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Thailand: Thai FDA Streamlines Medical Devices Registration Pathway (w.e.f 6 June 2024)

Effective 6 June 2024, the Thailand Food and Drug Administration (TFDA) has executed the new announcement on the registration simplification of medical devices registration. This is in accordance with the specifying data, evidence, or documents that are not obligated for submission under the Ministerial Regulations concerning the permission and issuance of licenses for manufacturing or importing medical devices, as well as the notification license and issuance of listing certificates for the manufacturing or importation of medical devices, B.E (2024).


Following the announcement, a few paperwork were exempted from the document submission. There are 2 registration pathways involved with the announcement: Full Pathway and Abridged Pathway.


1. Full Pathway

Manufacturers or importers were offered 3 options for the evaluation process including quality, performance, and safety:

2. Abridged Pathway

This option is only available for medical devices with approval from reference countries (authorized agencies), which are:

  • Australia (Therapeutic Goods Administration)

  • Canada (Health Canada)

  • Europe (European Union Notified Bodies)

  • Japan (Ministry of Health Labor and Welfare (MHLW)

  • United States of America (US FDA)

  • World Health Organization (WHO)


Besides, medical devices to be registered must have an approval history or registration from any reference agencies.

 

Please refer to the table below for the latest adjustment on the document exemptions:

Please note that these exemptions and simplifications do not apply to the medical devices listed under the assessment exemption from reference countries (ex: Listing or Exempted Product Approval).



Contact us at info@arqon.com for more information.

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