting time-to-market and ensuring smooth entry across regions.