Your Device Can Be in Indian Hospitals in 30 Days — While Your Full Licence Application Is Still Pending
The Test Licence Strategy — How Rules 31 and 40 Get Any Medical Device Legally Into India in 30 Days While Your Full Licence Application Runs in Parallel
By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel
There is a regulatory pathway in MDR 2017 that most MedTech founders and their advisors treat as a minor administrative tool.
It is not a minor administrative tool.
It is a commercial strategy that converts the most expensive period in a medical device company's India journey — the regulatory waiting period — from dead time into productive time.
The pathway is the test licence. The timeline is 30 days. The opportunity is the 9 to 12 months between deciding to enter India and receiving a full commercial licence — a period that most companies spend waiting when they could be building the clinical relationships, generating the early performance data, and training the key opinion leaders that determine whether their commercial launch succeeds or struggles.
This article explains exactly how the test licence works, what you can and cannot do under it, and how running it in parallel with your full licence application changes your India market entry strategy fundamentally.
What the Test Licence Actually Is
MDR 2017 provides two distinct test licence pathways — one for domestic manufacturers and one for importers.
For domestic manufacturers — Rule 31
Rule 31(1) states that small quantities of Class A, B, C, or D medical devices may be manufactured for the purpose of clinical investigations, test, evaluation, examination, demonstration, or training — for which an application shall be made in Form MD-12 to the Central Licensing Authority.
Rule 31(3) states that CLA shall grant a test licence in Form MD-13 within 30 days from the date the application is made.
Thirty days. Any device class. Any purpose within the specified list. No pre-grant inspection. No QMS audit. No site verification before the licence is in your hands.
For importers — Rules 40 and 41
Rule 40(1) states that notwithstanding anything contained in these rules, any medical device or in vitro diagnostic medical device may be imported for the purpose of clinical investigations, test, evaluation, demonstration, or training.
Rule 41(1) states that CLA shall grant a test import licence in Form MD-17 within 30 days from the date of application.
Again — thirty days. Any device class. Any IVD. For any of the specified purposes.
Both licences carry a validity of three years from the date of issue under Rule 31(5) and Rule 41(5) respectively.
Three years of legal device presence in India — for demonstration, clinical relationships, data generation, and training — starting from day 30 of your decision to enter the Indian market.
The 30-Day Timeline — What the Law Actually Says
The 30-day timelines for both test licences are statutory obligations on the Central Licensing Authority — not aspirational targets.
Rule 31(3) says CLA "shall grant" the licence within 30 days — or reject with reasons recorded in writing. Rule 41(1) uses identical mandatory language.
The practical implication is the same as every other statutory timeline in MDR 2017. Track your submission date precisely. At day 25 send a formal written follow-up to CLA citing the application reference, the submission date, and the applicable rule and mandatory timeline. If day 30 passes without communication escalate formally. Do not wait indefinitely.
A test licence that arrives on day 45 instead of day 30 because nobody tracked the statutory deadline is 15 days of clinical relationship building lost unnecessarily.
The statutory timeline is your right. Exercise it.
What You Can Do Under a Test Licence
This is the section that changes the commercial calculus of India market entry.
Under a valid test import licence or test manufacture licence the following activities are legally permitted — and each one has direct commercial value.
Hospital demonstrations
You can legally bring your device into Indian hospitals and demonstrate it to clinical teams, procurement committees, and department heads. This is the most direct commercial activity permitted under a test licence — and it is the activity that most determines whether hospitals will purchase when your commercial licence arrives.
A hospital that has seen your device demonstrated, evaluated its performance in their environment, and discussed its clinical applications with your team is a fundamentally different commercial prospect than a hospital that receives a sales call on the day your commercial licence arrives. The test licence period is the relationship-building period. Most companies waste it.
Clinical investigation
If you obtain MD-22 or MD-23 permission from CLA under Rule 51 — the test licence provides the legal basis for the devices to be present in India during the investigation. The test licence and the clinical investigation permission work together. You cannot conduct a clinical investigation without one — and most companies apply for the investigation permission before securing the test licence, adding sequential delays that parallel filing eliminates.
