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HONG KONG:  MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

HONG KONG: MDD Continues Trial to Accept Marketing Approval from NMPA China and MFDS Korea for Listing Application of Medical Devices in Hong Kong – August, 2021

  • 2021-08-30 01:11:33

The Medical Device Division (MDD) 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” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

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 PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

PHILIPPINES: PFDA Shares Guidance on Updated Registrable Medical Device List and Notification of Non-Registrable Devices

  • 2021-02-22 01:59:49

Recently, PFDA has shared two key guidance to the industry and stakeholders. FDAC 2020-001A updates the list of registrable medical devices while FDAC 2021-002 discusses the full implementation of medical device registration as per AO 2018-0002. The new guidance will have immediate impact the regulatory requirement for medical devices prior importing and selling in Philippines.

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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

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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