Quality System Evidence Requirements for Thailand Medical Device Registration

1. Key takeaways

Thailand requires a valid quality system certificate for Class 2-4 medical devices, and the country accepts three equivalent forms of evidence: an ISO 13485 certificate, a Thai GMP certificate, or a certificate issued against the Thai conformance assessment standard TCAS 13485. Under the Thai GMP notification B.E. 2566 (2023) and the Good Import and Sale Practice notification B.E. 2566 (2023), manufacturers of medium- and high-risk devices must comply with the updated GMP requirements, and holding one of these three certificates is the recognised way to comply. In practice, submitting an ISO 13485 quality system certificate is sufficient to satisfy the requirement, which makes the certificate one of the longest-lead inputs to the dossier and one of the cheapest problems to prevent early. Class 1 manufacturers are exempt from certification, but they are not exempt from the quality system itself, which is why low risk does not mean low requirements.

• Three accepted certificates: ISO 13485, Thai GMP, and TCAS 13485; any one of the three satisfies the Class 2-4 requirement.
• Class 1 is exempt from the certification action but must still upgrade facilities and build a quality system that meets the new GMP standard.
• The certificate scope must cover the legal manufacturer and the actual production site; a certificate covering only the head office while production happens under another legal entity cannot be fixed by a deficiency response and requires re-certification, a cycle measured in months.
• The certification body must be a body with credibility and sit within the IAF recognition framework; certificates that are not IAF-accredited are not accepted, the same interpretation applied in Vietnam and Malaysia.
• The licensed importer must also maintain GDPMD, the Good Distribution Practice for Medical Devices, or an equivalent quality management system, and accept Thai FDA inspection; this is a company-side requirement running in parallel with the manufacturer-side ISO 13485.

2. Legal basis

The obligations rest on two ministerial notifications: the GMP notification B.E. 2566 (2023) issued by the Ministry of Public Health, and the Good Import and Sale Practice notification B.E. 2566 (2023). Together they require manufacturers of medium- and high-risk devices to meet the updated GMP requirements, and they establish the accepted compliance routes. The Thai FDA website Class 2-4 document list names the Quality Management System Certificate as a mandatory item, and the Thai FDA GMP guidance confirms that Class 1 manufacturers are exempt from certification but must still comply with GMP. The Thai conformance assessment standard TCAS 13485 provides the domestic alternative to the international ISO 13485 certificate. The requirement on the licensed importer to maintain GDPMD or an equivalent system and to undergo Thai FDA inspection is described in article 45 of this guide series. For the accreditation status of certification bodies, the IAF recognition framework is the reference, and the current accreditation directory should be used as the authoritative list.

3. Expert insights

Reviewers do not ask whether a company owns an ISO 13485 certificate; they ask whether the certificate covers the legal manufacturer named in the dossier and the site where the product is actually made. Three failures account for most problems. First, the certificate lists only a broad category, such as medical devices in general, without covering the specific product family being declared. Second, the site named on the certificate differs from the actual production site; this is the most insidious case, because a group certificate may cover the parent company while actual production sits with a subsidiary or a contract manufacturer under a separate legal entity. Third, the certificate has expired or is suspended. The second case deserves particular emphasis: it cannot be resolved through a deficiency response during review, because the scope of a management system certificate is fixed by the certification body, so the only remedy is re-certification, and that cycle is measured in months, not days. A project that discovers this late loses far more time than any review delay. Checking the certificate scope, the site coverage, and the accreditation status of the issuing body in the first week of the project costs a fraction of a day each and prevents rework measured in months. The same discipline applies to the importer side of the project: GDPMD maintenance is an ongoing obligation, not a one-time document, and inspection readiness should be treated as part of the licence-holding duties rather than as an afterthought once the certificate has been granted.

4. Practical recommendations

• In the first week of the project, run a three-point check on the ISO 13485 certificate: confirm the certification body sits within the IAF recognition framework, confirm the certificate scope covers the product family being declared, and confirm the site named on the certificate matches the actual production site.
• If the certificate covers only the head office while production sits under another legal entity, start re-certification immediately rather than hoping the gap can be closed during review.
• Verify that the certificate has not expired and is not suspended, and diarise the recertification date so it does not fall inside the registration window.
• Confirm the licensed importer side of the project maintains GDPMD or an equivalent quality management system and is prepared for Thai FDA inspection.
• For Class 1 products, do not skip the quality system work: upgrade facilities and build the quality system to the new GMP standard even though no certificate is submitted.
• Where the existing certificate is Thai GMP or TCAS 13485, confirm it remains valid and equally acceptable before relying on it in the dossier.

5. Verification checklist

• □ Verification basis date: 26 October 2026.
• □ Thai FDA website Class 2-4 document list, naming the Quality Management System Certificate as a mandatory item.
• □ MoPH GMP notification B.E. 2566 (2023) and Good Import and Sale Practice notification B.E. 2566 (2023).
• □ TCAS 13485, the Thai conformance assessment standard.
• □ Thai FDA GMP guidance, confirming Class 1 is exempt from certification but must comply.
• □ Thai FDA requirement on licensed importers to maintain GDPMD.
• □ IAF recognition framework query, using the current accreditation directory as the authoritative reference.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Thailand. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the Thai FDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com