On the 4th of July 2024, the Department of Health (DH) announced its movement towards the second phase in enhancing the measures of medical device procurement. The first phase has been adopted since 21 June 2023 which preferably requires applicable medical devices to be listed under the Medical Device Administrative Control System (MDACS).
The push to be listed under MDACS aims to raise public awareness of the Department of Health’s commitment to prioritizing the safety, quality, and performance of medical devices available in Hong Kong.
There will be 2 stages under the second phase of enhanced measures of the new strategy:
Stage 1 (effective from 1 November 2024)
Requirement for procurement under quotation procedures (including minor purchases)
The applicable medical devices (AMD)* shall be listed MDs, or,
Having an application submitted for listing under MDACS with an Application Number issued by MDD before the quotation closing time
Requirement for procurement under tender procedures with/without marking scheme
Desirable requirement that the AMD offered should be a Listed MD
Stage 2 (expected implementation in 2025, following a review of Stage 1)
Requirement for procurement under quotation or tender procedures, all AMDs shall be Listed MDs
Supporting documents for the Supplier to demonstrate compliance with the requirements as follows:
For MDs listed under MDACS:
HKMD listing number
A copy of a valid certificate of Listing under MDA
Expiry date of the certificate of listing shall be after tender/quotation closing date
For applications for listing of MDs under MDACS already submitted to MDD:
A copy of acknowledgment email from MDD with the application number(s) indicated relevant to the offered item(s)
The time of the acknowledgment email shall be before the tender/quotation closing time
Traders are encouraged to apply for the listing of their AMDs under MDACS as soon as possible to be eligible to supply MDs to DH services.
Source: Medical Device Division (MDD)
Contact us at info@arqon.com for more information.
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