The Ministry of Health and Family Welfare on 14th October 2022, has published the Medical Devices (Sixth Amendment) Rules, 2022 to further amend the Medical Devices Rules, 2017.
Through this amendment, a new chapter IIIB which deals with registration of class A (Non-sterile and Non-Measuring) medical device has been notified. This Chapter shall be applicable to all non-sterile and nonmeasuring devices classified as Class A medical devices and it shall be registered through an identified online portal established for the purpose.
The manufacturer shall upload the following in the Online System for Medical Devices, namely:―
- name and address of the manufacturing site;
- Details of Class A non-sterile and non-measuring medical devices such as brand name, model no, intended use etc.
- 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 specified in these rules; and
- An undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.
The registration number for a Class A non-sterile and non-measuring medical device shall be generated after furnishing of the information in accordance with rule 19H on the Online System for Medical Devices established for this purpose.
The manufacturer or, as the case may be, importer shall maintain the records relating to manufacturing or importing along with its sales or distribution. The Licensing Authorities may verify the records and documents at any point of time and investigate quality or safety related failures or complaints.