Manufacturing Certification Requirement in Thailand

Based on Ministerial Announcement No. 34 B.E. 2549 (2006), certain medical device importers in Thailand must submit, in addition to the required Certificate of Free Sale, proof of manufacturing quality of an imported product. Importers can submit either a GMP certificate or an ISO 13485 certificate to fulfill this requirement.

The following medical devices are required to submit this manufacturing quality certification:

  1. Implants
  2. Medical devices manufactured from tissue or tissue products
  3. Sterile medical devices
  4. Diagnostic radiation devices or radiation treatment devices
  5. Certain in-vitro diagnostic sets
  6. Sterilizing solution for medical devices
  7. Tooth filling and crowning materials

This regulation was implemented earlier this year.