HONG KONG: Keeping Up with the MDACS - The Exclusion of Particular Devices and HSA Marketing Approval Acceptance – June/July 2024

• 2024-06-19 06:31:24

Starting 13 May 2024, Hong Kong Medical Device Division has excluded non-clinical devices from Medical Device Administrative Control System’s scope. Custom-made medical devices have also been excluded from this scope since 2 April 2024, and marketing approvals from Health Sciences Authority - Singapore has been accepted to support listing applications.

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香港：維持受理韓國MFDS關於MDACS的市場批准的要求 - 2020年4月

• 2020-04-14 01:28:54

醫療器械部將繼續進行試驗，以研究當地負責人（LRP）證明其醫療器械符合“醫療器械安全和性能的基本原則”的可行性。

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香港：MDACS繼續接受從中國獲得的醫療器械上市申請的營銷批准 - 2020年3月

• 2020-03-16 06:42:41

醫療器械部門將繼續進行試驗，以研究對當地負責人（LRP）的可行性，該試驗將持續到2020年12月31日，以用於有限數量的II / III / IV級普通醫療器械的上市申請。

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