The Department of Health (DH) in Hong Kong has conducted the pilot run on the procurement of medical devices (MDs) earlier since October 2022. Further to that, DH will adopt a new strategy on the procurement of MDs starting from 21 June 2023. Under this strategy, DH will give preference to MDs listed under the Medical Device Administrative Control System (MDACS) in the procurement of all applicable MDs. The applicable MDs that are impacted by this procurement refer to Class II/III/IV general medical devices and Class B/C/D in-vitro diagnostic medical devices according to the classification rules of MD under MDACS.

The new strategy will help to intrinsically ensure that the MDs being purchased by DH will meet the safety, quality, and performance requirements comparable to international standard. Furthermore, the safety alert monitoring mechanism and the Medical Device Adverse Event Reporting System of Medical Device Division (MDD) also provide additional protection to the public health.

Traders who are interested in submitting bid/ quotation/ tender for the supply of MDs to DH Services are encouraged to apply their Class II/III/IV general MDs or Class B/C/D in-vitro diagnostic MDs for listing under the MDACS as soon as possible. Application form, guidance notes for listing under MDACS and individual invitation documents issued by DH for details of other procurement requirements are available on MDD website (Department of Health | Medical Device Administrative Control System (mdd.gov.hk)).

For details of the new requirement and related resources, please refer to attached document on the following link (PowerPoint 簡報 (mdd.gov.hk)).

 

 

References:

Department of Health | New strategy on procurement of medical devices (mdd.gov.hk)

Department of Health | Medical Device Listing Application (mdd.gov.hk)