China’s Greater Bay Area is one of the most affluent and populated regions with close to 86.17M people, more than the entire size of Germany. To sell in GBA Hong Kong medical device needs China NMPA approval beforehand, the products need to be used in Hong Kong or Macau public hospitals. The Hong Kong Department of Health (DH) is implementing a new medical device procurement policy, effective from June 21, 2023.
Hong Kong New Procurement Policy
This policy prioritizes Medical Device Administrative Control System (MDACS)-listed medical devices, covering Class II/III/IV general medical devices and Class B/C/D in-vitro diagnostic medical devices.
This approach aims to ensure DH’s purchases meet international safety and quality standards. It also benefits from safety monitoring mechanisms and adverse event reporting.
Manufacturers seeking to supply DH with medical devices are encouraged to list their products under MDACS. Simultaneously, the Medical Device Control Office (MDC) requires more application reviewers preparing for mandatory medical device registration.
Early registration offers direct access to leading hospitals via the Greater Bay Area Program.
Urgent Use Program for GBA Hong Kong Medical Device
While not-yet-approved in the mainland, Hong Kong or Macao approved drugs and medical devices can be utilized in GBA. They can be used only if the significant clinical benefits with urgent needs can be demonstrated. Guangdong provincial NMPA will decide on import approval within 20 working days.
Eight devices have been added to the third batch of devices in late 2022, designated as urgently needed, published by Guangdong Health Commission:
- bioMerieux: FilmArray Torch (System Base/ Module/Empty Torch Bay Front cover FRU Kit)
- bioMerieux: BioFire BCID2 Panel
- bioMerieux: BioFire Respiratory Panel 2.1(RP2.1)
- bioMerieux: FilmArray Pneumonia Panel Plus (Pneumoplus)
- Medtronic: TYRXTM Absorbable Antibacterial Envelope
- Dutch Ophthalmic Research Center: Posterior segment staining solution
- Dutch Ophthalmic Research Center: Anterior segment staining solution
- Terumo: Thoraflex Hybrid System
If you have any questions about HK medical device registration and GBA early commercialization, please email us at info@ChinaMedDevice.com.