Requirements (MDACS)

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 Control Office (MDCO) Department of Health to facilitate the transition to the long-term statutory control.

Reference : https://www.mdco.gov.hk/english/mdacs/mdacs.html

 

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:

  1. Ensuring the standard of medical devices imported
  2. Keeping transaction records of import/supply medical devices to permit prompt and complete withdrawal of the device(s) from the market when needed
  3. Proper handling of stock, appropriate storage, adequate incoming and outgoing inspection to ascertain the safety, performance and quality of the medical devices
  4. Managing field safety notices such as product recalls, alerts and modifications
  5. Managing reportable adverse incidents in Hong Kong
  6. Handling complaints related to any of imported medical devices
  7. Tracking of specific medical devices down to patient or user-facility level
  8. Providing preventive and corrective maintenance services to the medical devices including calibration, provision of spare parts and other maintenance services

 

Submission of documented procedures

These procedures are considered essential for the evaluation of an application.  The listed importer must establish its own procedures taking account of the workflow, operations, nature of medical devices, reporting and follow up requirements, organization structure and needs of its own organization.

 

Requirements for inspections

Allow the MDCO to perform inspections of the listed importer’s premises where business operations are carried out as well as any related storage, transaction records, documented procedures and/or transportation facilities.

 

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:

  1. The listing of an importer carries no implication that its medical devices are listed; and
  2. Clearly state whether any of the medical devices presented in the same article is listed under the MDACS.

 

Source : [GN-07] Guidance Notes for Listing of Importers of Medical Devices (Apr 2018 Edition)

 

The public can visit the MDCO 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