Bryan Gilburg - China

“Hong Kong is establishing a path for mandatory registration that will likely be more aligned with the MFDS.”

Bryan Gilburg

Managing Director

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

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Hong Kong Prepares Office for Mandatory Medical Device Regulations

Published on: June 13th, 2024

On June 5th, Hong Kong’s Department of Health (DH) announced plans for the establishment of the Centre for Medical Products Regulation (CMPR). The entities first task will be to investigate changes to regulatory and approval processes for medical devices and drugs in Hong Kong. The territory has had a voluntary regulatory system in place for medical and invitro diagnostic devices since 2004. Any new systems are likely to be more closely aligned with regulatory systems managed by the NMPA in Beijing.

Hong Kong’s Approach to Medical Product Registration

In the 2023 Chief Executive Policy Address, the Government outlined plans to establish an authority that registers drugs and medical devices under the “primary evaluation” approach. According to the HKSAR Official Press Release, primary evaluation is:

to directly approve applications for registration of medical products in Hong Kong based on clinical trial data, without relying on registration approval from other drug regulatory authorities.

According to Hong Kong, the primary evaluation approach is expected to increase the clinical use of new drugs and medical devices while simultaneously bolstering the industry’s growth. Hong Kong’s aspiration in this restructuring is to position itself as a globally renowned hub for medical innovation and progress.

Hong Kong’s Regulatory Roadmap

The preparatory office will study and plan a regulatory and approval system suitable for Hong Kong with support from the National Medical Products Administration (NMPA) of China. Around 2026 or 2027, the CMPR should be fully established and followed by an implementation period of the primary evaluation approach. Additionally, Hong Kong expects to secure membership in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

HKDH Already Seeing Results

The Government introduced a new drug approval mechanism, known as the “1+” mechanism, on November 1, 2023 (See the full HKSAR Press Release). This mechanism allows holders of registration from one recognized drug regulatory authority (instead of two) to apply for drug registration in Hong Kong, so long as they can furnish local clinical data meeting local experts’ requirements. Since its inauguration, two new cancer treatment drugs have already been approved for registration.

HKDH Introduces the MDIS

The HKDH has also announced the launch of the Medical Device Information System (MDIS)- an online medical device registration platform. With paper submissions phasing out from June 17, 2024, stakeholders are encouraged to register early on the MDIS website.

Should you need support in this transition or have other questions regarding medical device registration in Hong Kong, please contact us.

Come Grow With Us

Please contact us if you’d like support understanding these new requirements or are interested in registering your product in Hong Kong. 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 or support requests.

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

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