CDSCO Will Grant Your Import Licence Without Clinical Investigation — If You Have This One Document
CE Certificate vs Free Sale Certificate — How Rule 36(3) of MDR 2017 Determines Your India Import Licence Timeline
By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel
If you are an overseas medical device manufacturer with CE marking, or an Indian authorised agent representing one, there is a provision in MDR 2017 that changes your India market entry calculation fundamentally.
It is not obscure. It is not a technicality. It is a clear, unambiguous provision in Chapter V of MDR 2017 — the chapter governing import of medical devices — that eliminates the clinical investigation requirement for devices approved in specific reference countries.
Understanding it correctly — and applying it with the right document — is the difference between a regulatory pathway measured in years and one measured in months.
The Standard Import Pathway and Its Cost
The standard pathway for importing a Class C or Class D medical device into India is demanding.
Rule 36(4) states that for devices imported from countries other than the specified reference countries, the import licence for Class C and Class D devices may be granted after safety and effectiveness has been established through clinical investigation in India as specified under Chapter VII.
Clinical investigation in India means Ethics Committee approval, CDSCO permission in Form MD-22 or MD-23, enrolled participants, safety monitoring, adverse event reporting, and a completed investigation report — before the import licence application can be considered complete.
For most devices this process can extend over multiple years depending on device complexity and investigation scope. The cost runs into crores. The complexity requires sustained regulatory management throughout.
For an overseas manufacturer evaluating the Indian market, this pathway is often the reason entry gets deferred indefinitely. The timeline is too long, the cost is too high, and the commercial return is too uncertain over that horizon.
Rule 36(3) creates a completely different pathway for devices approved in specific jurisdictions — one that eliminates the clinical investigation requirement entirely.
What Rule 36(3) Actually Says
Rule 36(3) of MDR 2017 states verbatim:
"Where a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, or the United States of America, a licence shall be granted under sub-rule (1) to the applicant without carrying out clinical investigation."
The rule is drafted in mandatory language and does not prescribe additional clinical investigation requirements beyond the free sale certificate. If a valid free sale certificate from a qualifying jurisdiction exists, there is no clinical investigation data to submit because the rule does not require it.
One important clarification before going further. Rule 36(3) removes the clinical investigation requirement. It does not remove CDSCO's authority to review the technical dossier or raise deficiencies on other grounds. A complete, well-prepared dossier remains essential. What the rule removes is one specific and significant burden — the requirement to conduct clinical investigation in India before the import licence application can proceed.
The qualifying jurisdictions are Australia, Canada, Japan, European Union Countries, and the United States of America.
Note what is not on this list. The United Kingdom. Since Brexit, the UK operates its own regulatory framework — UKCA — and is no longer an EU Country for the purposes of this provision. A UKCA-only approval does not trigger Rule 36(3). This distinction catches manufacturers who received UKCA approval expecting it to carry the same weight as a CE certificate under Indian rules.
The Document That Determines Whether This Provision Applies
This is where the practical error occurs — and understanding it correctly is critical.
The document that triggers Rule 36(3) is a free sale certificate issued by the national regulatory authority or other competent authority of an EU member state.
A CE certificate is issued by a Notified Body — a private conformity assessment organisation. It is not issued by a national regulatory authority or competent authority of an EU country. These are two different documents with different issuing authorities and different legal weight for the purposes of Rule 36(3).
A free sale certificate — also called a Certificate for Export or Certificate of Free Sale — is issued by the national competent authority of an EU member state. In Germany this is the Bundesinstitut für Arzneimittel und Medizinprodukte. In the Netherlands it is the Inspectie Gezondheidszorg en Jeugd. In France it is the Agence nationale de sécurité du médicament et des produits de santé.
These are government regulatory authorities. A free sale certificate from any of these authorities — obtained by the manufacturer from the relevant EU member state where the device is marketed — is the document that satisfies Rule 36(3).
The CE certificate remains relevant as supporting evidence of EU conformity. But the qualifying document for Rule 36(3) is the national competent authority free sale certificate. Presenting only the CE certificate and expecting it to satisfy Rule 36(3) is a document-level error that leads to deficiency notices and delays.
The practical step is to request a free sale certificate directly from the national competent authority of the EU member state where the device is marketed — and present that as the primary qualifying document in the MD-14 application.
The Two-Year Condition That Does Not Apply Here
There is a point of significant confusion in how Rule 36(3) is understood that is worth addressing directly.
Rule 63 — the provision governing investigational devices without a predicate — contains a waiver provision with a specific condition. The device must have been marketed for at least two years in the reference country before the waiver applies. The applicant must also provide pharmacovigilance data from that marketing period.
Rule 36(3) contains no such condition.
The two-year marketing requirement exists only in Rule 63. It does not appear in Rule 36(3). The provisions are in different chapters of MDR 2017, serve different regulatory purposes, and have different conditions attached to them.
