These devices, classified as non-sterile and low-risk, include catheters, disposable perfusion sets and surgical dressings among others. The Govt said this information also has to be shared on its “Online System of Medical Devices.”
Earlier, it was not mandatory for manufacturers to share the specific details with the Govt.
In the new notification, the Centre has proposed registration of Class A category medical devices, thus making these pharma products registered through an identified online portal established for this purpose.
“The manufacturers of a medical device shall upload the information such as name & address of manufacturing site, details of medical device, generic name, brand name, model number, intended use, dimension, shelf life and material of construction. Further, the manufacturers and importer shall self-certify that the product is conforming to the essential principles‘ checklist of safety and performance of such devices and comply to the standards prescribed in the medical device rules, 2017,” said the notification.
“Besides, this manufacturer or importer has to maintain the records of manufacturing/import along with its sales or distribution and should present the records before licensing authority as and when required. The licensing authorities can verify the records and documents at any point of time and investigate quality or safety related failures or complaints,” the document stated.
In India, medical devices are classified into four categories—with class A being the low-risk medical devices, class B low-moderate risk, class C moderate-high risk and Class D high-risk.
Makers of class D equipment have to follow a stringent procedure to get licenses for manufacturing.
Queries sent to health ministry spokespeople did not elicit a response.
