Registration of medical devices is not mandatory in Hong Kong, but is a recommendation.
However, Hong Kong Department of Health (DH) will implement a new strategy for medical device procurement from June 21, 2023.
DH supports the Medical Device Administrative Management System (MDACS).
Under the new strategy, DH purchases medical devices to meet international standards-like safety, quality and performance requirements
In essence, monitoring safety warnings from the Medical Device Division (MDD) should provide additional protection for public health.
Therefore, it is recommended to register Class II/III/IV of general medical devices and Class B, C, and D of in vitro diagnostic medical devices with MDACS as soon as possible to supply medical devices to DH services.
For more information, please refer to the link below.
Department of Health | Medical Device Division - Department of Health to implement a new strategy on procurement of medical devi
Department of Health to implement a new strategy on procurement of medical devices Further to the pilot run on the procurement of medical devices (MDs) conducted earlier by the Department of Health (DH), DH will adopt a new strategy on the procurement of M
www.mdd.gov.hk
If you have any questions about medical device certification,
Please contact us with the below.
info@jnmglobal.net
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