Regulatory Open Forum

 View Only

  • 1.  Thailand IVD Registration

    Posted 04-Aug-2016 05:34

    Hi

     

    I am trying to find out the process and classification for registering an in vitro diagnostic test for Tuberculosis in Thailand, Phillipines, Malaysia and Singapore.

     

    Please can anyone help.

     

    I was told that the Thailand FDA expected a GMP certificate from the country of manufacture, is this correct.

     

    Any help is much appreciated

     

    Fiona

     

    Fiona Rewcastle BSc Hons MRQA

    Quality and Regulatory Manager

    Epistem Ltd,

    48 Grafton Street,

    Manchester

    M13 9XX

     

    ( Tel:  +44(0)161 989 3153
    ( Fax: +44(0)161 606 7348

    * f.rewcastle@epistem.co.uk

    8  www.epistem.co.uk

    P Please consider the environment before printing this e-mail

     

    9A9A3B20-7824-4B1E-BBC0-5645144F8BF8

    Incorporated and registered in England and Wales under registration number: 03901952.  Registered office: The Incubator Building, Grafton Street, Manchester M13 9XX. VAT registration number: 903 0350 77.

    This email and any attachments and files are confidential and are intended only for the addressee(s). Any review, onward transmission, disclosure or other use of this email or any attachments by any other person is prohibited. If you receive this email and are not an intended recipient please inform the sender immediately and delete this message, removing any copies from your system. Unless expressly stated otherwise, any opinions expressed in this email or any attachments transmitted with it are personal and do not constitute the opinions of Epistem Holdings Plc or any subsidiary company (together "Epistem"). Although emails are routinely screened for viruses, Epistem does not accept any liability or responsibility for: (i) changes made to this email or any attachments transmitted with it after they were sent; or (ii) any viruses transmitted through this email or attachments transmitted with it. It is the responsibility of the recipient to ensure that the onward transmission, opening or use of this email or any files or attachments transmitted with it will not adversely affect its systems or data and the recipient should carry out such virus checks and other checks that it considers appropriate.

    For more information about Epistem please visit: www.epistem.co.uk

     



  • 2.  RE: Thailand IVD Registration

    Posted 08-Aug-2016 05:37

    Hi Fiona,

    Thailand IVD registration: At this moment, there is no difference between Medical device and IVD for registration in Thailand. It requires you to provide to your distributor, the legalized ISO 13485 certificate of the site, FSC/CFG, labels, IFU/User Manual to register with Thai FDA.

    Singapore: Registration is mandatory. You need to identify the classification of your IVD kit. There are multiple pathways to register an IVD in Singapore depending upon approval from GHTF (US, EU, Canada, Japan and Australia) Countries and # of years in the market and adverse events/recalls -full submission, abridged submission (for Class B, C, & D), expedited submission (Class B,C), Immediate approval (Class B).

    Malaysia: The Medical Device Authority has just made the regulations mandatory w.e.f 1 July 2016 and requires registration. You must have a local authorised representative (LAR/AR) in Malaysia, who is authorised to submit the CSDT (Common Submission Dossier -similar to EU Technical File). Also involves a 3rd party audit-either verification audit or a full conformity audit by a Conformity Assessment Body (CAB).

    Hope this helps!

    Regards,

    Sreenu

    ------------------------------
    Sattu Sreenu Babu
    Manager-Regulatory Affairs (APAC & Middle East)
    Cardinal Health
    Singapore
    sreenu.bme@gmail.com

    Original Message