14 June 2023
Author: Jenny Lin, Senior Manager, Medical Devices / IVD, Australia
The voluntary Medical Device Administrative Control System (MDACS) has been in place in Hong Kong since 2004 in preparation for future enactment into legislation. Whilst it is currently not a mandatory requirement for medical devices to be listed with the MDACS, those included under the system are more likely to be successful in the public tender process than their non-listed counterparts in the public sector. This matters because more than 70% of healthcare facilities in Hong Kong are public institutions, which are managed through the Health Authority under the Department of Health (DH).
After a successful pilot run implemented on 1 October 2022, where certain medical devices (e.g., blood glucose meters) listed under MDACS are given preference in the tender/quotation process, the DH now announced its “new strategy” to extend the preference to all medical devices listed under MDACS, starting from 21 June 2023.
This new strategy will help the DH to ensure the products procured by the public sector meet the safety, quality and performance requirements comparable to international standards.
Manufacturers are encouraged to list their devices as soon as possible if they are interested in supplying their products to DH Services.
If you have any questions or need assistance with Hong Kong registration, be sure to reach out to the PharmaLex team for a no-obligation discussion.