India Adds EU Countries to Rule 63 Clinical-Evidence Exception

India’s Ministry of Health and Family Welfare notified the Medical Devices (Third Amendment) Rules, 2026 as G.S.R. 744(E) on 14 August 2026. The Gazette of India Extraordinary published the English text on 19 August 2026 (Part II, Section 3, Sub-section (i), No. 678, CG-DL-E-21082026-275639). Rule 1(ii) says the rules come into force on the date of their final publication in the Official Gazette unless specified otherwise. That force date is 19 August 2026 (Pure Global calendar reading of the gazette date). No later transition is stated.

The notification is a final amendment of the Medical Devices Rules, 2017, made under sections 12 and 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board. The draft was G.S.R. 269(E) of 10 April 2026. The note records that MDR 2017 was last amended by G.S.R. 165(E) of 2 March 2026.

This article covers the two operational insertions: European Union countries in Rule 63, and Quality Management System words in the Class A non-sterile, non-measuring (NSNM) self-certification clauses. A same-day but separate notification, G.S.R. 743(E), amends labelling and testing fees. It is not this amendment.

What Rule 63 actually is

Rule 63 sits in Chapter VIII. It is permission to import or manufacture a medical device which does not have its predicate device. After clinical investigation under Chapter VII, the application is Form MD-26; the grant is Form MD-27. That pathway is not ordinary import licensing under Rule 34–36, and it is not a general waiver of Indian clinical investigation for every CE-marked device.

The fourth proviso in the 2017 rules already allowed the results of clinical investigation not to be submitted where the investigational device is approved by the regulatory authorities of the United Kingdom, the United States of America, Australia, Canada or Japan, and the device has been marketed for at least two years in that country, and the Central Licensing Authority is satisfied with the data of safety, performance and pharmacovigilance, and:

• (a) there is no evidence or theoretical possibility, on the basis of existing knowledge, of any difference in the behaviour and performance in the Indian population;
• (b) the applicant has given an undertaking in writing to conduct post-marketing clinical investigation for safety and performance under a protocol approved by the Central Licensing Authority.

G.S.R. 744(E) Rule 5 inserts, after “or Japan”, the words “or European Union countries”. It does not rewrite (a) or (b), the two-year marketing condition, or the CLA’s satisfaction requirement. It does not amend Rule 64 (permission for a new in vitro diagnostic medical device).

Pure Global reading (limited to that wording): the legal test is still approval by the regulatory authorities of the listed jurisdictions. The notification does not mention CE marking, Regulation (EU) 2017/745, or a notified-body certificate as the substitute for those words. Which EU act or national decision counts as “approved by the regulatory authorities of … European Union countries” is not defined here.

Rule 36(3), as originally notified in G.S.R. 78(E) and later including the United Kingdom, already listed European Union Countries among the free-sale-certificate jurisdictions for grant of an import licence without carrying out clinical investigation. That is a different rule, for a different form of licence. Investigational or new IVD devices still required prior permission in Form MD-27 or MD-29 under Rule 36(6). Do not treat G.S.R. 744(E) as if it newly invented EU reliance for every Indian import.

Class A NSNM self-certification now names QMS

Rules 19H and 19J are the Online System for Medical Devices registration route for Class A non-sterile and non-measuring devices (inserted when those devices were taken out of the ordinary licensing regime). Before this notification, Rule 19H(2)(v) and Rule 19J(2)(v) required the manufacturer or importer to self-certify compliance with “the standards specified in these rules.”

G.S.R. 744(E) Rules 2 and 3 insert, after “standards”, the words “and Quality Management System”. The self-certification now covers standards and a Quality Management System specified in these rules.

Pure Global reading: the instrument adds those words to an existing self-certification clause. It does not, in this notification, impose a manufacturing licence, a notified-body audit, or a named ISO 13485 certificate on Class A NSNM files. What evidence CDSCO will expect against the new words is not spelled out here.

Rule 4 substitutes the marginal heading of Rule 19 with “Government Medical Device Testing laboratories”. That is a heading change, not a new testing duty.

What manufacturers and importers should do now

Derived from the insertions above, not from a new inspection campaign:

1. Map no-predicate pipelines to Rule 63, not to a generic “EU waiver.” If the product needs Form MD-26, EU-country approval is now a listed jurisdiction under proviso (iv). The two-year marketing data, CLA review, population-difference analysis, and post-marketing investigation undertaking still have to be met.
2. Do not retire Indian clinical-investigation plans solely because the device is CE marked. The notification never uses that test.
3. Leave Rule 64 IVD files on their own track. This gazette does not add EU countries there.
4. Update Class A NSNM upload templates so the Rule 19H / 19J self-certification covers Quality Management System as well as standards.
5. Keep Rule 36 FSC files separate from Rule 63 investigational-device files. EU already appeared in Rule 36(3); this gazette is not that clause.

The authentic English PDF is the Gazette file linked above. CDSCO’s Gazette Notifications index is the landing page. For the broader Indian registration pathway, see Pure Global’s India market page.