Science TechnologyMonday, 24 August 2026·The Hindu - National
Medical Devices Rules, 2017 amended: outsourced sterilisation licence eased, EU added for clinical waiver
The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017 to ease licensing for outsourced sterilisation and expand jurisdictions for clinical investigation waivers.
Key highlights
Direct fact
On 24 August 2026, the Union Health Ministry proposed amendments to the Medical Devices Rules, 2017, removing the need for a separate licence for outsourced sterilisation and adding the European Union to the list of stringent regulatory jurisdictions for clinical investigation waivers.
Key specifics
- Rule 44 is being amended to remove a separate loan licence for outsourced sterilisation.
- The sterilisation facility must already hold a valid licence under the Medical Devices Rules, 2017.
- Manufacturers must still print the sterilisation facility’s licence number on the medical device label.
- A 6-month transition period has been given for label and packaging changes.
- Rule 63 now includes the European Union, alongside the United States, the United Kingdom, Australia, Canada and Japan.
Exam lens
Science and technology plus regulation question, Medical Devices Rules, 2017, Rule 44, Rule 63, 6-month transition, EU inclusion — TNPSC may ask which jurisdictions are recognised for waiver of clinical investigation requirements in India.