In the world of medical device regulation, safety, quality, and performance are paramount. Over the past years, the Hospital Authority (HA) has supported the Government’s objective to safeguard public health by imposing MDACS-listing commitment requirements in tenders/quotations for certain medical devices (implantable MDs, antimicrobial dressings and guidewires). To further strengthen their procurement strategy, HA will be (i) extending the MDACS-listing commitment requirement and (ii) giving preference to MDACS-listed medical devices in the procurement of all applicable medical devices (Class II/III/IV general medical devices and Class B/C/D in-vitro diagnostic medical devices). In conjunction with this announcement, Medical Device Division (MDD) - Department of Health Hong Kong also issues a dedicated supplementary form, namely MD111 Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA) which is to be submitted together with other required documents in listing medical devices applications.

Understanding MD111

The MD111 Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA) is a supplementary form applicable to devices procured by HA within the past 12 months. Successful tenderers/bidders who have committed to submit their medical devices for listing on the MDACS should include this information sheet alongside relevant listing application forms and required documents for the regulatory authorities’ consideration.

Key Components of the MD111

The MD111 Supplementary Information Sheet covers various important aspects:

• Particulars of Local Responsible Person (LRP): Details about the LRP, including name and address, contact details, and application number of the submitted medical devices (if known)
• Device Details: Information about the medical device, including the device description, manufacturer name, and model specifications.
• Information on Medical Devices Procured by the HA: Information on the procurement by HA, including HA Tender/Quotation reference, the contract commencement date, and name of supplier within the past 12 months device was procured by HA.

By submitting the supplementary information sheet, applicants will agree to the following: (i) the information and the listing status relevant to the medical devices provided may be shared by the Government with the Hospital Authority, and (ii) the Government may, for the purpose of processing relevant MDACS listing application, request further information from the Hospital Authority.

Submission Process

The MD111 form are applicable to devices procured by HA. This form should be submitted together with other relevant applications forms and required documents as referenced in the guidance notes issued by MDD. Submitted medical device listing application under MDACS which haven’t received listing outcome are encouraged to update to their subject vetting officer by providing this supplementary information form if their medical devices have been procured by HA.

Looking Ahead

The introduction of MD111 has set a precedent for further medical device procurement strategies that support the long-term statutory regulatory framework for medical devices set by MDD. Although, still in its voluntary phase, manufacturers or distributors looking to expand their market to Hong Kong’s market should consider listing their medical devices to MDACS. Medical devices, especially those procured by HA, can provide the dedicated form which will provide supplemental information to regulatory bodies for the purpose of processing the listing application.

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References:

MDD - Application for listing of medical devices procured by the HA

(MD111) Supplementary Information Sheet

HA Announcement: Enhancement of MD Procurement Strategy