Asia Actual Hong Kong

Eric Leung
Asia Actual Hong Kong

“We recommend that medical device manufacturers participate in the voluntary registration process in Hong Kong for sales purposes and to beat the rush that will accompany mandatory registration.”

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Did you know that you can use R.O.S.E. to search what products are registered in Hong Kong?

It also allows you to search registered products in Singapore, Malaysia, Indonesia, Philippines, and Australia with more markets coming soon.

Hong Kong to Pilot Prioritizing Some Listed Medical Devices

Published on August 30, 2022

Listed Devices to be Given Tender Preference by Department of Health

In an email sent to stakeholders on August 29, 2022, Hong Kong’s Department of Health (DH) announced the start of a pilot program that will give preference to Medical Device Administrative Control System (MDACS) listed medical devices. The pilot program applies to public tenders for which the Department of Health (DH) is procuring the medical devices.

Per the new guidance:

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.

Further outlined on their website, the MDD plans to start with a specific list of medical devices including, condoms, lubricants of Class II or above, blood glucose meters, and blood glucose strips. The pilot program will begin on October 1, 2022 and depending on the outcome, the program will be expanded to additional product categories.

Procurement Requirements

At this time, the Department of Health will only show preference to listed products and recommends that manufacturers and local traders submit applications as soon as possible to maintain tender competitiveness. During the tender process, listed medical devices will be given an additional score which could win the tender should there be other products being considered not on MDACS.

Tender participants will need to show proof of MDACS listing by providing the HKMD listing number and a valid copy of the Certificate of Listing under MDACS.

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 that wish to sell to the public hospitals should seek registration and listing on MDACS. It is also expected that registration will eventually become mandatory and therefore, by registering now, manufacturers can avoid potential long review times when implemented.

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. This tool is available here.

Expedited Approval Options

The Expedited Approval Scheme is meant help improve the review process in Hong Kong as review timelines increased the last couple of years. Class II, III, and IV products approved by any 2 of the following markets are eligible for a quicker review:

  • 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:

  1. any reported deaths or serious injuries associated with the device (locally and worldwide)
  2. any active recalls, field safety corrective actions or adverse events (locally and worldwide)

For more information on the expedited review routes in Hong Kong, please see our blog on the topic here.

For more information on market access in Hong Kong, please see our page on the topic here.

Overview of the Hong Kong Registration Process

Medical Device product registration in Hong Kong is managed by the Medical Device Division (MDD) of the Department of Health, formerly known as the Medical Device Control Office (MDCO). Currently, medical device product registration is voluntary in Hong Kong for Class II and above medical devices and Class D IVD devices.

Even though registration is currently voluntary, the Hospital Authority requires, or gives preference to, registered medical devices during public hospital tenders. Registered medical devices will be listed on the Medical Device Administrative Control System (MDACS).

While manufacturers can use a Conformity Assessment Body (CAB) to review their technical documents, most manufacturers will leverage Reference Country approval(s) to expedite market access. ISO 13485 or equivalent is also required and listings are valid for 5 years with an administrative review.

For the latest registration information, including timelines and fees, see our Medical Device Registration page.

Grow with Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions related to medical device registration in Hong Kong or throughout the region.

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