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The pilot of new requirement on the procurement of Medical Devices (MD) by the Department of Health

2022-09-02

As you might be aware, MDD has been implementing the voluntary Medical Device Administrative Control System (MDACS) since 2004 to raise public awareness of the importance of medical devices (MDs) safety and pave way for the introduction of long-term statutory control. The MDACS provides a two-pronged protection to users of MDs, including the pre-market control and post-market control.

In order to enhance the customer protection for DH as a buyer of MDs, to ensure the safety, quality and performance of the medical devices procured and the availability of after-sale (post-market) support from suppliers, DH will introduce a pilot on procurement of MDs with effect from 1st October 2022. Under the pilot, certain MDs (including condoms, lubricants of Class II or above, blood glucose meter and blood glucose strip) being purchased by DH should preferably be listed under the MDACS. Subject to the experience gained from the pilot, DH will include more MDs into the scheme, with an aim to cover all MDs being procured by the DH. For details, please refer to MDD website (http://www.mdd.gov.hk/en/whats-new/mdacs-activities/index-id-2307.html).

Traders who are interested to submit quotation/tender for the supply of MDs for services of DH are encouraged to apply for listing of their MDs under the MDACS as soon as possible. Please refer to the website (http://www.mdd.gov.hk/en/mdacs/listing-application/medical-device/index.html) for application details.

Should they have any enquires regarding the new procurement requirement and listing applications, please feel free to approach MDD enquiry channels (Tel: 3107-8484, e-mail: mdd@dh.gov.hk). For details of the procurement quotation/tender requirements for a particular MD, please refer to the invitation document issued by the respective procuring service of DH.

 

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