The Ministry of Health and Family Welfare (“Ministry”) through a Notification No. G.S.R. 652(E), dated 13th September 2019 has amended the Medical Devices Rules, 2017 (“Parent Rules”) by bringing out the Medical Devices (Fourth Amendment) Rules, 2019.
In the Parent Rules, the signing authority for the Form MD-10 which is for Loan License to Manufacture for Sale or for Distribution of Class C (Moderate High Risk Devices) or Class D (High Risk Devices) medical device was stated to be as the State Licensing Authority, whereas it has been mentioned in Sub-Rule 1 of Rule 25 of the Parent Rules that the signing authority for Form MD-10 will be the Central Licensing Authority.
Going forward, the Ministry through the amendment has fixed the Central Licensing Authority to be the signatory for Form MD-10.