Under the current regulation, a Good Manufacturing Practice (GMP) certificate obtained from the Food and Drug Administration (FDA) is a voluntary requirement for local medical device manufacturers. However, manufacturers of licensed medical devices and detailed notification medical devices must provide GMP certificates from the FDA or an ISO 13485 certificate issued by one of the official Certified Bodies as part of the documents for the registration of medical devices. These certificates are not required to manufacture and notify low-risk medical devices unless they are exported and certain certificates are required by the destination countries.
It is expected that the FDA will announce the GMP regulations in 2022 or early 2023, which will require new manufacturers to obtain either GMP certificates from the FDA, ISO 13485 certificates from official Certified Bodies, or other equivalent certificates pre-approved by the FDA. Grace periods will be given to existing manufacturers, i.e., two years for licensed medical devices, three years for detailed notification medical devices, and four years for low-risk medical devices or by 2027.
The GMP regulations will not apply to local manufacturers of medical devices which already have specific quality systems such as blood bags, condoms, surgical gloves or medical devices for export only.