The Ministry of Health and Family Welfare on Tuesday notified draft amendment rules for the registration of Class A medical devices through an identified online portal established for the purpose.
All the A and B-class manufacturers are required to transition to the licensing regime by 1st October. This notification came as a big relief to the manufacturers who are still awaiting audits from the government licensing authorities.
The Key highlights of the draft amendment rules for Manufacturer
- The manufacturer has to only submit an undertaking stating that the proposed device is Class A Medical Device (non-sterile and/or non-measuring)
- The manufacturer shall self-certify that the product is conforming to the essential principles’ checklist of safety and performance of such devices.
- The manufacturer shall self-certify to comply with the standards prescribed in the Medical Devices Rules, 2017.