Free Sale Certificate for India: Requirements and Rejection Risks

1. Key takeaways

The Free Sale Certificate (FSC) in India serves two distinct functions. Where the FSC is issued by the national regulatory authority or an equivalent competent authority of one of the six countries (Australia, Canada, Japan, an EU member state, the United States, or the United Kingdom), it can support an exemption from clinical investigation under Rule 36(3). Where no six-country FSC is available, Class A and Class B still require a country-of-origin FSC under Rule 36(5). The issuing body required by the two functions is different, and confusing them is the most common mistake.

• Two provisions, two thresholds: Rule 36(3) looks at who issued the certificate, Rule 36(5) looks at where it was issued.
• A Chinese export sales certificate satisfies the country-of-origin route but not the six-country route.
• The FSC evidences free sale, not that the product has been assessed as safe and effective.
• Some IVD pathways may require a country-of-origin FSC and a GHTF-country FSC together.
• The issuing authority, validity, and product details must align exactly with the MD-14 application.

2. Legal basis

The two FSC functions sit in different sub-rules of Rule 36, and the supporting guidance adds consistency requirements. The table below sets out the position for each item.

3. Expert insights

Insight one: one term, two thresholds. “Free sale certificate” appears in two provisions of Indian regulation with different requirements: Rule 36(3) requires a certificate issued by a competent authority of one of the six countries, while Rule 36(5) requires one issued by the country of origin. The export sales certificate issued by the Chinese drug regulator satisfies the latter but not the former. Applicants who assume a single FSC covers both purposes will discover the gap only when the deficiency letter arrives.

Insight two: the FSC proves free sale, not that the product has been reviewed as safe and effective. According to India’s public explanation, the FSC is a certificate issued by the competent authority of the exporting country under its own legislation confirming that the product is freely sold in that country; it does not mean that the product has been evaluated as safe and effective in the exporting country. Once this is understood, it becomes clear why India still conducts its own review after receiving the FSC. The certificate opens the door; it does not carry the product through it.

Insight three: IVD pathways may require two certificates. The draft IVD import guidance notes that some pathways require a country-of-origin FSC and a GHTF-country FSC side by side. This adds a separate, and sometimes lengthy, evidence-collection task to the project plan. For manufacturers whose product is registered in a GHTF market, this is largely administrative; for those who are not, it can reshape the timeline. The practical consequence is that the FSC workstream should be started at the same time as the technical file, not after it, because the certificate may depend on registrations held in another jurisdiction.

Insight four: the three elements of the FSC must match the other documents. The issuing authority, the validity period, and the product and manufacturer information must be strictly consistent with the MD-14 application. The CDSCO requires applicants to provide a page-by-page, item-by-item comparison table between the MD-14 and the FSC, with page numbers and item numbers. This is a clerical deliverable, but it is precisely the kind of deliverable that absorbs review time when it is missing.

4. Practical recommendations

GRZAN asks clients to confirm three things before obtaining an FSC: first, whether the issuing body is a national regulatory authority or equivalent competent authority — not a notified body and not an association; second, whether the certificate covers all models and variants included in the application; third, whether the validity period covers the expected review cycle. We also prepare a page-by-page FSC-to-MD-14 comparison table as part of the submission package — it is a deliverable explicitly required in the draft IVD guidance, and preparing it in advance avoids one full round of questions.

• Decide at the outset whether the project relies on Rule 36(3) or Rule 36(5), and obtain the matching certificate.
• Verify the issuing body is a regulator or equivalent competent authority before requesting the document.
• Check that the certificate lists every model and variant in the application, not only the lead product.
• Confirm the validity period covers the expected review cycle with margin.
• Build the page-by-page comparison table as a standard component of the submission package.

5. Verification checklist

• □ It is clear whether the FSC function for this project is Rule 36(3) or Rule 36(5)
• □ The issuing body is a national regulatory authority or equivalent competent authority
• □ The certificate covers all models and variants
• □ The validity period covers the expected review cycle
• □ A page-by-page, item-by-item FSC-to-MD-14 comparison table has been prepared

Regulatory information verified as of 27 October 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