Overseas Marketing Approvals for Listing Medical Devices in Hong Kong

On 22.01.2020, the Hong Kong MDD (Medical Device Division) announced the continuance of the pilot phase to study the feasibility for LRP (Local Responsible Persons) to apply the MDACS listing of Class II/III/IV general medical devices in Hong Kong by presenting valid marketing approvals obtained from the China NMPA (National Medical Products Administration). The trial started on 01.06.2018, and will last until 31.12.2020.

Currently, there is also another pilot phase that will last until 31.03.2020 for the MDACS listing of Class II/III/IV general medical devices in Hong Kong by presenting valid marketing approvals obtained from the Ministry of Food and Drug Safety of Korea. Other overseas marketing approvals may also be considered applicable in Hong Kong. Consult us to know more.

On 06.11.2019, the Central Government of PRC has accepted the HKSAR government’s proposal for the use of Hong Kong registered pharmaceutical products and common medical devices in designated Hong Kong-owned medical institutions in the Greater Bay Area.

As a facilitation measure for Hong Kong residents working and living in the Greater Bay Area to seek healthcare services, it will help attract local and multinational pharmaceutical, biomedical and health technology companies to introduce medical devices to Hong Kong with a view to expanding their businesses in Hong Kong and Mainland cities in the Greater Bay Area, benefiting patients in both places.

The Food and Health Bureau will be in discussion with relevant Mainland authorities on the implementation details, including the measure at the University of Hong Kong-Shenzhen Hospital on a pilot basis.

Learn more about how Cisema can support you with the Hong Kong MDACS registration.