The Medical Device Control Office of Hong Kong (MDCO) has proposed listing local manufacturers of medical devices under the Medical Device Administrative Control System (MDACS). The main requirement to be listed will be for manufacturers to implement and maintain a quality management system. A manufacturer is eligible to apply if they have a business registration in Hong Kong.
The quality management system must comply with ISO 13485 or the equivalent and MDACS requirements pertinent to the medical devices they produce. Local manufacturers can demonstrate this compliance through certification by a recognized conformity assessment body. Certification must cover all medical devices made by the manufacturer, including those that are for export only.
For manufacturers of Class III and IV devices, this quality management system must also include design and development specifications. Class I and II medical device manufacturers do not need to include design and development in their quality management system.
Any major changes made to the quality management system after certification must be reported to the MDCO. Manufacturers must also be prepared to provide any records or documents related to the quality management system or their products. The MDCO may perform audits on the manufacturers and any of their major contract manufacturers or sterilizers if necessary.
A listed manufacturer may be permanently or temporarily removed for various reasons, such as not complying with MDACS requirements or failing to address any adverse events. Manufacturers can appeal a removal within four weeks of being notified of the decision.
Listing of a local manufacturer does not indicate any official approval of the manufacturers’ products. In fact, any public documents or advertisements stating that a local manufacturer has been listed must also clearly state that the listing is not the same as the listing of approved medical devices.