India now allows eligible medical devices approved in the European Union to be considered for a waiver from submitting clinical investigation results in India. The change was made through G.S.R. 744(E) and published on 19 August 2026. It matters for devices with no predicate device in India. An eligible device of this kind may qualify for a waiver of the clinical investigation requirement. EU recognition under India medical device regulations is not automatic approval. Each application is still decided by the Central Drugs Standard Control Organization (CDSCO).
This article explains what changed, who may benefit, how the waiver works and what you still have to do.
What Is EU Recognition Under India Medical Device Regulations?
India has recognized the European Union in one place only, the fourth proviso to Rule 63(1). It has not swapped its own requirements for the EU system. The EU medical device regulations do not apply in India. The Medical Devices Rules 2017 still govern.
CDSCO is India’s national regulator for medical devices. It works under the Directorate General of Health Services.
India sorts devices into four risk classes, A to D. Class A carries the lowest risk and Class D the highest. For imports, the authority in all four classes is the Central Licensing Authority (CLA), which means the Drugs Controller General of India.
In short, EU status may support the Rule 63 waiver, but the manufacturer still has to meet every other Indian requirement.
What Changed in 2026 for EU Medical Devices
India has expanded recognition of the European Union within a specific provision under Rule 63. The change is small.
Notification: G.S.R. 744(E), the Medical Devices (Third Amendment) Rules, 2026. It is dated 14 August 2026 and was published in the Gazette of India on 19 August 2026 (Gazette No. 678). It follows a draft published on 10 April 2026.
What it changed: Rule 5 of the notification adds “or European Union countries” after “or Japan” in the fourth proviso to Rule 63(1).
In force from: the date of final publication in the Official Gazette (Rule 1(ii)). The notification has no transition period.
Why: the Ministry’s stated aims are simpler regulatory processes, lower costs, more transparency and predictability, and timely availability of advanced devices. It also expects less regulatory burden and shorter timelines for importers and manufacturers.
Rule 63 names the countries whose approvals can support this waiver. The EU is now on that list, next to the UK, the United States, Australia, Canada and Japan. The Ministry’s press release of 24 August 2026 calls them “recognized stringent regulatory jurisdictions”.
CDSCO EU recognition is therefore a four-word addition to an existing rule, not a new route. The Ministry says eligible EU-approved devices can now use the waiver. “Eligible” is the key word. The device must still meet the waiver’s conditions, such as two years on the EU market.
The same notification also makes small changes to other rules, including those for Class A devices that are non-sterile and non-measuring. None of them affects the waiver.
A separate notification of the same date, G.S.R. 743(E), changes labelling for sterile devices. If a manufacturer has another licensed company sterilise its device, the label must show that company’s sterilisation licence number. This becomes mandatory six months after the notification date. The same notification also sets fees for testing devices. If your device is sterile, check whether this label rule applies to you.
Clinical Investigation Waiver in India for EU Devices
EU recognition may let an eligible device skip submitting Indian clinical investigation results. But because the clinical investigation waiver in India depends on conditions, it is not universal.
To understand when the waiver applies, it helps to first consider the usual requirement. A device with no predicate is an “investigational medical device” and its Form MD-26 application normally follows a clinical investigation. Rule 63 contains other provisos too, and they should not be confused with the foreign-approval waiver.
- Animal or clinical data may be abbreviated, deferred or omitted for life-threatening conditions, urgent needs and similar cases.
- For Class A investigational devices, clinical data may not be required unless the CLA records a reason.
The foreign-approval proviso works differently. Results of a clinical investigation may not need to be submitted where all of these conditions hold.
- The device is approved by the regulatory authorities of a listed jurisdiction.
- It has been marketed there for at least two years.
- The CLA is satisfied with the safety, performance and pharmacovigilance data.
- There is no evidence or theoretical possibility of a difference in behaviour or performance in the Indian population.
- The applicant gives a written undertaking to run a post-marketing clinical investigation under a CLA-approved protocol.
