The Wait That Never Needed to Happen — Rule 36(3) Has No Two-Year Marketing Requirement
The Two-Year Myth — Why Manufacturers Are Waiting Unnecessarily Before Filing Their India Import Licence Application
By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel
There is a piece of advice circulating in Indian MedTech regulatory circles that is costing manufacturers months — sometimes years — of unnecessary delay.
The advice sounds reasonable. It is delivered confidently. It is repeated by experienced practitioners who genuinely believe it is correct.
It is wrong.
The advice is this: before filing your MD-14 import licence application in India under the free sale certificate pathway, your device needs to have been marketed in the reference country for at least two years.
Manufacturers hear this and wait. They wait through their first year of EU or US marketing. They wait through their second year. They file their India application in year three — two years after they could have filed.
Two years of Indian market access lost. Two years of revenue not generated. Two years of clinical relationships not built. Two years of competitive positioning not established.
All because of a conflation between two separate provisions of MDR 2017 that have different conditions and different scopes — and because almost nobody has taken the time to read both provisions carefully enough to notice the difference.
This article does that reading. And the difference is significant.
The Two Provisions — Rule 36(3) and Rule 63
MDR 2017 contains two separate provisions that allow overseas manufacturers to avoid or reduce clinical investigation requirements in India by relying on foreign regulatory approvals.
They are Rule 36(3) and Rule 63(1) fourth proviso.
They are not the same provision. They do not have the same conditions. They do not apply to the same applications. And critically — only one of them has a two-year marketing requirement.
The confusion between them is the source of one of the most expensive and widespread regulatory myths in Indian MedTech.
Rule 36(3) — What It Actually Says
Rule 36(3) of MDR 2017 states:
Where an application is made for grant of licence to import a medical device or investigational medical device which has been approved for marketing by a reference regulatory authority from Australia, Canada, Japan, EU Countries or United States of America, then, a licence shall be granted without carrying out clinical investigation in India.
Read that provision carefully. Every word matters.
"A licence shall be granted" — mandatory language. Not discretionary. Not subject to additional conditions. Shall.
"Without carrying out clinical investigation in India" — the clinical investigation requirement is eliminated entirely.
"Which has been approved for marketing by a reference regulatory authority" — the condition is approval for marketing. Not two years of marketing. Not post-market data. Not a minimum marketing duration. Approval for marketing.
That is it. That is the complete provision.
There is no two-year marketing requirement in Rule 36(3). There is no minimum marketing duration. There is no post-market data requirement. There is no condition beyond approval for marketing by a reference regulatory authority and the submission of a qualifying free sale certificate.
A device approved for marketing in the EU yesterday — with a free sale certificate obtained from BfArM today — is eligible for Rule 36(3) treatment in India today.
Rule 63(1) Fourth Proviso — Where the Two-Year Requirement Actually Lives
Rule 63 of MDR 2017 governs the grant of permission to market investigational medical devices — devices without an Indian predicate that require a new device permission rather than an import licence.
Rule 63(1) fourth proviso states that where the device "has been marketed for two or more years" in a reference country, the CLA may abbreviate, defer, or omit the clinical investigation requirement.
This is the provision that contains the two-year marketing requirement.
Note what Rule 63 governs — new device permission applications, filed in Form MD-26. These are applications for devices that require marketing permission because they have no Indian predicate and are being evaluated as new investigational devices.
Rule 63 does not govern import licence applications. It does not modify Rule 36(3). It does not add conditions to the Rule 36(3) pathway. It operates in a completely separate part of MDR 2017 — Chapter VIII, governing investigational devices — while Rule 36(3) operates in Chapter V, governing import licences.
The two-year marketing requirement in Rule 63 applies to MD-26 applications for new device permission.
It does not apply to MD-14 applications for import licence.
How the Conflation Happens
Understanding why this conflation is so widespread requires understanding how most Indian regulatory advice is transmitted.
Most regulatory guidance in India is not derived from careful primary source reading of MDR 2017. It is transmitted through practitioner networks — consultant to consultant, senior to junior, experienced professional to newer entrant. Each transmission introduces the possibility of a simplification or a misremembering.
Somewhere in this transmission chain the two-year marketing requirement from Rule 63 became attached to Rule 36(3) applications. The most likely mechanism is this: a practitioner advising on a Rule 63 application learned the two-year condition. When subsequently advising on a Rule 36(3) application — a different provision but superficially similar in that both involve reference country approvals — the two-year condition was applied by analogy.
The analogy is wrong. But once it entered the advice-giving network it was reinforced by repetition. Practitioners who received the wrong advice gave the same wrong advice to the next generation of clients. The myth propagated.
The result is an industry-wide assumption that Rule 36(3) requires two years of marketing when the provision itself contains no such requirement.
The Commercial Implication — Quantified
The commercial implication of this conflation is specific and measurable.
Consider a European manufacturer who received CE marking and a BfArM free sale certificate in January 2024. Acting on advice that two years of EU marketing was required before filing in India, they planned their MD-14 application for January 2026.
Under the correct reading of Rule 36(3) — which has no two-year requirement — they could have filed their MD-14 application in February 2024, one month after receiving their free sale certificate. With a nine-month review timeline under Rule 36(1), they could have received their Indian import licence in November 2024.
Instead they filed in January 2026. They will receive their licence in October 2026 at the earliest.
The delay — attributable entirely to the two-year myth — is approximately 23 months of Indian market access. For a device with meaningful Indian market potential that delay represents crores of foregone revenue and competitive ground ceded to manufacturers who either knew the correct reading or got lucky with their advice.
