Draft Amendment to Medical Device Rules, 2017 relating to Export of Medical Devices

Dec 10, 2018 | by Avantis RegTech Legal Research Team

The Central Government, on December 07, 2018, has proposed to make amendments to the Medical Device Rules, 2017 after consultation with the Drugs Technical Advisory Board. The proposed amendment is published for information of all persons likely to be affected thereby and to invite objections and suggestions. The given that the said draft rules shall be taken into consideration or after the expiry of a period of 30 days from the date on which the copies of the Gazette of India these draft rules are made available to public.

The following amendments are proposed in the Medical Devices Rules, 2017:

·         In Rule 91 giving provisions for export of medical devices after the words “may apply to the Central Licensing Authority” the words “for Class C and Class D and State Licensing Authority for Class A and Class B” is proposed to be inserted.

·         In Second Schedule which gives fee payable for licence, permission and registration certificate, at serial number 51, in column 3 for the word “distinct”, the words “category of” shall be substituted.

Objections and suggestions, if any, may 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 [email protected].

[G.S.R. 1187(E)]

URL: http://www.egazette.nic.in/WriteReadData/2018/193637.pdf


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