The Union government has notified the Medical Devices Rules on Tuesday as Medical Devices (Amendment) Rules, 2022. The Rules made provisions for all class A medical device manufacturers to register themselves through an identified online portal established for the purpose.
Class A medical devices are those with low-to-moderate risk to the patient or user (like surgical dressings). All class A and class B manufacturers are required to transition to the licensing regime by October 1.
Several manufacturers are awaiting audits from the government licensing authorities. Online registration with self declaration would make this transition process easier.
The manufacturer has to give an undertaking stating that the proposed device is class A medical device — non-sterile and/or non-measuring. This was a long-standing demand from the medical devices industry.
“An undertaking (is needed) from the manufacturer stating that the proposed device is class A medical device (non-sterile and/or non-measuring), according to First Schedule of the said rules,” the notification read.
The manufacturer will have to self-certify that the product is conforming to the essential principles checklist of safety and performance of such devices, the government said in the notification. It added that the manufacturer shall self-certify to comply with the standards prescribed in the Medical Devices Rules, 2017. After furnishing the information on the “Online System for Medical Devices” established for the purpose, registration number will be generated.
In case of an importer of medical devices, the importer will upload the name and address of the importer and the manufacturing site together with details of medical devices. The importer, too, will have to give an undertaking stating that the proposed device is a class A medical device, and it conforms to essential principles of safety.
In case of importers, a self-attested copy of the overseas manufacturing site or establishment or plant registration in the country of origin issued by a competent authority would be necessary.
The manufacturer or importer is required to maintain records of manufacturing, import along with sales and distribution. They would have to produce such records upon request by the licensing authorities, the notification said.
“The licensing authorities may verify the records, documents at any point of time and investigate quality or safety-related failures or complaints,” it added.
The state or central licensing authority may cancel the registration number or suspend it, if the manufacturer or importer fails to comply with these rules. Business Standard