Hong Kong medical device listing now attains full prominence in public tenders with new measures announced by the Department of Health (DH) in effect from June 21, 2023, onwards.
Following the pilot run of procurement requirements that took place in October 2022 (read our separate blog post here), the new DH procurement measures now expanded the scope and set a higher priority for all medical devices that are listed within the Medical Device Administrative Control System (MDACS) during the procurement process for public hospitals and clinics.
Medical devices are separately grouped into four classes (class I to IV for general medical devices and class A to D for in vitro diagnostic medical devices) in Hong Kong with class D and class IV being the class with the highest risk, and class A and class I being the lowest. However, only class II to IV general medical devices and class B to D in vitro diagnostic medical devices can apply for listing under the Hong Kong MDACS.
The DH strongly encourages suppliers of class II, III, or IV general medical devices, and class B, C, or D in-vitro diagnostic medical devices to apply for listing under the MDACS in order to enhance the probability of securing a successful bid submission to the DH.
Hong Kong MDACS listing
Established in July 2004, the Medical Device Division (MDD), formerly recognized as the Medical Device Control Office (MDCO), holds the responsibility of instituting the Medical Device Administrative Control System (MDACS) and crafting an enduring statutory regulatory framework for medical devices.
The application process for inclusion in the MDACS is outlined in very simple steps as below:
- Appointment of Local Responsible Person (LRP)
- Submit MDACS application
- MDACS preliminary check
- Confirmation of completeness and correctness of dossier submission
- Phase of application review and supplementary notice(s)
- Board meeting for listing approval
Medical device commonly marketed in Hong Kong will take a minimum of application processing time of 22 weeks. The listing certificate will be valid for 5 years.
Local Responsible Person for Hong Kong listing
The role of the LRP must be designated to a legal entity in Hong Kong for submitting MDACS listing applications, performing certain obligations required by the DH and as the hub of communication between users, manufacturers, importers, distributors, and the Government. Manufacturers may decide to take up the roles of LRPs through their local offices in Hong Kong, or instead appoint a regulatory consultant like Cisema to provide the required services. Contact us if you would like to learn more.
China Greater Bay Area
With Hong Kong listing, foreign manufacturers will also have an advantage in selling medical devices to designated Greater Bay Area (GBA) medical institutions in China. The expedited GBA pathway for Hong Kong medical device was introduced in 2019 by both China and Hong Kong governments, and implemented officially after the completion of pilon plan in July 2021. As of February 2023, a total of 13 medical devices has been approved via the GBA pathway.
Read the original announcement about the Department of Health to implement a new strategy on procurement of medical devices and slide deck.
For enquiries on the definition and classification of medical devices, the Hong Kong Medical Device Division can be reached at (852) 3107 8484 or email@example.com.
If you would like to know more about Hong Kong listing or the GBA pathway, please get in touch with our specialists.