Medical Device Registration Thailand

Our Services in Medical Device Registration Thailand

Quality Management System Development

  • Thai GMP for Medical Devices
  • Good Distribution Practice for Medical Devices (GDPMD)
  • ISO 13485:2016
  • Medical Device Directive (93/42/EEC) – CE Marking
  • In-Vitro Diagnostic Medical Device Directive (98/79/EC) – CE Marking
  • EU Medical Device Regulation (MDR 2017/745)
  • US Quality System Regulation (21 CFR Part 820)
  • Japan Quality Management System (J-QMS Ordinance)

Pre-Market Submission

  • Creation of Common Submission Dossier Template (CSDT) for manufacturer according to ASEAN MDD (AMDD)
  • Consolidation and/or interpretation/translation of Common Submission Dossier Template (CSDT) according to ASEAN MDD (AMDD) for Importer
  • Creation of Technical Documentation according to European Medical Device Directive (93/42/EEC)
  • Creation of Technical Documentation according to New EU Medical Device Regulation

Regulatory and Compliance

  • Import & Export Requirements
  • Device classification according to ASEAN MDD, EU MDD/MDR, US FDA
  • Contact/Liaise with EU Authorized Representative on behalf of Product Owner/Manufacturer
  • Labeling & Advertising Review
  • Product modification strategies and management