MDCD Inspections
Thai FDA · MDCD · Establishment License · GMP compliance
Overview
The Thai FDA's Medical Device Control Division (MDCD) inspects establishments — manufacturers, importers, and distributors — to verify compliance with GMP, GDP, and post-market obligations. Inspections may be routine (part of licence cycles) or triggered by adverse events or complaints.
Types of Inspections
| Type | Who | Trigger |
|---|---|---|
| Manufacturing licence inspection | Domestic manufacturers | Part of manufacturing licence application and renewal |
| Establishment License inspection | Importers, distributors | Part of Establishment License process |
| Market surveillance inspection | License holders, importers | Routine — ongoing monitoring |
| Complaint-triggered inspection | Any establishment | Following adverse event, FSN, or complaint |
| Import inspection | Importers | At port of entry (spot checks) |
Manufacturing Licence Inspections
Before issuing a manufacturing licence to a domestic manufacturer, MDCD inspectors conduct an on-site GMP inspection assessing:
- Facility design, environmental controls, and contamination prevention
- Equipment qualification, calibration, and maintenance records
- Personnel training and qualification
- Document control and batch record systems
- Production and process controls (including validation for sterile devices)
- Supplier qualification and incoming inspection
- Quality control laboratory capabilities
- Internal audit programme and CAPA records
A manufacturing licence is issued only once the facility demonstrates satisfactory compliance. Critical deficiencies require remediation and re-inspection.
Establishment License Inspections
Importers and distributors holding an Establishment License may be subject to inspection verifying:
- Valid Establishment License and compliance with licence conditions
- Storage conditions (temperature and humidity monitoring for applicable devices)
- Distribution record completeness and traceability
- Complaint handling and adverse event reporting records
- Validity of all device registrations held
Market Surveillance
MDCD conducts periodic market surveillance throughout Thailand, including:
- Inspection of licensed establishments
- Sampling of devices from the market for testing
- Checking labelling compliance (Thai language requirement for home-use devices)
- Verifying that distributed devices are covered by valid registrations
Responding to Inspection Findings
When MDCD identifies deficiencies:
- Written deficiency notice is issued
- Establishment must prepare and submit a CAPA plan within the specified timeframe
- MDCD may conduct a follow-up inspection to verify CAPA implementation
- Unresolved findings may lead to:
- Suspension of Establishment License or manufacturing licence
- Revocation of device registration
- Seizure of non-compliant products
- Criminal prosecution under the Medical Device Act B.E. 2562
Maintaining Inspection Readiness
- Keep all licences, registrations, and ISO 13485 certificates current and filed accessibly
- Maintain distribution records for each product and lot
- Ensure the complaint log is up to date with documented investigation outcomes
- Conduct internal audits at least annually — address findings before MDCD visits
- Train all relevant staff on inspection cooperation procedures