Currently, there is no specific legislative control over the importation and sale of medical devices in Hong Kong. To safeguard public health, Medical Device Administrative Control System (MDACS) has been set up by Medical Device Division* (MDD) Department of Health to facilitate the transition to the long-term statutory control.
Reference : https://www.mdco.gov.hk/english/mdacs/mdacs.html
*The Medical Device Control Office under the Department of Health has been renamed as the Medical Device Division with effect from 1 October 2019.
For a qualified listed importer, there are requirements for listing of importer under MDACS strictly to fulfill. The requirements are in general stated below:
Listed Importer/Local Responsible Person must have a properly manned office in Hong Kong where business operations for the import of medical device(s) are carried out. The listed importer shall document the procedures to define the controls needed for the identification, storage, security and integrity, retention time and disposition of records. Records shall be established and maintained to provide evidence of conformity to the requirements and the effective implementation of the procedures.
Establishment of documented procedures covering the following areas:
Submission of documented procedures
Requirements for inspections
Requirements in respect of advertisement, promotional material, etc.
The listed importer is in compliance with the MDACS requirements on listed importers, it shall at the same time include a statement to the effect that:
Source : [GN-07] Guidance Notes for Listing of Importers of Medical Devices (Apr 2018 Edition)
The public can visit the Medical Device Division webpage to verify the information of listed importer of medical devices.
List of Medical Device Importers : https://www.mdco.gov.hk/english/sd/sd_li/sd_li.php
List of Local Responsible Persons : https://www.mdco.gov.hk/english/sd/sd_lrp/sd_lrp.php