China Manufacturers and the India Medical Device First Hurdle

1. Key takeaways

For Chinese manufacturers entering India, the first hurdle is not language and not fees, but the recognised-country list of Rule 36(3) of the Medical Devices Rules, 2017. The list names Australia, Canada, Japan, the EU member states and the United States, together with the United Kingdom added under G.S.R. 174(E) (in force from 4 March 2022). China is not on the list. Where the product does not hold a free sale certificate issued by the competent authority of any listed party, Class C/D devices must complete a clinical investigation in India under Rule 36(4), and Class A/B devices must rely on publicly available safety and performance data or a clinical investigation in the country of origin, together with the country-of-origin FSC, under Rule 36(5). Everything else in the project — fees, timeline, evidence strategy — is downstream of this single determination.

• The recognised list is Rule 36(3): Australia, Canada, Japan, EU member states, the US and the UK.
• China is not on the list; its export certificates do not qualify.
• Class C/D devices without listed FSC face an Indian clinical investigation.
• Class A/B devices have a lighter documentary alternative under Rule 36(5).
• Novel devices additionally need a two-year marketing history in the approving country.

2. Legal basis

The relevant provisions form a closed system: the recognised list and its exemption, the amendment that added the UK, the mandatory clinical investigation for higher-class devices from unlisted origins, the documentary alternative for lower classes, and the residual discretion for novel devices. The table below sets them out with the operative wording.

3. Expert insights

Insight one: the test is who issues the free sale certificate, not where the product is manufactured. This is the most commonly misread point. A Chinese company that sells its product to a German distributor and obtains an FSC from the German competent authority satisfies Rule 36(3). Conversely, a product manufactured in China that holds only the export sales certificate issued by the Chinese authority is outside the list. Manufacturing location, ownership of the distribution channel and brand origin are all irrelevant to the test; the issuing authority of the certificate is what decides it, and projects should document that answer before anything else.

Insight two: the price of this hurdle is time and money compounded. For Class C/D devices, Rule 36(4) means running a clinical investigation under Chapter VII (MD-22 → MD-23 permissions, with a fee of INR 100,000) before returning to the MD-14 filing. The timeline stretches from the 9-month baseline to 18 months and beyond. The clinical investigation is not only a cost centre but a planning constraint: investigator sites, ethics approvals and patient recruitment all sit outside the applicant’s direct control, and each adds variance that the original business case rarely anticipated.

Insight three: novel devices carry an additional two-year marketing history requirement. Even with a six-party approval in hand, a novel device must, under the Rule 63(1) proviso, have been on the market in the approving country for at least 2 years. A newly approved six-party product may still be required to complete a clinical investigation in India. The two clocks — the approval clock and the marketing-history clock — run separately, and only the second one qualifies the device for the relief.

Insight four: the alternative path for Class A/B is far cheaper. Under Rule 36(5), Class A/B devices need only public literature data or a country-of-origin clinical investigation plus the country-of-origin FSC. For exporters whose portfolio is concentrated in Class A/B, the real Indian hurdle is far lower than for Class C/D companies, and the portfolio should be sequenced accordingly.

4. Practical recommendations

• GRZAN’s first action for a Chinese client is not document preparation but a six-party evidence inventory: which products already hold an FSC issued by the competent authority of an EU member state, the UK, the US, Canada, Japan or Australia?
• The issuing body of each certificate is verified to be a national regulatory authority or an equivalent competent authority, not an industry association.
• Each certificate is checked for validity, and the product names and models are checked against the devices to be filed.
• Where no six-party FSC exists at all, GRZAN first discusses with the client whether it is worth obtaining a marketing status in one of the six jurisdictions first, before committing to the Indian project — for Class C/D products this upstream route is often cheaper and more controllable than an Indian clinical investigation.
• The inventory result is recorded in the project file and drives the route decision, so that the clinical investigation obligation is never discovered late.

5. Verification checklist

• □ The issuing countries of all existing FSCs have been inventoried and checked against the six-party list.
• □ Each issuing body is a national regulatory authority or an equivalent competent authority.
• □ Each FSC is within its validity period, and the product names and models match the filing.
• □ For Class C/D products without a six-party FSC, an Indian clinical investigation has been planned under Rule 36(4).
• □ For Class A/B products without a six-party FSC, public data and the country-of-origin FSC are being prepared.
• □ For novel devices, it has been verified whether the six-party marketing history reaches 2 years.

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

Regulatory information verified as of 27 October 2026.