Regulatory Open Forum

 View Only

  • 1.  medical device registration Hong Kong

    Posted 12-Jul-2021 23:40
    I know that registration is not mandatory in HK but because our products go through hospitals, I need to register a Class II active device.
    I am have trouble getting any up to date information about the registration process. The product is already registered in the EU and Australia so my questions are:
    • Will the above two registrations be used as evidence of conformity assessment in the registration process.
    • How long does it take.
    • What are the main steps. Most published pathways are from 2019 or older and I know that HK was in the process of major changes.
    • I have not been successful in working my way through the MDD to look at the registration forms .... help needed.
    Regards


    Barry

    EBR consulting Services.

    ------------------------------
    Barry Evers-Buckland
    Director
    Eltham North VIC
    Australia
    ------------------------------


  • 2.  RE: medical device registration Hong Kong

    Posted 13-Jul-2021 02:10
    Dear Barry

    Hong Kong listing with MDACs is relatively straightforward compared with China Mainland (and voluntary, as you point out). You can read more about it here: https://www.cisema.com/en/services/certification/hong-kong-mdacs-registration/. 

    It is also more interesting recently as a potential pathway into selling into China Greater Bay Area (GBA), as Hong Kong listing and sales in Hong Kong will enable potential acceptance in GBA of products even if not registered with NMPA.

    Regards
    Hamish
    hamish.king@cisema.com

    ------------------------------
    Hamish King
    Hong Kong
    hamish.king@cisema.com
    ------------------------------

    Original Message


  • 3.  RE: medical device registration Hong Kong

    Posted 13-Jul-2021 05:08
    Hi Barry,

    Main information can be found in the Medical Device Division website (https://www.mdd.gov.hk/en/home/index.html) or you can contact them, they are nice and give feedback. Also the MDD is frequently providing workshops on this topic, check for new dates here https://www.mdd.gov.hk/en/whats-new/events/index.html.
    I agree with Hamish that the process is relatively straightforward compared with China Mainland, currently the main delays are related to the allocation of resources due to Corona pandemic.

    Regards,

    ------------------------------
    Emilia Spallanzani
    QA&RA Manager
    Germany
    ------------------------------

    Original Message


Related Content