Health Ministry proposes to simplify registration procedure for Class A (Non-Sterile and/or non-measuring) Medical Devices under Medical Device Rules, 2017; invites comments / suggestions by 27th September, 2022
The Ministry of Health and Family Welfare (“Ministry”) has published draft amendments to propose further changes to the Medical Device Rules, 2017 (“Rules”). Provisions have been proposed to exempt non-sterile, non-measuring Class A medical devices from the existing licensing regime.
The Ministry has invited comments / suggestions from the public and such comments / suggestions, if any, must be addressed to -Under Secretary (Drugs), Ministry, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 in writing or through e-mail at drugsdiv-mohfw@gov.in by 27th September, 2022.
Key Highlights:
• The Ministry has proposed to introduce a new Chapter III B which pertains to Registration of Class A (Non-sterile and / Or Non-Measuring) Medical Devices. Further, amendments have been proposed to the eight schedule to exempt the manufacture and import of such devices from all provisions of Chapter IV and Chapter V of the Rules respectively subject to the manufacturer or importer obtaining registration under the new Chapter III B;
• Chapter III B of the Rules apply to all non-sterile and / or non-measuring devices classified as Class A medical devices which shall be required to be registered through an identified online portal;
• The manufacturer of the medical devices is required to upload information relating to such medical devices for registration to the “Online System for Medical Devices”;
• To import any medical devices, the importer shall upload details relating to such medical devices for registration to the “Online System for Medical Devices”.
After furnishing the required information on the “Online System for Medical Devices” a registration number shall be generated.
• The manufacturer / importer shall maintain the records of manufacturing / import along with its sales or distribution.
A copy of the Notification is attached herewith for ease of reference.
Source: Ministry of Health and Family Welfare
