The medical device industry contributes significantly to a patient’s care. To ensure the safety, efficacy, and quality of procured medical devices (MDs) in Hong Kong, the Department of Health (DH) will be implementing a second phase for the new medical device procurement strategy, building on the first phase adopted by the Department of Health (DH) since 21^st June 2023. This article provides an overview of these new measures, their impact on medical device manufacturers, and how Qualtech Consulting Corporation can assist in navigating this evolving regulatory landscape.

(More information on the first phase procurement strategy is available in our previously published article here.)

Enhanced Strategy on Medical Device Procurement: A Phased Approach

The second phase for the new medical device procurement strategy will be implemented in two stages. Applicable Medical Devices (AMD) for this procurement strategy are MDs classified within Class II/III/IV General MDs or Class B/C/D In-vitro Diagnostic MDs according to the Classification Rules of medical devices under MDACS.

Stage 1: Effective November 1, 2024

The initial stage, effective from 1^st November 2024, details the requirements and preferences for tenders and quotation held by DH. The following table provide a comparison between the first and second phase (stage 1): 

Procurement Type	First Phase (effective 21st June 2023)	Second Phase (Stage 1) (effective 1st November 2024)
Quotation	A preference will be given in the quotation for listed MDs under MDACS	An AMD offered shall be – either (a) Listed MDs; or (b) having an application submitted for listing under MDACS with an Application Number issued by MDD of DH before the quotation closing time.
	If there are more than one lowest conforming offers offering the same price, preference will be given to the MDs offered which are listed under MDACS.	If there are more than one lowest conforming offers offering the same price, preference will be given to the one with Listed MDs offered.
Tender	In assessment criterion under the tender evaluation, marks will be given for MDs offered which are preferably be listed under the MDACS.	It is a desirable requirement that an AMD offered should be a Listed MD. Procedures without marking scheme If there is more than one lowest conforming offers offering the same price, preference will be given to the one with Listed MDs offered. Procedures with marking scheme A technical score will be given in the technical assessment of the marking scheme for listed MDs

Stage 2: Expected Implementation in 2025, following a review of Stage 1

The DH anticipates implementing stricter regulations in 2025, requiring all procured medical devices to be listed on MDACS. Manufacturers are advised to closely monitor updates and revisions to the Medical Device Procurement Strategy from the DH.

Impact on Medical Device Manufacturers

The new procurement strategy encourages medical device manufacturers seeking to supply public healthcare facilities in Hong Kong to comply with MDACS. Here’s how manufacturers can adapt:

• Product Review: Manufacturers should carefully review their product portfolios to identify all applicable Medical Devices that fall under the new regulations and assess their MDACS listing status.
• Early MDACS Registration: As the implementation of these enhanced measures may lead to a surge in listing applications to DH, early registration is beneficial in order to have your devices listed on MDACS or have a pending application as soon as possible.
• Supporting Documents to Submit: To demonstrate compliance of the requirements for this new strategy, the following documents are to be submitted by the Supplier:

MDs already listed under MDACS:	MDs already submitted application for MDACS listing
HKMD listing number and copy of a valid Certificate of Listing under MDACS The expiry date of the certificate of listing shall be after the tender/quotation closing date	A copy of acknowledgement e-mail from MDD with the application number(s) indicated relevant to the offered Item(s) The time of the acknowledgement e-mail shall be before the tender/quotation closing time

Details on application for inclusion in the supplier lists of the Government can be referred to the following links:

• Application for Inclusion in the DH Supplier Lists
• Application for Inclusion in the GLD Supplier Lists

How We Can Help

The new medical device procurement strategy in Hong Kong presents both challenges and opportunities for medical device manufacturers. By proactively registering their devices on MDACS and working with experienced regulatory consultants like Qualtech Consulting Corporation, manufacturers can ensure their continued success in the Hong Kong market and continue delivering high-quality medical care to patients.

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.

Connect with us today here to unlock your medical device potential.

 

 

References:

MDD Announcement: Implementing enhanced measures for the new strategy on MD procurement

MDD Materials: The Enhanced Measures on MD Procurement