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.
Background:
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.
Source: Ministry of Health and Family Welfare
