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Hong Kong: "1+" Mechanism Guidance for Faster Approvals
Since 1 November 2023, Hong Kong has embraced the “1+ mechanism” , a progressive pathway for registering new drugs. Under this system,...
ARQon
Aug 142 min read
Hong Kong: DH Sets Timeline for CMPR and Primary Evaluation Framework
In a strategic move to become a global hub for healthcare innovation, the Department of Health (DH) has announced a detailed timetable...
ARQon
Jul 162 min read
Hong Kong: Revised Guidelines for Processing Application Renewal of Listed Medical Device (w.e.f 1 January 2025)
On 30 September 2024, the Medical Device Division (MDD) of Hong Kong introduced an updated procedure for processing renewal applications...
ARQon
Oct 8, 20241 min read
NGBA: Latest Import Regulations for Drugs and Medical Devices from Hong Kong and Macao into the 9 Cities of the Greater Bay Area (w.e.f 1 December 2024)
The Standing Committee of the 14th Guandong Provincial People’s Congress has adopted revised regulations for managing the importation of...
ARQon
Sep 10, 20242 min read
Hong Kong: Enhanced Measures Announced by DH for Medical Device Procurement Strategy
On the 4th of July 2024, the Department of Health (DH) announced its movement towards the second phase in enhancing the measures of...
ARQon
Jul 24, 20242 min read
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