Test and evaluation
You can conduct formal performance testing and evaluation of your device in Indian clinical conditions. This generates real-world data from Indian patients, Indian clinical environments, and Indian infrastructure conditions — data that strengthens your full licence application, supports your clinical evaluation report, and provides evidence for any Rule 63 waiver application.
Training
Clinical staff training is explicitly permitted under the test licence. Training nurses, biomedical engineers, and clinicians to use your device before your commercial licence arrives means your commercial launch does not face the 3 to 6 month learning curve that delays revenue generation for most medical device launches.
Key opinion leader engagement
KOL development — building relationships with the leading clinicians in your device category — is one of the most commercially valuable activities in medical device market entry. It cannot be done effectively from outside India. A test licence gives you the legal basis to be in India, in hospitals, with your device, building these relationships over months rather than starting from zero on the day your commercial licence arrives.
What You Cannot Do — The Critical Limitation
The test licence has one significant and non-negotiable limitation.
Commercial sale is not permitted.
Rule 32(a) states that the test manufacture licencee shall use the device exclusively for the purposes of clinical investigations, test, evaluation, examination, demonstration, or training at the place specified in the licence.
Rule 41(2) states that the test import licencee shall use the device exclusively for the specified purposes and not for commercial sale.
A device imported or manufactured under a test licence cannot be sold. It cannot be transferred to a hospital for use in routine patient care outside of the approved purposes. It cannot be invoiced commercially.
Rule 41(6) adds an important practical provision — medical devices imported under a test licence that are not used may be permitted to be exported or destroyed under intimation to CLA. They cannot simply be retained indefinitely or converted to commercial stock when the full licence arrives.
Understanding this limitation clearly is important for two reasons.
First — it prevents compliance violations that could damage your full licence application. A company that sells devices under a test licence has not just violated the test licence conditions — it has potentially violated Section 18 of the Drugs and Cosmetics Act which governs sale of devices without a licence. The consequences are serious.
Second — it frames the test licence period correctly as a relationship building and data generation period rather than a soft launch. The commercial value of the test licence is not in the devices used during the period — it is in the relationships, data, and clinical adoption that the period generates for the commercial launch that follows.
The Parallel Pathway — The Strategic Core
This is the insight that most companies miss entirely.
The conventional approach to India market entry is sequential.
Decision to enter India → Full licence application filed → Wait 9 to 12 months → Licence arrives → Begin hospital demonstrations → Build clinical relationships → Revenue starts arriving 6 to 12 months after licence grant.
Total time from decision to meaningful revenue: 18 to 24 months minimum.
The parallel pathway approach is different.
Day 1 — Full licence application filed. MD-14 for import or MD-3 for manufacturing. Day 1 simultaneously — Test licence application filed. MD-16 for test import or MD-12 for test manufacture. Day 30 — Test licence arrives. Hospital demonstrations begin. Clinical relationships start. KOL engagement starts. Performance data generation starts. Staff training begins. Month 9 to 12 — Full commercial licence arrives. Commercial sales begin immediately — into hospitals that already know your device, into clinical teams that are already trained, with KOL endorsements already established.
Total time from decision to meaningful revenue: 9 to 12 months — the commercial licence period only. The relationship building that would have taken 6 to 12 months after commercial licence grant has already happened during the waiting period.
The parallel pathway does not compress the regulatory timeline. The full licence still takes 9 to 12 months. What it compresses is the time between licence grant and meaningful commercial revenue — because the groundwork has already been laid.
That compression is worth months of runway and multiple percentage points of post-launch revenue trajectory.
The Dual Test Licence Strategy for Domestic Startups
For Indian MedTech startups the parallel pathway has an additional dimension.
Rule 31 provides a test manufacture licence for prototype manufacturing and early device production. Rule 40 and Rule 41 provide a test import licence for importing reference devices, components, or comparison products.
Both can run simultaneously.
A startup developing a novel Class C diagnostic device can use Rule 31 to manufacture small quantities of their device prototype legally — for clinical investigation, demonstration, and evaluation — while simultaneously using Rule 40 to import the international reference device or predicate device for comparison testing and clinical benchmarking.
This dual test licence approach gives a domestic startup the maximum possible legal flexibility during their development and pre-commercialisation phase.
They can manufacture their own device legally. They can import comparison devices legally. They can demonstrate both to investors, clinical partners, and procurement committees. They can generate comparative performance data that strengthens their substantial equivalence argument under Rule 51(5) or their waiver application under Rule 63(1).
