Regulatory Open Forum

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  • 1.  Asia pacific

    This message was posted by a user wishing to remain anonymous
    Posted 26-May-2021 07:45
    This message was posted by a user wishing to remain anonymous

    Over the past few years many of the countries in the AP region have either changed their regulations or have anounced their intention to update. Unfortunatly, because of COVID I am not sure where we are with the countries below. What I am looking for is the realistic registration tyimes and approximate regulator costs for registration. This could be as simple as 3-6 months and US$1000. The products are all Class IIa active.
    Also, I am seeing updates from several countries regarding the ASEAN Harmonisation but is this really happening.

    Vietnam*, Philippines, Hong Kong, Taiwan,Thialand*, Malaysia and India.

    * recently announced major reviews.

    Regards and thanks


  • 2.  RE: Asia pacific

    Posted 26-May-2021 10:56
    Registration in Hong Kong is free of charge and it is still in a voluntary basis.

    Sally Chan
    Regulatory Affairs Manager - EU, US, China

  • 3.  RE: Asia pacific

    Posted 02-Jun-2021 07:26

    Yes, you are right. In Asia-Pacific region, there are several countries issuing new guidelines recently.
    The ASEAN harmonized guidelines for MD, is already being implemented this year especially for Philippines & Thailand.

    In India, the new regulations, Indian MDR 2017 has been into force last year all the manufacturers located outside India or within India have started following them and receiving approvals.

    The approval time-lines would be 8 months to 1 year considering pandemic crisis and shortage of staff.
    Cost of registration varies for each country.

    Hope this information is useful !

    Purvi Goradia
    Manager Regulatory Affairs