China GBA 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 before China NMPA approval, the products need to be used in Hong Kong. The Hong Kong Department of Health (DH) is implementing a new medical device procurement policy, effective from June 21, 2023.
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.
If you have any questions about HK medical device registration and GBA early commercialization, please email me.
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Grace Fu
China Med Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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