A device that received CE marking recently and has a free sale certificate from an EU national competent authority can rely on Rule 36(3) today — without waiting two years and without pharmacovigilance data from the reference market.
Conflating Rule 63 conditions with Rule 36(3) requirements imposes unnecessary delay on import licence applications where those conditions simply do not belong.
What Rule 36(3) Does Not Do
Being precise about the scope of this provision matters.
Rule 36(3) eliminates the clinical investigation requirement. It does not eliminate other application requirements. The MD-14 application still requires a complete technical dossier — device description, intended use, classification basis, labelling, standards compliance, quality management system documentation, and the power of attorney from the overseas manufacturer.
The quality of the technical dossier determines whether deficiency notices are issued. Rule 36(3) removes clinical data requirements — it does not lower the standard for everything else in the dossier.
Rule 36(3) also does not create a specific accelerated timeline. Rule 36(1) gives CDSCO nine months to grant or reject an import licence application. Rule 36(3) removes the clinical investigation years that precede the application — it does not compress the nine-month decision window itself.
What it does is start that nine-month clock immediately from the date of a complete application — rather than from the end of a clinical investigation that the standard pathway requires first.
The Class A and Class B Parallel Provision
Rule 36(5) provides a related pathway for Class A and Class B devices imported from countries outside the Rule 36(3) reference list.
For these lower-risk devices from non-reference countries, the licence may be granted after safety and performance has been established through published safety and performance data or through clinical investigation in the country of origin — along with a free sale certificate from the country of origin.
Published peer-reviewed data — journals, systematic reviews, meta-analyses, post-market surveillance reports — can substitute for new clinical investigation for Class A and Class B devices. The strength of the published evidence dossier directly determines whether clinical investigation can be avoided for these device classes.
For Class A and Class B devices from non-reference countries, building the most comprehensive possible published literature package around safety and performance is the key application strategy.
The Cross-Jurisdictional Sequencing Insight
One strategic dimension of Rule 36(3) that deserves careful consideration.
UKCA approval — the UK's post-Brexit medical device regulatory pathway — is in many categories faster and less resource-intensive to obtain than US FDA clearance. The MHRA has processed UKCA applications efficiently and the technical requirements for many device categories are well-defined.
However, UKCA alone does not trigger Rule 36(3) because the UK is no longer an EU country.
The sequencing insight is this. A manufacturer who obtains UKCA approval first has already completed most of the technical work required for CE marking under EU MDR 2017/745. The delta between UKCA-ready documentation and CE-ready documentation is smaller than building a CE submission from scratch.
Obtaining UKCA first — for UK market access and regulatory readiness — and then pursuing CE marking specifically to generate an EU national competent authority free sale certificate creates a three-jurisdiction regulatory sequence with a clear commercial logic.
UKCA for speed and UK access. CE for EU access and India Rule 36(3) eligibility. MD-14 with EU national competent authority free sale certificate for India import licence without clinical investigation.
Each step builds on the previous one. Each step opens a market. The India pathway is unlocked as a consequence of the CE marking step rather than requiring a separate India-specific clinical programme.
What This Means for India Market Entry Decisions
If you hold CE marking and a free sale certificate from an EU national competent authority, your India regulatory pathway is fundamentally different from the standard clinical investigation route.
The clinical investigation requirement — the provision that makes the standard pathway extend over multiple years — does not apply to your device under Rule 36(3). Your pathway to an Indian import licence runs through a complete MD-14 technical dossier, the correct qualifying document, and a valid Indian authorised agent.
The nine-month CDSCO decision window under Rule 36(1) is your realistic regulatory timeline — not the multiple years the standard pathway implies.
For manufacturers who have been evaluating India market entry and finding the regulatory pathway prohibitive, Rule 36(3) changes the picture materially. The question is not whether you can afford the India regulatory pathway. The question is whether you have the right document and a complete dossier.
The Bottom Line
Rule 36(3) of MDR 2017 is drafted in mandatory language and eliminates the clinical investigation requirement for medical devices holding free sale certificates from Australia, Canada, Japan, EU Countries, or the USA.
It contains no two-year marketing requirement — that condition exists only in Rule 63 and does not apply here.
The qualifying document is a free sale certificate from a national competent authority of an EU member state — not the CE certificate issued by a Notified Body. Obtaining the correct document and building the MD-14 dossier around it is the foundation of a successful Rule 36(3) application.
India is a USD 11 billion medical device market growing at 12 to 15 percent annually. For CE-marked devices, the regulatory pathway to that market is shorter than the standard narrative suggests.
MedReg Intel tracks regulatory developments, compliance strategy, and policy analysis relevant to India's medical device sector at medregintel.com
For import licence strategy, technical dossier preparation, or regulatory pathway analysis, reach out at ankur@medregintel.com
Ankur Khare is a Biomedical Engineer and Regulatory Affairs Specialist and the founder of MedReg Intel. This article is for informational purposes and does not constitute formal regulatory or legal advice.
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