Ministry of Health

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

Regulatory Authority

Medical Devices Control Division (MDCD)

Medical Device Regulation

• Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2)
• Medical Device Act B.E 2551 (2008)

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.