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HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

  • 2024-09-17 03:42:57

The Expedited Approval Scheme for Medical Device Listing Applications has been expanded to include Class B/C/D In Vitro Diagnostic Medical Devices. Eligibility criteria remain unchanged, while some additional regulatory agencies have been recognized. Applications must be submitted through Medical Device Information System and refers to both GN-02 and GN-06.

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THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

  • 2022-04-27 11:27:43

In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device, which has been effective since 1st March 2022.

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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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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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