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Hong Kong: The pilot run of new procurement requirement will be effective on 1st Oct 2022
- ARQon
- Sep 30, 2022
- 3 min read
LISTED DEVICES TO BE GIVEN TENDER PREFERENCE BY DEPARTMENT OF HEALTH
The Hong Kong Department of Health (DH) announced the launch of a pilot program on August 29, 2022, in an email to stakeholders, giving precedence to medical devices listed in the Medical Device Administrative Control System (MDACS). The pilot program is applicable to open competitions where the Department of Health (DH) is buying medical equipment.
As per the updated advice: “If there are more than one lowest conforming offers offering the same price, preference will be given to the MD offered which are listed under the MDACS.”
The MDD intends to begin with a specific list of medical equipment, including condoms, lubricants of Class II or above, blood glucose meters, and blood glucose strips, as further described on their website. On October 1, 2022, the pilot program will start, and based on the results, it may be expanded to include more product categories.
REQUIREMENTS FOR PROCUREMENT
The Department of Health advises manufacturers and regional vendors to submit applications as soon as possible in order to maintain tender competitiveness since it will only give preference to products on the list at this time. If other goods that are not on MDACS are being considered during the tender process, the listed medical devices will be granted an additional score that could win the tender.
Participants in the tender must provide the HKMD listing number and a valid copy of the Certificate of Listing under MDACS as verification of their MDACS listing.
FREQUENTLY ASKED QUESTIONS
Q: Do I need to register my medical device in Hong Kong?
A: No. Medical device registration is currently voluntary. However, the vast majority of public hospitals and providers will require evidence of the product’s listing on MDACS.
Q: Should I register my medical device in Hong Kong?
A: Manufacturers who want to supply public hospitals should register with MDACS and apply for listing. Manufacturers can avoid possibly lengthy review processes when adopted by registering now since it is anticipated that registration would someday become required.
Q: How long does it take to register a medical device in Hong Kong?
A: Officially, it should require about 12 weeks for the MDD to review an application. However, with high demand and the effects of COVID, review times have increased to a year or more.
Q: Is my product considered a medical device?
A: The MDD has created a tool to help manufacturers determine if their product meets the definition of a Medical Device.
Options for expedited approval
The Expedited Approval Scheme is intended to assist in enhancing the review procedure in Hong Kong as review times have gotten longer in recent years. A speedier review is available for Class II, III, and IV products that have been approved by any two of the following markets:
United States (U.S. Food and Drug Administration)
Canada (Health Canada)
Europe (Member countries of the European Union that have implemented the European Council Directives or Regulations on medical devices)
Japan (Ministry of Health, Labour and Welfare)
Australia (The Therapeutic Goods Administration) – Cannot have been approved through the EU Mutual Recognition route.
China (National Medical Products Administration)
With regard to adverse event requirements, the product must not have:
-any reported deaths or serious injuries associated with the device (locally and worldwide)
-any active recalls, field safety corrective actions or adverse events (locally and worldwide)
Source:
Contact us at info@arqon.com for more information.
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