Union Health Ministry’s new rules for medical devices

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New rules for medical devices have been introduced by the Union Health Ministry, in order to remove regulatory hold-ups and improve on the medical devices availability for patients.

The new rules does not require manufactures to renew their licenses periodically. Also to make the process digital, the application submission and licenses allowance will be done online.

Key Facts:

1. The Union Health Ministry has framed new rules in conformity with the Global Harmonisation Task Force (GHTF) framework. The rules also adapt to best international practices.

2. Under the new rules, the classification of medical devices are according to the GHTF practice, into low risk Class A, low-moderate risk Class B, moderate high risk Class C and high risk Class D.

3. The new rules aims to eliminate regulatory blockages to improve ease of doing business, to promote make in India, and to ensure medical devices availability for care and safety of patients.

4. The new rules also seeks to promote a self-compliance culture among the manufacturers of medical devices.

5. Under the new rules, the manufacturing licences for low risk Class A medical devices will be approved without any prior audit of manufacturing site.

6. Under it, periodic renewal of licences is not required and the manufacturing and import medical device licences will stay valid till they are cancelled, suspended or are surrendered.

7. The complete process of application submission and grant of licence will be done online.

8. Under the new rules, the medical device manufacturers are not required to meet risk proportionate regulatory necessities.

9. The ‘Third Party Conformity Assessment and Certification’ system through Notified Bodies is expected to bring in the utmost professionalism in medical device regulation.

10. The notified bodies will undertake the process of verification and valuation of the Class A and B Medical Device Manufacturers’ Quality Management System and also for the Class C and D category manufacturers.

New rules for medical devices have been introduced by the Union Health Ministry, in order to remove regulatory hold-ups and improve on the medical devices availability for patients.

The new rules does not require manufactures to renew their licenses periodically. Also to make the process digital, the application submission and licenses allowance will be done online.

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