Quality System Overview

Thai FDA · MDCD · ISO 13485 · Medical Device Act B.E. 2562

Who Needs a QMS

Entity	Requirement
Foreign manufacturer (Class 2–4)	ISO 13485 certificate — mandatory for CSDT submission
Domestic manufacturer (Class 2–4)	Thai GMP compliance or ISO 13485 — MDCD manufacturing licence required
Importer / license holder	GDP-aligned storage and distribution system
Class 1 establishments	Thai GMP guidelines apply; certification not required

ISO 13485 Requirement — Class 2–4

Since July 2024, ISO 13485 (or TCAS 13485 — the Thai equivalent) or GMP certificate is mandatory for all Class 2, 3, and 4 device registrations. The certificate must:

• Be issued by an internationally accredited certification body (IAF/ILAC recognised)
• Cover the specific product category being registered — check that the scope matches
• Be current at time of CSDT submission
• Remain valid throughout the registration period — submit updated certificates at renewal

Thai FDA recognises internationally issued ISO 13485 certificates without requiring a separate Thai certification.

Thai GMP — Domestic Manufacturers

Thai manufacturers of Class 2–4 devices must obtain a MDCD manufacturing licence, which requires demonstrating GMP compliance. Thai GMP requirements are aligned with ISO 13485 principles and cover:

• Facility design and controlled environment
• Equipment qualification and calibration
• Personnel competency and training records
• Document control and batch record systems
• Process validation (for sterile / critical-performance devices)
• Supplier qualification
• Internal audit programme
• CAPA system
• Management review

See MDCD Inspections for the on-site inspection process.

GDP for Importers and License Holders

Importers and license holders must maintain good distribution practice covering:

• Appropriate storage conditions (temperature and humidity monitoring where required)
• Segregation of approved, quarantined, rejected, and recalled stock
• FIFO stock rotation to prevent expiry
• Traceability from receipt to customer delivery
• Distribution record maintenance

Thailand does not yet have a standalone GDPMD regulation but expects standards aligned with WHO Good Distribution Practice.

QMS in the CSDT

ISO 13485 evidence is submitted in the QMS section (Section 9) of the CSDT for all Class 2–4 registrations. At renewal:

• Submit a current ISO 13485 certificate (not expired)
• If the manufacturer has changed certification body, confirm the new certificate covers the same product scope
• Notify Thai FDA/MDCD if the manufacturer's ISO 13485 certification is suspended during the registration period

Key QMS Elements for All Entities

Element	Importer / License Holder	Manufacturer
Complaint handling system	Required	Required
Distribution records	Required	Required
FSCA / recall procedures	Required	Required
Adverse event reporting procedures	Required	Required
Risk Management Plan	Required	Required
Internal audit	Recommended	Required
CAPA system	Recommended	Required