All of this is legal. All of it starts within 30 days. None of it requires a full commercial licence.
Most domestic startups either do not know the test manufacture licence exists or treat it as a clinical investigation tool only. It is a development stage commercial strategy tool with a 30-day activation timeline and a 3-year operational window.
The Clinical Investigation Connection
There is a specific sequencing mistake that costs MedTech companies months of delay — and the test licence is the fix.
The mistake is this: a company applies for clinical investigation permission in Form MD-22 under Rule 51 and then realises they need a test licence for the investigational devices to be legally present in India during the investigation. The test licence application is filed after the MD-22 application. Both applications proceed sequentially. The clinical investigation cannot begin until both are granted — and the company has added 30 days of sequential delay that parallel filing would have eliminated.
The correct approach is to file the test licence application simultaneously with or before the MD-22 application. Since the test licence is granted in 30 days and the MD-22 clinical investigation permission takes 90 days — the test licence will arrive first. When the MD-22 permission arrives the test licence is already in place. The clinical investigation can begin immediately on the day permission is granted.
This single sequencing insight — filing test licence and clinical investigation permission simultaneously rather than sequentially — saves 30 days of clinical investigation delay on every programme.
At the cost of drug and device clinical programmes in India, 30 days saved is a meaningful commercial and financial outcome.
The Investor Conversation This Changes
Regulatory timeline is one of the three primary risk factors that medical device investors assess when evaluating an investment. The other two are clinical evidence and commercial traction.
A startup that enters an investor meeting with the following position is fundamentally different from one that does not.
We applied for our full import licence 8 months ago. While waiting we obtained a test import licence in 30 days. We have demonstrated our device at 12 hospitals. We have generated preliminary performance data from 200 patients in Indian conditions. We have trained clinical teams at 4 major centres. We have letters of intent from 3 procurement committees. Our commercial licence is expected in the next 60 days — and we will launch into a market that already knows us.
Compare this to the startup that applied for their full licence 8 months ago and has been waiting.
Same regulatory timeline. Completely different commercial position. The difference is the test licence parallel strategy.
Investors are not funding regulatory applications. They are funding commercial outcomes. A startup that has used the regulatory waiting period to build commercial infrastructure has de-risked the investment in a way that no additional clinical data or technical demonstration can replicate.
What This Means for Your India Market Entry Strategy
The test licence parallel strategy has three practical implications for any company evaluating India market entry.
First — file your test licence application on the same day as your full licence application. Not after. Not when you think about it later. The same day. The incremental cost and administrative burden is minimal. The commercial value of 30-day access versus 9-month wait is enormous.
Second — design your test licence period as a commercial programme not a regulatory formality. Define which hospitals you will demonstrate at. Define what performance data you will generate. Define which KOLs you will engage. Define what training you will deliver. Treat the test licence period as your pre-commercial launch — because that is what it is.
Third — connect your test licence strategy to your full licence dossier. The performance data generated during your test licence period strengthens your technical dossier. The clinical relationships established during the period generate the investigator network for your clinical investigation. The KOL engagement generates the clinical evidence letters that support your Rule 63 waiver application. The test licence period is not separate from your regulatory strategy — it is part of it.
The Bottom Line
Rule 31 and Rules 40 and 41 of MDR 2017 create a 30-day legal pathway into India for any medical device — for demonstration, clinical investigation, evaluation, and training.
The test licence is valid for 3 years. It covers any device class. It can run in parallel with any full licence application. And it converts the most expensive dead time in India market entry — the regulatory waiting period — into productive commercial time.
Most companies treat this pathway as a clinical investigation tool. It is a commercial strategy.
The 30-day timeline is statutory. The 3-year validity is generous. The commercial sale restriction is real and must be respected. The opportunity to build clinical relationships, generate performance data, and train clinical teams before your commercial licence arrives is available to every medical device company entering India.
Almost none of them use it.
MedReg Intel tracks regulatory developments, compliance strategy, and policy analysis relevant to India's medical device sector at medregintel.com
If you are planning India market entry and have not yet filed a test licence application alongside your full licence application — reach out at ankur@medregintel.com before your full application reaches the 3-month mark.
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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