Discussion: View Thread

  • 1.  DMF Submission in Malaysia, Thailand and Vietnam

    Posted 02-Mar-2021 16:27
    Hello Everyone

    I am working on a DMF submission for Asean Countries. Could anyone please share the guidelines specifically for Thailand and Vietnam to understand the DMF submission requirements in these countries. 

    I found few for Malaysia, if someone please help share the link for guidelines would be really appreciated.

    Thanks much 



    ------------------------------
    regulatory affairs
    ------------------------------


  • 2.  RE: DMF Submission in Malaysia, Thailand and Vietnam

    Posted 03-Mar-2021 14:09
    Hi Sonali,

    I found this to be a useful website as a starting point: https://www.pacificbridgemedical.com/regulation/asean-medical-device-pharmaceutical-regulations/

    I haven't got any further than an initial look into what's required for these countries.

    cheers,
    Beth

    ------------------------------
    Beth Gordon
    Systems Manager
    Christchurch
    New Zealand
    ------------------------------

    Original Message


  • 3.  RE: DMF Submission in Malaysia, Thailand and Vietnam

    Posted 04-Mar-2021 10:35
    Thank you Beth..

    ------------------------------
    regulatory affairs
    ------------------------------

    Original Message


  • 4.  RE: DMF Submission in Malaysia, Thailand and Vietnam

    Posted 15-Jun-2021 03:25

    Hi Sonali,

    I haven't seen this post until now. You can use international services like AA, AM, DKSH (PBM posted in the previous comment didn't work on this topic for a while, last time I emailed they about an ASEAN country they didn't reply).

    Yet for better understandings and quality, and more reasonable price I would recommend local services in each countries. The regulations in Vietnam have been experiencing rapid and major changes in the last few years so you need someone in country. Let me know if you still need recommendation.



    ------------------------------
    Thuy, Tran Thanh (Ms)
    Independent consultant, Regulatory Affairs & Quality Assurance
    Auditor ISO 9001:2015 (certified by CQI and IRCA) and 13485:2016
    Hanoi, Vietnam
    ------------------------------

    Original Message