Thailand Ministerial Regulation on Medical Device Establishment Registration (2009)

1. Legal Basis and Effective Date

The Ministerial Regulation on Medical Device Establishment Registration was issued on 19 November 2009 under the authority of Section 6 and related provisions of the Medical Devices Act B.E. 2551 (2008). https://en.fda.moph.go.th/media.php?id=482374780499140608&name=20091119%20Ministerial%20Regulation%20on%20Medical%20Device%20Establishment%20Registration.pdf It became effective thirty days after publication in the Government Gazette and remains a foundational requirement for operating in the medical device supply chain in Thailand.

2. Purpose and Scope

The Regulation aims to control and ensure the quality, safety, and efficacy of medical devices by mandating registration of all establishments involved in production, importation, or distribution. It applies to:

• Manufacturing premises
• Import warehouses and facilities
• Distribution centers and wholesale operations
• Any other entity handling medical devices commercially https://en.fda.moph.go.th/media.php?id=482374780499140608&name=20091119%20Ministerial%20Regulation%20on%20Medical%20Device%20Establishment%20Registration.pdf

3. Registration Requirements

Establishments must apply for registration with the Thai FDA and meet specified criteria, including:

• Suitable location, building structure, and environmental controls to prevent contamination or damage.
• Adequate space for receiving, storage, inspection, quarantine, and dispatch.
• Proper equipment for handling, cleaning, and environmental monitoring (especially temperature/humidity for sensitive devices).
• Qualified personnel with defined responsibilities.
• Written procedures and records for operations, maintenance, and quality assurance. https://en.fda.moph.go.th/media.php?id=482374780499140608&name=20091119%20Ministerial%20Regulation%20on%20Medical%20Device%20Establishment%20Registration.pdf

4. Application Process

• Submit application form with floor plans, equipment lists, personnel details, and quality procedures.
• Pay prescribed fees.
• Undergo FDA inspection to verify compliance with the Regulation.
• Upon approval, receive an establishment registration certificate valid for a specified period (renewal required). https://en.fda.moph.go.th/media.php?id=482374780499140608&name=20091119%20Ministerial%20Regulation%20on%20Medical%20Device%20Establishment%20Registration.pdf

5. Special Provisions

• Separate registration required for each physical location.
• Changes in premises, ownership, or key personnel must be notified and may require re-inspection or amendment.
• Exemptions or simplified requirements may apply to certain low-risk or small-scale operations as specified by the FDA. https://en.fda.moph.go.th/media.php?id=482374780499140608&name=20091119%20Ministerial%20Regulation%20on%20Medical%20Device%20Establishment%20Registration.pdf

6. Compliance and Enforcement

Registered establishments must maintain ongoing compliance with the Regulation’s standards. Non-compliance may result in:

• Suspension or revocation of registration
• Prohibition of operations
• Penalties under the Medical Devices Act, including fines or imprisonment https://en.fda.moph.go.th/media.php?id=482374780499140608&name=20091119%20Ministerial%20Regulation%20on%20Medical%20Device%20Establishment%20Registration.pdf

The Thai FDA conducts periodic inspections and post-registration surveillance.

7. Role in Regulatory Framework

This Regulation forms an essential pillar of Thailand’s medical device regulatory system by ensuring that only properly equipped and managed establishments handle devices, thereby supporting overall product safety and quality throughout the supply chain. https://en.fda.moph.go.th/media.php?id=482374780499140608&name=20091119%20Ministerial%20Regulation%20on%20Medical%20Device%20Establishment%20Registration.pdf