Rule 36(3): Free Sale Certificates from Six Reference Jurisdictions for India Imports

1. Key takeaways

Rule 36(3) of the Medical Devices Rules, 2017 lists six reference jurisdictions: Australia, Canada, Japan, the European Union member states and the United States, plus the United Kingdom, which was added under G.S.R. 174(E), effective March 4, 2022. Where a device has been granted a free sale certificate (FSC) by the national regulatory agency or equivalent competent authority of any one of these jurisdictions, the import licence issued under Rule 36(1) requires no clinical investigation in India. Where that FSC is absent, the pathway splits by class: Class C/D devices follow Rule 36(4) and must complete a clinical investigation in India, while Class A/B devices follow Rule 36(5) and may proceed through an alternative route based on published data. The practical weight of this single rule is hard to overstate: it determines whether an import project is a documentation exercise measured in months or a clinical programme measured in years, and it applies at the level of the certificate issuer, not the country of manufacture, which is the detail most frequently misread by applicants preparing their first India submission.

2. Legal basis

The provisions below set out the six-jurisdiction mechanism, the way the United Kingdom was inserted into the list, and the fallback routes for devices whose certificates do not come from the listed jurisdictions.

3. Expert insights

Insight one: the test looks at the FSC issuer, not the country of manufacture. An FSC issued by the German competent authority secures the clinical investigation exemption for a product manufactured in China; an export sales certificate issued by the Chinese regulator does not. This judgement criterion is almost never explained clearly in Chinese-language materials, and the resulting confusion causes a large number of companies to misjudge their own pathway and budget before anyone has checked the certificate against the rule.

Insight two: European Union member states are counted country by country, not as a single bloc. The text of the rule reads “European Union Countries”. Holding an FSC issued by any one member state is sufficient, but the issuing body must be that country’s national regulatory agency or equivalent competent authority — not a notified body and not an industry association. A certificate with the wrong kind of issuer looks similar on paper and fails the test at review.

Insight three: IVDs are the single exception. Approval in one of the six jurisdictions operates as a passport exempting ordinary devices from clinical investigation, but for a new IVD it has no such effect. CDSCO’s answer to Question 68 is explicit: regardless of regulatory status in those countries, the clinical performance evaluation of a new IVD must be done in India. This single line separates the cost structure of an IVD project from that of an ordinary device project completely, and it should be surfaced in any portfolio-level decision about which products to send to India first.

Insight four: the two-year marketing history is a second gate. Even where a device without an Indian predicate secures approval in one of the six jurisdictions, if it has not been marketed in that country for two years, the proviso to Rule 63(1) does not apply. A newly approved product from a reference jurisdiction is therefore not the same thing as a product that has earned the Indian exemption; the clock must have run its course in the reference country before the Indian route opens.

4. Practical recommendations

• Maintain a six-jurisdiction evidence matrix: the jurisdictions across the top, product models down the side, and in each cell the full name of the FSC issuing authority, the issue date, the validity period and the coverage scope (models and variants). Once the matrix exists, the customer can see immediately which models fall inside the threshold and which fall outside.
• Verify, certificate by certificate, that the issuing body is a national regulatory agency or equivalent competent authority of a listed jurisdiction — not a notified body, not an association.
• For Class C/D products outside the threshold, compare the two paths with the customer explicitly: first obtaining market authorisation in one of the six jurisdictions (including the two-year marketing history) versus conducting the clinical investigation directly in India, and judge which fits the customer’s global rhythm better.
• Check every new IVD project against Question 68 at the start, so the clinical performance evaluation is budgeted from the outset rather than discovered at review.

5. Verification checklist

• □ Each FSC issuing authority has been checked line by line against the six-jurisdiction list
• □ The issuing body is a national regulatory agency or equivalent competent authority (not a notified body, not an association)
• □ The FSC covers all models and variants proposed for the application
• □ For devices without a predicate, the two-year marketing history in the reference jurisdiction has been verified
• □ IVD projects have been assessed separately against Question 68 (six-jurisdiction approval does not exempt the CPE)

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