The Hong Kong Medical Device Division (MDD) has announced that the “Essential Principles of Medical Device Safety and Performance” (Technical Reference: TR-004) will be available for use in the Medical Device Administrative Control System (MDACS) from 1 January 2024.
Hong Kong's existing reference countries were Australia, Canada, the European Union, Japan, and the United States, but as the information was updated, Korea and China were added as reference countries.
Accordingly, the following Guidance Notes and application forms have been updated.
Guidance Notes: GN-01, GN-02, GN-06
Application form: MD101, MD102
Products without a reference country approval are required to undergo local conformity assessment by one of the three Conformity Assessment Bodies (CAB) certified by the MDD. However, Chinese and Korean manufacturers can save 12 months on the registration process by allowing them to provide evidence of compliance with the MDD's assessment requirements using NMPA or MFDS approvals added as reference countries. Additionally, products with more than one reference country approval and no reportable adverse events qualify for Expedited Review of its registration application by the MDD. Thus the addition of South Korea and China to the reference country list increases the opportunity product registration applications to qualify for Expedited Review in Hong Kong.
Please refer to the link below for more information.
衞生署 | 醫療儀器科 - 醫療儀器行政管理制度動向 - 2024-01-01 (2317) (mdd.gov.hk)
衞生署 | 醫療儀器科 - 醫療儀器行政管理制度動向 - 2024-01-01 (2317)
由2024年1月1日起，醫療儀器科恆常接受由中國內地國家藥品監督管理局發出之銷售核准以支持醫療儀器符合醫療儀器行政管理制度（MDACS）“安全和性能基本原則”（技術參考：TR-004）。 此外，
www.mdd.gov.hk
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