Anyone claiming the waiver must submit supporting data with the application (Fourth Schedule, Part IV). The amendment did not change the conditions. It also does not mention CE marking. As of 7 October 2026, neither the gazette nor CDSCO’s published documents explain what “approved by the regulatory authorities” means for an EU device. Confirm with CDSCO how it treats your EU certificate before you rely on the waiver.
One more distinction. Do not confuse the waiver with the ordinary import licence. Under Rule 36, the import licence already accepts free sale certificates from EU countries, with no clinical investigation. Devices without a predicate cannot use that route. They need Form MD-27 permission first.
CE Marking for Medical Devices in India
No, CE marking does not approve a device in India. It is evidence of European conformity, and nothing more than that in the Indian system.
Under the EU Medical Device Regulation, the manufacturer must first show that the device meets the rules. A Declaration of Conformity is then drawn up. Only after that can the CE mark go on the device. By issuing the declaration, the manufacturer takes responsibility for compliance with the Regulation.
Most devices also need a notified body. This is an independent organisation, designated under the Regulation, that checks the device and its documents. Class I devices are an exception, because the manufacturer generally carries out the conformity check alone.
Indian market access rests on the Medical Devices Rules 2017. An overseas manufacturer must work through an authorised agent in India. The agent applies for an import licence on the manufacturer’s behalf. If the device has no predicate, the agent first applies for permission, using Form MD-26.
So EU medical device approval in India is never automatic. EU approved medical devices in India still need Indian authorization before they are imported and sold. EU evidence may support the file where an Indian provision allows it, yet CDSCO approval for EU medical devices remains a decision for the CLA.
EU Documents That Support an Indian Application
Several EU documents can support an Indian application, but India’s rules decide which documents are required. The list depends on the route and the device.
For devices without a predicate, the legal list is in Part IV of the Fourth Schedule. The Form MD-26 checklist shows what CDSCO expects in practice. Both ask for design, risk, biocompatibility, clinical or waiver data, regulatory status in other countries and labelling. The table below shows where EU documents can help.
| EU document |
Where it fits in the Indian requirement
|
| Certificates and approval evidence |
Part IV item 7 (regulatory status). The MD-26 checklist asks for a notarized approval letter
|
| Free Sale Certificate |
Used for the ordinary import licence (Rule 36). Not listed in Part IV or the MD-26 checklist
|
| EU Declaration of Conformity |
Not named in Part IV or the checklist
|
| Technical documentation, test reports and risk management file |
Part IV items 1 and 3. Checklist sections 6 and 8
|
| Clinical evaluation and post-market data |
Part IV items 5 and 6. Checklist items 13 to 15
|
| ISO 13485 certificate |
Not named in Part IV or the MD-26 checklist
|
CDSCO’s Form MD-26 checklist does not yet mention the EU. As of 15 October 2026 it names the UK, the US, Australia, Canada and Japan, followed by “etc.” It does not yet mention the EU. But rule 63 now does name the EU.
In practice, manufacturers often assume a strong European technical file can be moved straight into an Indian submission. It rarely works that way. Map the Indian requirements first, then decide which European evidence can be reused, supplemented or reformatted. If CDSCO’s checklist has not caught up with the amended rule, say so in your cover letter.
Which EU Medical Devices Can Benefit
Only devices that meet the Rule 63 conditions can benefit from EU recognition, and eligibility has to be judged under Indian law. Start with these factors.
- Indian classification, which follows the intended purpose of the device (First Schedule)
- Predicate status
- Regulatory approval status in the EU
- The Rule 63 conditions, including two years of marketing
- Clinical evidence and intended use
- Any other condition in the current Rules
A predicate device is the first and first-of-its-kind device approved by the CLA, with similar intended use, materials and design. Being first in Europe does not decide the question.
CDSCO Approval for EU Medical Devices Step by Step
EU manufacturers can reach the Indian market in eight steps, taken in this order.
Step1: Confirm the Indian classification. The CLA classifies by intended use and the First Schedule, and the class-wise list is published on the CDSCO website. Do not copy the EU class.
Step 2: Choose the route. Check predicate status, EU status and Rule 63 eligibility. Class A non-sterile, non-measuring devices follow a registration route instead of a licence.
