Hong Kong listing of medical device under the voluntary Medical Device Administrative Control System (MDACS) was launched since November 2004, and was implemented by the Hong Kong Medical Device Division (MDD) to raise awareness for public safety and prepare for future mandatory requirements.
The MDD announced new procurement requirements (pilot run) for the supply of certain medical devices to the Department of Health (DH), including Hong Kong public hospitals, with effect from October 1, 2022, onwards.
Scope
Under the pilot run, the following medical devices shall preferably be listed under the MDACS for procurement by the DH:
- condoms of class II or above
- lubricants of class II or above
- blood glucose meter
- blood glucose strip
In general, 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 Hong Kong listing.
Purpose
- To enhance the customer protection for Department of Health (DH) as a buyer of medical devices
- To ensure the safety, quality and performance of the medical devices procured and to ensure the availability of after-sale (post-market) support from suppliers
- To strike a balance between value for money purchase while enhancing public safety
- To raise public awareness of the importance of MD safety and pave way for the introduction of long-term statutory control
Procurement Requirements
- Medical device being procured by the DH is preferably listed under the MDACS
- Quotation: A preference will be given in the quotation for listed medical devices under the MDACS
- If there are more the one lowest conforming offers offering the same price, preference will be given to the medical device offered which are listed under the MDACS.
- Tender: A technical score will be given in the marking scheme for listed medical devices under the MDACS
- In assessment criterion under the tender evaluation, marks will be given for medical devices offered which are preferably listed under the MDACS
- If the proposed medical device is accepted by the Government, the Tenderer shall be bounded by such offer and shall be deemed to form part of the Contract.
- Each particular medical device procurement may have different requirements hence tenderers shall refer to the tender documents for specific details.
Submissions to be provided by supplier for indicating the compliance of the desirable requirements
- To indicate in the schedule of tender / quotation whether the Item(s) offered is listed under the MDACS
- To provide the listing number and a valid copy of the certificate of listing under the MDACS.
- The vetting and approval of an application for listing a device should normally be completed within 12 weeks following the submission of the application and all the required support information, including labelling samples.
China Greater Bay Area Pathway
According to the specific prerequisites of importing Hong Kong medical devices to the Greater Bay Area (GBA) via the expedited pathway, the product must be procured and already operating in the public hospitals in Hong Kong.
The introduction of the new procurement requirements in Hong Kong becomes increasingly important to manufacturers interested in the GBA pathway, and are encouraged to apply for Hong Kong listing as early as possible whilst the Hong Kong DH plans to extend its scope to cover more medical devices.
Further information
Read the announcement of the new procurement requirements here.
Cisema can support manufacturers as their local responsible person (LRP) with Hong Kong listing of medical device. If you would like to know more about Hong Kong listing or the GBA pathway, please contact us.
