Devices Without Six-Jurisdiction FSC Approval: The India Pathway for Class A/B and C/D

1. Key takeaways

For devices that hold no free sale certificate from the six reference jurisdictions, India does not close the door; it opens two different doors depending on risk class. Class C/D devices, under Rule 36(4), may only be licensed after their safety and effectiveness have been demonstrated by a clinical investigation conducted in India. Class A/B devices, under Rule 36(5), may instead be supported by published safety and performance data or by a clinical investigation conducted in the country of origin, provided that an FSC from the country of origin is also submitted. The cost gap between the two routes is measured in multiples, not percentages: one route is a literature and documentation exercise, the other a full clinical programme executed inside India with its own licensing layer on top. Because most manufacturers first encounter this distinction when a portfolio is being triaged for India entry, understanding exactly what each rule asks for — and what each rule does not ask for — is the difference between a staged, affordable market entry and a stalled application discovered late in the process.

2. Legal basis

The provisions below set out the two alternative routes for devices from countries outside the six-jurisdiction list, the licensing layer needed to run a clinical investigation, the treatment of devices without a predicate, and the official FAQ confirmation of both routes.

3. Expert insights

Insight one: the Class A/B alternative route is seriously underestimated. Rule 36(5) allows the case to be supported by published safety and performance data — that is, literature and publicly available clinical evidence — with no new trial conducted in India. For mature product categories with a deep body of international literature, such as infusion sets, syringes and basic monitoring equipment, this route costs far less than the Class C/D pathway and can move on a documentation timetable rather than a clinical one.

Insight two: the price of the Class C/D route is the full Chapter VII process. It is not simply a matter of running a trial. It includes the MD-22 application, ethics and technical review, the MD-23 licence, conduct of the investigation, reporting, and the subsequent return to the MD-14 import application. The INR 100,000 figure is the government fee only; the cost of the investigation itself is of another order of magnitude entirely, and the elapsed time is driven by site, ethics and subject recruitment factors that sit outside the statutory clocks.

Insight three: the country-of-origin FSC is a mandatory component of the Class A/B route. Note carefully that what is required here is an FSC issued by the country of origin, not a six-jurisdiction FSC. An export sales certificate issued by the Chinese regulator is useful at this step: it satisfies the “FSC from the country of origin” condition of Rule 36(5), even though it does not satisfy the clinical investigation exemption of Rule 36(3). The same document can therefore be insufficient for one purpose and sufficient for another, depending on which rule is being applied.

Insight four: this route carries a hidden gate — the English quality of the technical file. When published literature replaces a clinical trial, what the reviewer examines is the systematic quality of the literature and how precisely it maps onto the product. A list of papers assembled casually, without a structured linkage to the device as submitted, will be sent back for supplementation, and each such round consumes time that no statutory provision protects.

4. Practical recommendations

• For customers without six-jurisdiction approval, the first recommendation is usually portfolio tiering: push Class A/B models into India first (via Rule 36(5), at lower cost and on a shorter cycle), defer the Class C/D models, and in parallel begin building a market authorisation presence in one of the six jurisdictions.
• Where a Class C/D product must enter immediately, commission an evidence sufficiency pre-assessment first, to judge what form of clinical evidence CDSCO is likely to require, and only then decide between running the Indian clinical investigation and strengthening the six-jurisdiction position first.
• Prepare the mapping between the literature package and the device as submitted before filing, so that the correspondence argument is explicit rather than left for the reviewer to construct.
• Confirm which rule each existing certificate will be used under, so that a single document is never counted on to satisfy a condition it does not actually meet.

5. Verification checklist

• □ The applicable rule, 36(4) or 36(5), has been determined by risk class
• □ For Class A/B, the published literature package and the country-of-origin FSC are ready
• □ For Class C/D, the MD-22 → MD-23 clinical investigation has been planned (fee INR 100,000)
• □ For devices without a predicate, the need to proceed via MD-26 → MD-27 first has been assessed
• □ The correspondence explanation between the literature package and the product has been prepared

Regulatory information verified as of October 27, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com