Hong Kong: Additional Requirement for Procurement of Medical Devices

ARQon
Jun 23, 2023
1 min read

The Department of Health (DH) announced the implementation of a new requirement for medical devices procurement will be effective from 21 June 2023.

Priority will be concerned with the medical devices grouped under the Medical Device Administrative Control System (MDACS) to procure medical devices. The same priority will be given in terms of quotation and tender. Priority will be given to the medical devices under MDACS for any similarly offered quotation prices and extra marks will be awarded for MDACS-listed medical devices offered, which are Class II, III, and IV general medical devices and Class B, C, and D for in-vitro diagnostic medical devices.

It is also required that the submission is submitted by the supplier as compliance evidence the medical devices offered are listed in the MDACS. Besides, suppliers have to come up with Hong Kong Medical Device listing number and a valid copy of Certificate of Listing under MDACS.

This requirement aims to enhance the safety, quality, and performance of the medical devices and secure the supplier's after-sale service availability. It also helps to raise public awareness on the importance of listing medical devices under MDACS as that will guarantee the safety of the medical devices.

Source: Medical Device Division