MDR 2017's Deemed Approval Provisions — The Legal Tool Most Medical Device Companies Never Use
The Clock Is Running — How MDR 2017's Deemed Approval Provisions Can Save Your Medical Device Launch Months of Waiting
By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel
Every medical device company operating in India has experienced some version of this situation.
You file an application with CDSCO or your State Licensing Authority. You submit the documents. You pay the fee. You wait.
Weeks pass. Then months. No approval. No rejection. No communication at all.
So you wait more. You send polite follow-up emails. You make calls. You hear that the file is under review. You keep waiting.
Meanwhile your product launch is delayed. Your clinical partners are losing patience. Your investors are asking questions you cannot answer. Your competitors — many of them importers with established registrations — are selling into the market you are trying to enter.
This situation is frustrating. It is also, in many cases, legally unnecessary.
MDR 2017 contains a set of provisions that most Indian medical device companies and a significant number of regulatory consultants either do not know about or do not use strategically. These are the deemed approval provisions — rules that establish mandatory statutory timelines for regulatory decisions and specify that silence beyond those timelines constitutes approval by operation of law.
This article explains what these provisions are, where they sit in MDR 2017, and how manufacturers and importers can use them to stop waiting indefinitely for decisions that the law says should already have been made.
What Is a Deemed Approval Provision?
A deemed approval provision is a statutory rule that says: if the regulatory authority does not communicate its decision — approval or rejection — within a specified time period, the application is automatically approved.
The logic behind these provisions is accountability. Regulatory authorities process large volumes of applications with limited resources. Mandatory timelines create pressure to prioritise and decide. Deemed approval provisions ensure that the cost of regulatory delay falls on the system rather than exclusively on the applicant.
India's drugs and medical device regulatory framework has several such provisions. MDR 2017 contains at least four distinct deemed approval mechanisms that operate at different points in the licensing lifecycle. Understanding each one — and knowing when and how to invoke it — is a material competitive advantage for any medical device business operating in India.
The Four Deemed Approval Provisions in MDR 2017
Rule 26(iii) — Major Changes to Manufacturing Licence
When a licensed manufacturer wants to make a major change to their licensed product or manufacturing process — as specified in the Sixth Schedule — they must obtain prior approval from CLA or SLA before implementing the change.
Rule 26(iii) says this in full: the Central Licensing Authority or the State Licensing Authority shall indicate its approval or rejection within forty-five days and in case where no communication is received within the stipulated time from such Authority, such change shall be deemed to have been approved.
Forty-five days. If no communication is received by day forty-six, the change is legally approved.
This provision covers major changes including new indications, new materials of construction, new manufacturing sites, and significant design modifications — precisely the kinds of changes that growing medical device companies need to make as their products evolve and their businesses scale.
Rule 38(1)(v) and (vi) — Major Changes to Import Licence
The equivalent provision for import licence holders. When an authorised agent for an overseas manufacturer needs to make a major change to an imported device — new model, new indication, significant design update — prior approval from CLA is required.
Rule 38(1)(v) sets the timeline at sixty days. Rule 38(1)(vi) states that if no communication of approval or rejection is received within the stipulated time, the change is deemed approved.
Note that the import licence deemed approval timeline — sixty days — is fifteen days longer than the manufacturing licence timeline of forty-five days. Most people who know about one provision assume the other operates on the same timeline. They are different.
Rule 20(4) — Class A Manufacturing Licence Grant
Rule 20(4) requires the SLA to grant or reject a Class A manufacturing licence within forty-five days from the date of application. This is not a deemed approval provision in the same structural sense as Rule 26(iii) — it does not explicitly say "deemed approved" — but it establishes a mandatory statutory decision timeline that can be enforced through escalation and appeal mechanisms.
The critical strategic point buried in the proviso to Rule 20(4): no audit of the manufacturing site is required before the licence is granted for Class A devices. The post-grant audit by a Notified Body happens within one hundred and twenty days after the licence is issued — it does not block the licence grant.
This means a Class A manufacturer has a legal basis to expect a licence decision within forty-five days of a complete application, with no pre-licence audit requirement as a potential delay mechanism.
Rule 83(3) — Medical Device Testing Laboratory Registration
Rule 83(3) requires CLA to grant or reject registration of a medical device testing laboratory within forty-five days from the date of application. This matters for companies establishing in-house testing capabilities or for testing laboratories seeking registration to offer services to manufacturers.
Why Almost Nobody Uses These Provisions
If deemed approval provisions exist in black and white in a publicly available government gazette, why do most medical device companies not use them?
The answer is a combination of three factors.