The Qualifying Document — A Second Source of Confusion
The two-year myth is not the only source of confusion around Rule 36(3). There is a second, related error that compounds the damage — the CE certificate versus free sale certificate confusion.
Rule 36(3) requires a free sale certificate from a reference regulatory authority. The reference regulatory authority for EU approvals is the national competent authority of an EU member state — BfArM in Germany, IGJ in Netherlands, ANSM in France, AIFA in Italy.
A CE certificate is not issued by a national competent authority. It is issued by a Notified Body — a private conformity assessment organisation. A CE certificate is evidence that a device conforms to EU MDR requirements. It is not a free sale certificate from a reference regulatory authority.
These are two different documents from two different types of organisations with two different legal statuses.
The most common Rule 36(3) application error is submitting a CE certificate instead of a free sale certificate. CDSCO rejects the application. The manufacturer regroups. More months lost.
The correct sequence for an EU-approved device seeking Rule 36(3) treatment in India:
One — obtain CE marking from a Notified Body.
Two — apply to the national competent authority of an EU member state for a free sale certificate.
Three — wait for the free sale certificate — typically two to eight weeks depending on the authority.
Four — file MD-14 application citing Rule 36(3) with the free sale certificate enclosed.
Step two is the step most manufacturers and some advisors skip or misunderstand. The CE certificate alone is not sufficient. The free sale certificate from the national competent authority is the qualifying document.
The Correct Reading — Applied to Real Scenarios
Scenario 1 — Device approved in EU for three months
A Class IIb orthopaedic implant received CE marking under EU MDR 2017/745 three months ago. The manufacturer obtained a free sale certificate from BfArM two months ago.
Correct application of Rule 36(3): file MD-14 immediately. No two-year wait. No additional clinical data required. Clinical investigation in India eliminated. Nine-month review timeline from complete application.
What most manufacturers are told: wait two more years before filing. Incorrect.
Scenario 2 — Device approved in US with FDA clearance
A Class II diagnostic device received FDA 510(k) clearance six months ago. The manufacturer obtained a letter from FDA confirming marketing clearance which can serve as evidence of approval for marketing by a reference regulatory authority.
Correct application of Rule 36(3): file MD-14 immediately citing the FDA clearance letter as evidence of reference country approval. No two-year wait. Clinical investigation eliminated.
What most manufacturers are told: wait eighteen more months before the two-year requirement is satisfied. Incorrect.
Scenario 3 — Device has no reference country approval
A novel Class C diagnostic device has no approval in any reference country. The manufacturer is developing it for simultaneous global launch.
Rule 36(3) does not apply. No free sale certificate from a reference country exists. The relevant pathway is Rule 63 — and here the two-year marketing requirement in Rule 63(1) fourth proviso genuinely applies if and when the manufacturer obtains reference country approval and wants to use that approval to support a waiver in a Rule 63 MD-26 application.
This is the correct application of the two-year requirement — in Rule 63 MD-26 applications, not in Rule 36(3) MD-14 applications.
A Note on Regulatory Practice Versus Statutory Text
It is important to be transparent about the gap between statutory text and operational practice.
This article argues the correct reading of Rule 36(3) based on the statutory text of MDR 2017 as gazetted. The statutory text contains no two-year marketing requirement for Rule 36(3) applications.
However CDSCO's operational practice — how applications are actually processed by specific officers on specific days — may not always align with the statutory text. If a CDSCO officer applies an unofficial two-year requirement to a Rule 36(3) application, the statutory argument in this article is the basis for a formal objection and if necessary an appeal.
The argument must be made in writing, citing Rule 36(3) specifically, and distinguishing it explicitly from Rule 63(1) fourth proviso. A well-documented position that cites the specific statutory language and explicitly addresses the distinction between the two provisions is significantly more defensible than a verbal representation.
This is why the quality of the written application and the accompanying legal argument matters as much as the strategic pathway decision itself.
What This Means for Your India Strategy
If your device has reference country approval and a qualifying free sale certificate from a national competent authority — file your MD-14 application now.
Not when two years of marketing have passed. Not when your post-market data accumulates. Not when your advisor tells you the time is right.
Rule 36(3) does not require two years. It requires approval for marketing. If you have that approval and the qualifying free sale certificate — you have everything Rule 36(3) requires.
If your device has reference country approval but only a CE certificate and no free sale certificate — obtain the free sale certificate from the relevant national competent authority first. BfArM, IGJ, or ANSM for EU approvals. This takes two to eight weeks in most cases. Then file.
If you are currently waiting because an advisor told you to wait two years — this article is the basis for a conversation with that advisor. Ask them to cite the specific provision of MDR 2017 that imposes the two-year requirement on Rule 36(3) applications. If they cannot cite it — because it does not exist in Rule 36(3) — the wait is over.
The Bottom Line
Rule 36(3) of MDR 2017 eliminates clinical investigation for devices with reference country approval. Its condition is approval for marketing. There is no two-year marketing requirement in Rule 36(3).
The two-year marketing requirement exists in Rule 63(1) fourth proviso — a completely separate provision governing MD-26 new device permission applications, not MD-14 import licence applications.
The conflation of these two provisions has caused manufacturers across the Indian MedTech industry to wait unnecessarily before filing applications they could have filed on the day they received their free sale certificate.
That wait ends when you read the rule.
MedReg Intel tracks regulatory developments, compliance strategy, and policy analysis relevant to India's medical device sector at medregintel.com
If you have been waiting before filing your MD-14 application because you were told a two-year marketing period is required — reach out at ankur@medregintel.com before waiting any longer.
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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