Draft Medical Devices (Third Amendment) Rules, 2019

Apr 24, 2019 | by Avantis RegTech Legal Research Team


The Ministry of Health and Family Welfare (MoHFW) on April 18, 2019, after consultation with the Drugs Technical Advisory Board, has published a draft Medical Devices (Third Amendment) Rules, 2019, to further amend the Medical Device Rules, 2017. It will come into force on the date of their publication in the Official Gazette. 

In Rule 91 of Medical Devices Rules, 2017 which specifies ‘Export of medical devices’, amendments have been made, namely:

“Where a person intends to export any medical device, manufactured in India, and for that purpose, requests a certificate in the nature of free sale certificate or a certificate about quality, safety and performance in relation to that medical device as required by the authority concerned of the importing country, such person, may apply to the Central Licensing Authority for Class C and Class D medical devices and State Licensing Authority for Class A and Class B medical devices for the purpose along with a fee as specified in the Second Schedule and the said authority shall, if the requirements are fulfilled, issue a certificate to the applicant.”

Also, the amendments have been made in the Second Schedule, in the Table relating to fee payable for licence, permission and registration certificate.

The objections and suggestions are invited from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said Notification were made available to the public. 

[Notification No. G.S.R. 318(E)]

Click here to download the Notification.


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