Step 3: Appoint the authorised agent. The agent is appointed by power of attorney. An agent holding a manufacturing or wholesale licence, or a Form MD-42 registration certificate, applies for the import licence in Form MD-14 through the online portal. For Form MD-26 the agent applies in case of import. Sale and distribution licences are a separate State matter.
Step 4: Prepare the dossier. Follow Part IV of the Fourth Schedule and the MD-26 checklist. Add labelling and post-market information.
Step 5: Submit the application. For devices without a predicate this is Form MD-26. Confirm the current portal and form requirements with CDSCO.
Step 6: Answer CDSCO queries. CLA has 120 days, extendable by up to 30. If CDSCO asks for information, reply within 90 days or risk rejection. The rule does not promise approval in that time.
Step 7: Obtain permission and licence. Form MD-27 permission comes before the import licence. Imported devices need the import licence number, importer name and address, actual manufacturing address and manufacture date on the label. These can be added by stickering where not already printed.
Step 8: Meet post-market duties. These are specific.
- MD-27 holders must inform CDSCO of the launch date. They submit Periodic Safety Update Reports every six months for the first two years from launch, then annually for two more years. Suspected unexpected serious adverse events go to CDSCO within fifteen days of awareness.
- Import licence holders have a fifteen-day deadline. CDSCO must be told within fifteen days if a device is withdrawn, restricted or cancelled overseas. Recall directions from the CLA must be followed. Major changes need prior approval.
- Recall applies when a device may be unsafe. The manufacturer or authorised agent must act at once. The competent authority must also be informed.
- Manufacturer systems must cover complaints and adverse events. Complaints are handled under documented procedures, and adverse events are reported to the regulatory authority.
Common Mistakes by EU Manufacturers
Most problems with EU recognition in India come from treating it as a shortcut. These are the mistakes seen most often.
- Treating CE marking as Indian approval
- Assuming every EU-approved device gets the waiver
- Using the EU class without checking Indian classification
- Skipping the predicate assessment
- Submitting incomplete technical documentation
- Ignoring Indian labelling rules
- Underestimating Indian post-market duties
- Treating the Indian file as a simple copy of the EU file
Conclusion
EU recognition under India medical device regulations is an important facilitation, not automatic Indian market authorization.
The process runs in six stages. First, the EU regulatory status is established. Next, the device is assessed against India’s eligibility rules, including Rule 63. If the waiver applies, that route is chosen and the application is prepared. The application is then submitted to CDSCO. Once Indian authorization is granted, the device may be imported. Post-market duties begin when it reaches the market.
Rule 63 now names the EU, so your existing EU evidence may be enough to skip a local clinical investigation. The first step is to test your device against the waiver’s conditions.
Planning to bring an EU-approved device to India? Artixio can help review your regulatory documents and shape your Indian market-entry plan. Explore our India MedTech regulatory services for medical device compliance and registration support or write to info@artixio.com.
FAQs
Q1. Does India recognize EU approval for medical devices?
Only in a limited way. India has recognized the European Union within one Rule 63 provision, and EU regulatory status is not Indian authorization.
Q2. Is CE marking enough to sell a medical device in India?
No. CE marking does not replace the Indian import licence or permission process under the Medical Devices Rules 2017.
Q3. Can an EU-approved medical device avoid clinical investigation in India?
Possibly. The Rule 63 proviso can waive submission of clinical investigation results for eligible devices without predicates, if every prescribed condition is met.
Q4. What changed in India’s medical device regulations in 2026?
G.S.R. 744(E) inserted “or European Union countries” into the fourth proviso to Rule 63(1). It was notified on 14 August 2026 and published in the Gazette on 19 August 2026.
Q5. What documents does an EU manufacturer need for CDSCO approval?
That depends on the route and the device. For devices without a predicate, Part IV of the Fourth Schedule and the MD-26 checklist set the list, including design, risk, biocompatibility, clinical or waiver data and labelling.
Q6. Does every EU-approved medical device qualify for the waiver?
No. Eligibility depends on Rule 63 and its conditions, including predicate status and two years of marketing.
