Subordinated to the Department of Health, the Medical Device Control Office or MDCO is the department in charge of regulating medical devices in Hong Kong. It was established in July 2004 with the task to create a cost-effective regulation on the supply and use of medical devices that respects the standards recommended by the International Medical Device Regulators Forum (IMDRF). The MDCO’s mission is to ensure the people of Hong Kong have access to safe, efficient medical devices.
To ease transition to a long-term statutory control, the Medical Device Control Office setup the Medical Device Administrative Control System. This is a system where manufacturers and importers can list their medical devices with the Department of Health and also functions as a system for reporting adverse incidents. While the listing of medical devices in the system is voluntary, the Hong Kong government has plans to make the Medical Device Administrative Control System mandatory in the future.
Some of the most important regulations for medical devices in Hong Kong are:
- [GN-01] Overview of the Hong Kong Medical Device Administrative Control System
- [TR-002] Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
- [GN-00] Guidance Notes for Definitions and Abbreviations for Medical Device Administrative System.
- [GN-02] Guidance Notes for Listing Class II, III & IV Medical Devices (Jul 2011 Edition)
A full list of MDCO regulations can be found here.
- Website: http://www.mdco.gov.hk/eindex.html