Regulatory Open Forum

 View Only
  • 1.  Asian approvals

    Posted 02-May-2012 22:44
    We have a Class 1 approved device in the EU and Australia with the TGA. Can anyone provide me with details or web sites to visit for the following countries, HK, Singapore, Korea China and Japan. If possible an indication of registration costs would be helpful.
    Many than thanks

    Harry Pose
    Managing Director
    Spectrum Technology Pty Ltd

  • 2.  RE:Asian approvals

    Posted 03-May-2012 22:49
    Hi Harry,

    Firstly, if a product is Class I in EU and Australia, it doesn't mean it would be the same Class in other countries, as you might be aware of this!!

    For Hong Kong: It's a voluntary registration, so you can supply the product in HK.
    SG: From 1 May 2012, Class A products are exempted from product registration. Assuming the product in SG as Class A, based on Class I in EU; however, the final classification will be detemined by the intended use of the product by you.
    If Class A, so no registration and no fees. The importer or the manufacturer has to update the list of Class A medical devices, every six months.
    Korea: If Class I, it requires product notification license and takes a month or so with a cost around USD1500.
    If Class II, it requires type testing and product approval license and may take 6-9 months and approximately costs from USD 5000-8000(type testing: USD800-1500; registration approval:USD 3500-5000).

    The other important thing is KGIP Certification inspection at the importer site. Also involves fees.;jsessionid=yhbPfs8ksvMr12iyF8VT2T71o6qjwZ4hbd1eMwDLbJislm6feZvSONc2BRYggkZj

    Japan: If class A in EU and Australia, assuming it falls under General Medical Device Category, it requires notification to PMDA and no fees(If I am not wrong!!) and may take a week or less to get listed with PMDA register.

    China: Requirements include product description, ISO 13485 cert from the manufacturing site, Validation (SW, design and field test) test reports, labels, English User Guide, Chinese User Guide, Declaration Letters(6-9), Free Sales certificate from the Country of Origin.
    Involves local type testing, so you need to ship an instrument.
    I am not sure of the cost correctly, however, roughly it may be 8-10K USD including translation of user guide into Chinese and process takes roughly 12-14 months.


    Sattu Sreenu Babu
    Sr. Regulatory Engineer
    Life Technologies