Medical Devices Rules, 2017: no separate loan licence for outsourced sterilisation; EU added for clinical-investigation waiver, says Health Ministry
The Health Ministry says the Medical Devices Rules, 2017 have been amended. Under amended rule 44, a manufacturer that outsources sterilisation to a facility holding a valid licence under the Rules no longer needs a separate loan licence for that activity. Rule 63 now includes the European Union among the jurisdictions recognised for waiver of clinical investigation.
Key facts
- In force
- Not stated in the release; six-month transition period for the new labelling requirement
- Who it affects
- Medical device manufacturers that outsource sterilisation, sterilisation facilities licensed under the Medical Devices Rules, 2017, importers of medical devices approved in the European Union
- What it is
- Rule change
- Section
- Licences
- Published
- 24 August 2026
In 30 seconds
- Rule 44: manufacturers outsourcing product sterilisation to another facility holding a valid licence under the Medical Devices Rules, 2017 will no longer need a separate loan licence for the outsourced sterilisation.
- The amended provision gives a six-month transition period for implementation of the new labelling requirement.
- The release says an essential traceability mechanism for outsourced sterilisation is retained.
- Rule 63: the European Union is added to the recognised stringent regulatory jurisdictions for waiver of clinical investigation for medical devices without predicate devices.
- The jurisdictions recognised so far are the United States of America, United Kingdom, Australia, Canada and Japan.
- The headline of the release speaks of “proposed” amendments on testing fees and faster market access; the text of the release gives no details of these.
हिंदी में सार
स्वास्थ्य मंत्रालय के अनुसार Medical Devices Rules, 2017 में संशोधन किया गया है। नियम 44 के तहत, जो निर्माता sterilisation का काम इन्हीं नियमों के तहत वैध लाइसेंस वाली दूसरी यूनिट से कराते हैं, उन्हें अब इसके लिए अलग loan licence नहीं लेना होगा; नई लेबलिंग शर्त के लिए छह महीने का समय दिया गया है। नियम 63 में clinical investigation की छूट के लिए मान्य देशों की सूची में यूरोपीय संघ (EU) जोड़ा गया है। लागू होने की तारीख़ रिलीज़ में नहीं दी गई है।
Before and now
United States of America, United Kingdom, Australia, Canada and Japan.
The same five, plus the European Union.
What the Ministry has announced
In a release dated 24 August 2026, the Union Ministry of Health and Family Welfare says the Medical Devices Rules, 2017 “have recently been amended” on two points: outsourced sterilisation of medical devices (rule 44) and the list of recognised stringent regulatory jurisdictions for waiver of clinical investigation (rule 63). The release links the Official Gazette notification.
Rule 44 — outsourced sterilisation
According to the release, the amendment to rule 44 was finalised after stakeholder consultations. Under the amended provisions:
- a manufacturer that outsources product sterilisation to another facility holding a valid licence under the Medical Devices Rules, 2017 will no longer be required to obtain a separate loan licence for the outsourced sterilisation activity;
- a six-month transition period is provided for implementation of the new labelling requirement, so that manufacturers can change their labelling, packaging and related processes before the provision comes into effect;
- an essential traceability mechanism for outsourced sterilisation is retained.
The Ministry says this removes duplication and reduces administrative burden, compliance costs and timelines, particularly for manufacturers that do not have in-house sterilisation facilities.
Rule 63 — European Union added
| Point | What the release says |
|---|---|
| What rule 63 deals with | Waiver of clinical investigation requirements for medical devices without predicate devices |
| Jurisdictions currently recognised | United States of America, United Kingdom, Australia, Canada and Japan |
| Added now | European Union (EU) |
| Effect, as stated | Eligible medical devices already approved in the EU will be able to benefit from the waiver provisions |
The Ministry expects this to reduce the regulatory burden and timelines for importers and manufacturers.
What the release does not spell out
The headline and sub-heading of the release describe the amendments as “proposed” and mention standardising testing fees and faster market access for eligible devices. The text, however, describes only the rule 44 and rule 63 changes, and describes them as already made. It does not give the notification number, the date of the amendment, the date it takes effect, or what the new labelling requirement is.
What manufacturers and importers should do
Read the Gazette notification linked in the release before acting on it. Manufacturers that send devices out for sterilisation should check that the facility holds a valid licence under the Medical Devices Rules, 2017, and use the six-month transition to make the labelling and packaging changes. Importers and manufacturers of devices without a predicate that are already approved in the EU should check whether the waiver provisions now apply to them.
Questions and answers
Is a separate loan licence still needed for outsourced sterilisation of medical devices?
According to the Health Ministry’s release, no — where the manufacturer outsources product sterilisation to another facility holding a valid licence under the Medical Devices Rules, 2017, a separate loan licence for that outsourced activity is no longer required under amended rule 44.
Is there a transition period?
The release says the amended provision gives a six-month transition period for implementation of the new labelling requirement. It does not describe the labelling requirement itself.
Which jurisdictions are recognised for waiver of clinical investigation?
Rule 63 recognised the United States of America, United Kingdom, Australia, Canada and Japan. The release says the European Union has now been included, for medical devices without predicate devices.
From what date do the changes apply?
The release does not state the date of the notification or the date of effect. It links the Official Gazette notification, which should be read for these.
Published 24 August 2026. Updated 7 October 2026. This report is for general information and is not professional advice. Read the source document before acting on it.