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  • 1.  CE marked products

    Posted 08-Jun-2017 04:20

    Hi,


    I would really like some guidance on strategies to market medical devices in south east Asian countries (such as Hong Kong, Taiwan, Vietnam) once a CE marked is approved for a medical device. I have been reading online and its not clear how straightforward the process is post the CE mark approval. Would just a registration of the device be sufficient or based on the classification of the medical device, the marketing can differ from a simple registration to a full regulatory approval. Please if someone has the expertise in this, I would really appreciate some guidance. Thanks.



    ------------------------------
    Harsha Gupta
    Regulatory Affairs Manager
    Orthocell Ltd.
    Murdoch Western Australia WA
    Australia
    ------------------------------


  • 2.  RE: CE marked products

    Posted 08-Jun-2017 04:33
    Hello Harsha,

    HK - Its voluntary registration for medical devices in HK.
    TW - If Class 1, no Quality System Documentation(QSD) approval is required; if Class 1sterile, 2 and above, the first step is to obtain QSD approval; followed by product registration. It takes 9-12months and again it depends on your product risk classification. With CE marking, no expedited process is available.
    Vietnam - With effect from Jan 2018, new medical device regulations will be implemented; so need to start submitting ur registration docs in July/Aug timeframe.

    Hope this helps!

    Regards
    Sreenu

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    SATTU Sreenu
    Regulatory Affairs Manager
    Singapore
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    Original Message


  • 3.  RE: CE marked products

    Posted 08-Jun-2017 21:46
    Thank you so much for that Sattu. I really appreciate it. I am quite certain that this would be same for Malaysia, Thailand and Singapore as well, right? Our product is generally a Class 3 (sterile) product in most jurisdictions and as such he CE mark product wouldn't get us any shortcuts for regulatory approval.

    ------------------------------
    Harsha Gupta
    Regulatory Affairs Manager
    Orthocell Ltd.
    Murdoch Western Australia WA
    Australia
    ------------------------------

    Original Message


  • 4.  RE: CE marked products

    Posted 09-Jun-2017 00:11
    Hi Harsha,

    For Malaysia: If CE mark, then the Conformity Assessment Body (CAB) assessment is just "verification" rather than full assessment.
    For Singapore: if one regulatory agency (from GHTF members), then it will be abridged submission pathway.
    For Thailand: CE mark does not matter for registration.

    Regards
    Sreenu
    Original Message


  • 5.  RE: CE marked products

    Posted 09-Jun-2017 10:19
    Hello Harsha,

    The requirements can differ in these countries regardless of whether you have a CE mark or not.  Hong Kong currently has voluntary registration so you can actually get into the market without registering your device but it is strongly recommended.  Taiwan has very complex regulatory requirements for registration as well as QMS requirements and may require clinical data based on your device classification.  Vietnam also implemented new regulations for medical devices recently where registration for all imported medical devices is now mandatory.  The classification pathway may vary in each country. That being said, you can definitely leverage your CE technical documentation to complete the registration dossiers for these markets, but there may be additional requirements or tests you may need to do, for instance, EMC & electrical safety, sterilization, biocompatibility, or performance characteristics for IVDs.  There are also additional labelling requirements. Hope this helps.

    ------------------------------
    Maham Ansari MS RAC
    Director, Regulatory Affairs
    Synaptive Medical
    Toronto ON

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    Original Message


  • 6.  RE: CE marked products

    Posted 11-Jun-2017 22:39
    Dear Maham,

    Thanks a lot for your assistance and the detailed information. Much appreciated.

    ------------------------------
    Harsha Gupta
    Regulatory Affairs Manager
    Orthocell Ltd.
    Murdoch Western Australia WA
    Australia
    ------------------------------

    Original Message


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