First, most companies and their consultants have not read MDR 2017 carefully enough to know these provisions exist. The rules are detailed and dense. Most regulatory advice in India is passed down through professional networks rather than derived from primary source reading. Provisions that are not part of the standard narrative simply do not get transmitted.
Second, there is a cultural reluctance to invoke legal rights against a regulatory authority whose goodwill matters for future applications. Telling CDSCO or a State Drug Controller that their silence means your change is legally approved is not the kind of communication most Indian companies are comfortable sending. The concern about damaging a working relationship feels more immediate than the cost of waiting another few weeks.
Third, most companies lack the systematic tracking infrastructure to know when statutory deadlines have lapsed. If you are not recording the exact date of every submission and tracking it against statutory timelines, you cannot invoke deemed approval because you do not know when the clock has run out.
All three of these factors are addressable. The first requires primary source knowledge. The second requires understanding that a formally documented, professionally worded invocation of a legal provision is not aggression — it is legitimate regulatory engagement that sophisticated companies in every other jurisdiction practice routinely. The third requires a simple submission tracking system.
How to Actually Use These Provisions
The operational process for invoking a deemed approval provision has three components.
The first is precise date recording. Every application submission must be recorded with the exact date of submission — not the date of preparation, not the date of courier dispatch, but the date of confirmed receipt or online portal submission. This is the date from which the statutory clock runs.
The second is timeline monitoring. Someone in your regulatory affairs function — or your consultant — must be tracking every open application against its applicable statutory timeline. For Rule 26(iii) applications, a reminder should be set at day thirty-five. For Rule 38(1)(v) applications, at day fifty. The reminder triggers a formal written follow-up citing the application reference number, the submission date, and the applicable rule and timeline.
The third is the formal invocation letter. If the statutory deadline lapses without communication, a formal letter is sent to the authority citing the specific rule by number, stating the submission date, noting that the statutory timeline has elapsed, and formally recording that the change or application is deemed approved by operation of the cited rule as of the specific date. This letter is sent by registered post with acknowledgement. A copy is retained in your regulatory file.
The invocation letter is not a threat. It is a formal record of a legal position. If the authority subsequently attempts to require additional approvals for the change in question, this letter is your documentary defence. If an inspector queries the change during a site inspection, the deemed approval invocation letter and the registered post acknowledgement are your evidence.
The Limits of Deemed Approval
Honest practice requires acknowledging the limits of these provisions.
A deemed approval does not create a defence against a rejection that arrives on day forty-four. If CLA communicates a rejection — even an incomplete or poorly reasoned one — before the timeline lapses, the deemed approval has not been triggered. The rejection must be responded to through the application or appeal process.
A deemed approval also does not override substantive compliance requirements. If your major change application was deficient — missing documents, inadequate technical justification — a deemed approval does not make the change compliant. It creates a procedural status, not a substantive determination of compliance.
And a deemed approval is only as useful as your ability to document and defend it. An undocumented deemed approval — where you simply implemented the change after sixty days without a formal invocation letter and paper trail — is significantly harder to defend than one supported by a complete documentation record.
The Broader Point About MDR 2017 Literacy
The deemed approval provisions are one example of a broader pattern in MDR 2017. The rules contain numerous provisions — mandatory timelines, alternative pathways, waiver mechanisms, parallel processes — that create genuine strategic options for medical device companies that read the primary source carefully.
Most of these provisions are not highlighted in standard regulatory training or consultant advice. They are not secrets — they are in the public gazette — but they function as effective secrets because the vast majority of companies and consultants do not know they exist.
Primary source regulatory literacy — the ability to read MDR 2017 directly, understand its provisions in their specific textual form, and identify the strategic implications for a particular client situation — is the foundation of genuinely high-value regulatory consulting.
The companies that build this capability in-house, or work with consultants who possess it, will navigate India's medical device regulatory environment significantly faster and more effectively than those who rely on second-hand regulatory knowledge and passive waiting.
The Bottom Line
MDR 2017 gives medical device manufacturers and importers a set of legal tools to hold the regulatory system accountable to its own timelines.
Rule 26(iii) gives manufacturers forty-five days for major change approvals — after which silence is approval.
Rule 38(1)(v) and (vi) gives importers sixty days — after which silence is approval.
These tools require knowledge, systematic tracking, and professional documentation to use effectively. Most companies do not use them because they do not know they exist or lack the systems to deploy them.
That is a solvable problem.
MedReg Intel tracks regulatory developments, compliance strategy, and policy analysis relevant to India's medical device sector at medregintel.com
For regulatory consulting, strategic pathway analysis, or compliance guidance, 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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