The Ministry of Health and Family Welfare vide its notification dated 10th December 2021 has notified the Medical Devices ( Draft Amendment) Rules, 2021 to further amend the Medical Devices Rules, 2017.
The Amendment is brought under rule 36 which deals with grant of import licence in which sub-rule 3 has been notified as follows:
Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, United Kingdom or United States of America, a licence shall be granted to the applicant without carrying out clinical investigation.
The Ministry has invited Objections and suggestions from the public on the above draft, which shall be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in. within a period of forty-five days.
