Hong Kong (HK) is part of China however they have a different regulatory system and import the majority of its medical products. They import approximately $800 million in medical equipment and the US has an estimated 26% of this market.
The Department of Health in Hong Kong has set up a Medical Devices Administrative Control System (MDACS) that is based on the Global Harmonization Task Force (GHTF) principles and is run by the Medical Device Control Office (MDCO). The purpose of the MDACS is to raise public awareness of the safe use of medical devices and to enable manufacturers and other interested parties to familiarize themselves with future mandatory requirements through use of this voluntary control system.
Implementation of the MDACS
MDACS is being implemented in several phases:
- Phase I: Voluntary listing of Class IV (High Risk) Medical Devices on 26 Nov 04
- Phase II: Voluntary listing of Class II & Class III (Medium Risk) Medical Devices on 14 Nov 2005
- Phase III: Recognition of designated Conformity Assessment Bodies (CAB) on 13 Oct 06 in which BSI was the first designated HK CAB
- Phase IV: Mandatory listing of local (Hong Kong) manufacturers on 23 March 2007
- Phase: V: Mandatory listing of importers of medical devices (except Class I) on 17 July 2007
Classification and registration requirement
HK Classification is risk-based and follows GHTF (i.e. 4 classes). A summary of registration requirements of medical device in HK
|
Class I |
Class II |
Class III |
Class IV |
| Product registration |
Not required |
Required |
Required |
Required |
| Registration of local manufacturers |
Required |
Required |
Required |
Required |
| Registration of overseas manufacturer or its local representative |
Not required |
Required |
Required |
Required |
| Registration of importer |
Required |
Required |
Required |
Required |
| Registration of retailer |
Not required |
Not required |
Not required |
Not required |
View the Hong Kong Regulatory Forum and Newsletter
