Regulatory Affairs Update: Singapore

Singapore: HSA’s Registration Approvals Recognised by Hong Kong MDD for Class II / III / IV Listing in Hong Kong

Medical device companies can use the registration approvals accorded by the Health Sciences Authority (HSA) of Singapore to enter the Hong Kong market starting 02 April 2024. The HSA issued this information via the April 2024 Nexus Newsletter.

This means that valid registration approvals could be used to demonstrate conformance to the Essential Principles of Safety and Performance of Medical Devices in support of Class II/III/IV General Medical Device and In Vitro Diagnostic Medical Device Listings with the Hong Kong Medical Device Division (MDD).

Further information can be accessed in the Nexus Newsletter here on page 9 (nine).

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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