First proposed in 2003 and based on recommendations from the Global Harmonization Task Force, Hong Kong’s Department of Health (DOH) launched the Medical Device Administrative Control System (MDACS). MDACS, which is managed by the Medical Device Control Office (MDCO), will be launched in phases. The first phase, which began on November 26, 2004, allows medical device companies to voluntary list their Class IV (high risk) medical devices. The other key components of the MDACS scheme will follow, including: listing of Class II and Class III medical devices; establishing an Adverse Incident Reporting System; listing of manufacturers and importers; the accreditation of Conformity Assessment Bodies (CABs); launching a website for healthcare professionals, manufacturers and the public, which will list regulatory requirements and safety information of medical devices; and implementing post-market surveillance for corrective measures. MDCO hopes that the new MDACS system will help increase the public’s awareness of medical device safety and also provide valuable reference information on medical device regulatory requirements for manufacturers and importers.
Once all the phases of MDACS have been implemented, the System will be made up of two main components: the Listing System and the Adverse Incident Reporting System.
The Listing System will allow medical device manufacturers and importers to voluntarily list their devices with the DOH (except Class I devices), as long as the device has been shown to conform to the MDACS safety and efficacy standards. The listing will include the make and model of the medical device, and the name and contact information of the manufacturer. The Adverse Incident Reporting System will help the DOH monitor adverse incidents from medical devices in Hong Kong.
The MDACS will require manufacturers to have a Local Responsible Person (LRP). Each manufacturer who does not have a registered place of business in Hong Kong will have to designate a LRP in order apply for inclusion in the Listing System. An LRP must be either a legal person incorporated in Hong Kong, or a natural or legal person with a business registration in Hong Kong. However, if the manufacturer has a place of business in Hong Kong, they have the option of designating themselves as the LRP (or may still designate another party as their LRP). The LRP will serve as the contact person between the medical device manufacturer, importer, DOH and users. In addition, the LRP will be responsible for such activities as the Listing application, placing the approved device on the market in Hong Kong, investigating and reporting any adverse incidents, etc.