HONGKONG: Continuity of trial scheme for expedited approval of Class II/III/IV general medical device listing applications – August, 2020

• 2020-08-11 05:46:22

The Medical Device Division (MDD) Hongkong will continue the trial scheme to simplified application and approval process of Class II/III/IV general medical device listing applications with established support on proven safety and performance.

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HONGKONG: Continuance of trial to accept marketing approval obtained from the Korea MFDS regarding MDACS - April, 2020

• 2020-04-14 01:28:54

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” .

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HONGKONG: Continuance of trial to accept marketing approval obtained from the National Medical Products Administration for listing application of medical devices under the Medical Device Administrative Control System (MDACS) - March, 2020

• 2020-03-16 06:42:41

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices. 

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