On 30 September 2024, the Medical Device Division (MDD) of Hong Kong introduced an updated procedure for processing renewal applications...

On the 4th of July 2024, the Department of Health (DH) announced its movement towards the second phase in enhancing the measures of...

The Pharmacy and Poisons Board of Hong Kong (“the Board”) announced that the Refuse-to-File (“RTF”) Mechanism will be enforced in the...

Overall responses from full and thorough jurisdictions based on the current situation in Hong Kong and public consultation led by the...

Medical Device Division (MDD) of Hong Kong introduced a new one-stop e-service platform for online application submissions for medical...

Australia: Proposed changes to the Essential Principles for safety and performance Australia: Proposed changes to the requirements for...

Listing of LRP Hong Kong's Medical Device Control Office (MDCO) has plans to issue new Guidance Notes on the Listing of Local Responsible...

AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...

MDCO has proposed a trial scheme for provisional approvals of Class II/III/IV Medical Devices. A list of criteria has to be fulfilled...