Hong Kong boasts a wealthy and sophisticated medical device market. It relies heavily on imported medical devices to meet the needs of its country, due to the low production of local medical devices. Besides, Hong Kong is also fast becoming an aging nation, and along comes all the aging-related ailments increase, according to the information from the Census and Statistics Department of Hong Kong, total population aged over 65 years is deemed to grow even further in the coming years.
Due to the growing numbers in its aging society, the need for medical devices, especially those corresponding to age-related ailments such as non-communicable disease treatments, rehabilitative treatments, and home-use medical devices, is also seeing an uphill trend. Furthermore, there are also plans for a 10-year Hospital Development with government funding of approximately $500 billion in Hong Kong, inviting foreign manufacturers from all around the globe. [4]
In addition to that, on 25 November 2020, a program called "Guangdong, Hong Kong, Macao and the Bay Area Drug Medical Device Regulatory Innovation and Development Work Program." determined by Guangdong Provincial People's Government, was newly launched. With this new program, maintenance of the national drug and medical device regulatory system between Guangdong, Hong Kong, and Macao are expected to be combined to establish an institutional mechanism for listed pharmaceutical medical device of Hong Kong and Macao in the Mainland Guandong hospital by 2022. [6] This will further boost the medical device sector in Hong Kong in the coming years.
- - Hong Kong’s regulatory system
The Medical Device Division (MDD), formerly known as Medical Device Control Office (MDCO), was established in July 2004. The MDD is responsible for implementing the Medical Device Administrative Control System (MDACS) and developing a long-term regulatory framework for medical devices in Hong Kong.
The MDACS has adopted the classification rules by the IMDRF and classifies general medical devices into four classes (Class I, II, III and IV). Registration of medical devices in Hong Kong is voluntary for medical devices with risk classes II, III, and IV and IVD products of risk class B, C, and D. Class I general medical device or Class A IVD product can be directly supplied to Hong Kong market without prior registration.
Although registration of medical devices in Hong Kong is voluntary, it should be noted that hospitals in Hong Kong prefer to purchase medical devices which have been safety and performance evaluated and listed in MDCAS.
- - Medical Device Administrative Control System (MDACS) registration
Registration of medical devices in Hong Kong will be overseen by the Medical Device Division (MDD) and will be listed on Medical Device Administrative Control System (MDACS). Medical Device Administrative Control System (MDACS) features both a listing system for medical device and an adverse event reporting system.
The following is a summary of the medical device registration workflow:
A. Preparation of documents to fill up the application form before submitting to Medical Device Division (MDD).
B. The appointed Local Responsible Person (LRP) submits the application to the Medical Device Division (MDD), in the form of hardcopy or softcopy. However, MDD encourages to submit by soft copy method by only submitting soft copy of required document in CD-ROM and hardcopy for the application form only.
C. MDD conducts preliminary evaluation to check completeness of the documents before entering the review stage.
D. Application review for lists of medical devices is officially completed within 12 weeks of application submission. This timeline exclude condition where application might get review comments from the evaluator.
E. The approval certificate is obtained, and the device could be marketed in Hong Kong. The validity of approval certificate is five years from the date of issuance.
- - Acceptance of Prior Marketing Approval granted by NMPA
On 24 December 2020, MDD announced to continue trial to accept marketing approval obtained from the National Medical Products Administration (NMPA) of China and the Ministry of Food and Drug Safety (MFDS) of Korea for listing application of medical devices under the Medical Device Administrative Control System (MDACS). Thus, for applicant who provides marketing approvals from NMPA / MFDS, they can proceed the application without providing the Medical Device Administrative Control System (MDACS) conformity assessment certificate issued by one of the Conformity Assessment Bodies (CAB).
This announcement will be valid from 31 December 2020 to 31 June 2021. Please refer to this link for the announcement.
Apart from that, MDD Hong Kong also continues Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications until 31 December 2021. As for some of the requirements that must be met by the applicant are as follows:
a. There are no reported deaths or serious injury associated with the device (local and worldwide)
b. There are no active recalls, field safety corrective actions or adverse incidents (local and worldwide)
c. Two or more valid, independent regulatory agencies’ approval have been obtained for at least three years
Note: “Independent regulatory agencies’ approval” means the status of a marketing approval document that is not dependent on the approval status of another marketing approval document.
As Hong Kong continues to dazzle as a fast-growing medical device market in Asia, we may help you seize the opportunity to enter this market by registering your medical devices, as well as assisting you to connect with local distributors – ultimately, leading you to a smooth journey towards the expansion of your products into the Hong Kong medical device market.
References:
[1] Healthcare Resource Guide: Hong Kong (2018) by International Trade Administration
[2] Industry Overview Medical Devices by Frost and Sullivan
[3] Promising Prospects for the Life Science Industries
[4] Budget 2020-21 Highlights Hong Kong
[5] Hong Kong Population Projection
[7] Overview of the Medical Device Administrative Control System
[8] Guidance Notes for Listing Class II/III/IV Medical Devices