Bryan Gilburg - China

“By prioritizing products listed on MDACS, the Hong Kong Department of Health is creating a powerful incentive for manufacturers to voluntarily register their medical devices.

Albert Pranoto

Director of Business Development, Asia Actual Singapore

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Hong Kong Officially Prioritizes Registered Medical Device Procurement

Published on: June 14th, 2023

On June 5, 2023, the Hong Kong Department of Health (DH) formally published a new policy for the procurement of medical devices. Effective from June 21, 2023, the DH will prioritize the procurement of medical devices that are registered and listed under the Medical Device Administrative Control System (MDACS). This strategy aims to enhance the safety and quality of medical devices used in healthcare services provided by the DH by showing preference for medical devices listed in the MDACS.

Medical device manufacturers that wish to sell products to public hospitals and institutions should register them in MDACS.  More information on the medical device registration process can be found here on our website.

NEW PROCUREMENT PREFERENCE SYSTEM FOR MEDICAL DEVICES

Under the new strategy, the DH will prioritize medical devices listed under MDACS for the procurement of all applicable medical devices. This includes Class II/III/IV general medical devices and Class B/C/D in vitro diagnostic medical devices, as per the classification rules of MDACS. By giving preference to medical devices listed under MDACS, the DH aims to not only ensure that the procured devices meet safety, quality, and performance requirements, but to also encourage registration in a market where listings are still voluntary.

MULTIPLE BENEFITS OF MDACS LISTING

  1. Increased sales to public hospitals/clinics: As per the new policy announcement, MDACS listing will enhance your chances of securing procurement opportunities with the Department of Health, which represents over 50% of health care in Hong Kong.
  2. Increased sales to private hospitals/clinics: By demonstrating compliance with the essential principles of safety and performance, MDACS listing boosts your credibility as a trusted supplier in the private health sector.
  3. Expedited access to hospitals in Southern China: The China NMPA is allowing certain products that are registered in Hong Kong to be sold to qualified hospitals without an NMPA issued Medical Device Registration Certificate. More information on the Work Plan for Supervision, Innovation and Development of Drugs and Medical Devices in Guangdong-Hong Kong- Macau Greater Bay Area can be found on our website here.

TAKE ACTION NOW

If you are a trader or supplier interested in supplying Class II/III/IV general medical devices or Class B/C/D in vitro diagnostic devices to DH Services, it is highly recommended to apply for MDACS listing as soon as possible. By being proactive and demonstrating your commitment to safety and quality, you position your company for success in the procurement process.

supplier, obtaining MDACS listing offers a competitive advantage in securing procurement opportunities, especially in the public sector. By acting now, you can position your company as a trusted supplier and contribute to the advancement of healthcare in Hong Kong.

Come Grow With Us 

Asia Actual has an office in Hong Kong staffed by experienced, bilingual regulatory and commercial professionals to address any questions or provide support. Please contact us to learn more about how our experts can provide your company with comprehensive support throughout the MDACS listing process, ensuring compliance with regulatory requirements and streamlining your access to DH procurement opportunities.

Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through independent license holding, direct fulfillment, and a variety of sales channel support services. 

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