Hong Kong has clarified the roles for local manufacturers and listed importers and suppliers of medical devices. Hong Kong’s Medical Device Control Office maintains a list of importers under the Medical Device Administrative Control System (MDACS) and devicemakers wanting to import and supply medical devices are encouraged to apply for listing as importers under the MDACS system.
The listed importer must have a “manned office” in Hong Kong where import operations are carried out. The listed importer should document procedures to define controls needed to identify, store, secure and retain records documenting disposition of products. The importer should retain these records for at least seven years after the projected service life of the medical device.
The listed importer is responsible for ensuring the device manufacturer maintains a quality management system that includes handling adverse events. The listed importer must also maintain records so devices can be traced and promptly withdraw from the market if necessary.