Medical Device Registration in

Thailand

Ministry of Health

Ministry of Public Health – Thailand Food & Drug Administration (Thai FDA)

Regulatory Authority

Medical Devices Control Division (MDCD)

Medical Device Regulation

Official Language

Thai

Classification

Class I, II, III and IV

Registration Process

  • There are two processes involved – Product Registration (Listing/ Notification/ Licensing) & Dealer’s License
  • Product registration is to obtain marketing clearance for its import & supply in Thailand
  • Medical device dealers license can engage in the manufacture, import or wholesale of medical device in Thailand.
  • For Class I – Device Listing ; Class II & III – Notification ; Class IV – Licensing
  • Common Submission Dossier Template (CDST) format is needed for Class II, III and IV device registration

Documents Required

  • QMS certification
  • Application Form
  • Technical Document preparation
  • IFU, Label or User Manual
  • Letter of Authorization
  • Import License or Manufacturing license

Applicable QMS

ISO 13485

Registration Timeline

  • Class I – 200 days
  • Class II and III – 250 days
  • Class IV – 300 days

Authorized Representative

Yes

License Validity

5 years

Special Notes

Labels and IFUs should be in Thai and English.

 

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