The Ministry of Health and Family Welfare (“Ministry”) has after consultation with the Drugs Technical Advisory Board, in a Notification dated 7th December, 2018, issued the draft Medical Devices (…Amendment) Rules, 2018 (“Draft Amendment Rules”) proposing to amend the Medical Devices Rules, 2017 (“Principal Rules”).
The Ministry has invited objections and suggestions from the stakeholders by 7th January, 2019, to be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.
The Draft Amendment Rules have proposed separate authorities for applying for a certificate in the nature of free sale certificate or a certificate about quality, safety and performance of medical devices in relation to export of such medical devices.
Presently, applications for such certificates, relating to export of all types of medical devices, have to be made to the Central Licensing Authority. The Draft Amendment Rules propose that such applications have to be made to
- the Central Licensing Authority for medical devices of Class C and Class D; and
- the State Licensing Authority for medical devices of Class A and Class B
Source: Ministry of Health and Family Welfare
