The Three Thai Certificates: Listed, Notified and Licensed Medical Devices

1. Key takeaways

Thailand has no single certificate called a registration certificate. Instead, there are three certificates, applied according to the risk class, and the official English names published by the Thai FDA are the authoritative reference. Confusion over these names is one of the most common defects in cross-border documentation, and it is entirely avoidable by anchoring every document to the official nomenclature below. The three certificates correspond to three control measures of increasing intensity, listing for the lowest class, notification for the two middle classes and licensing for the highest class, so the certificate name itself tells an informed reader how much regulatory scrutiny the product has passed.

• Why do names get mixed up? Because consultancies translate the Thai terms inconsistently. Common errors include rendering Class 1 Listing as notification, which collides with the Class 2/3 Notification measure; rendering Notified Medical Device as a filed or declared device, which collides with the Vietnamese declaration concept; and rendering Licensed Medical Device simply as a registration certificate, which breaks the link with the other two certificates.
• The correct practice is to use the Thai FDA official English certificate names, with any local-language rendering added only as a secondary annotation at first mention.
• Validity periods: registration and notification certificates are valid for 5 years counted from the year of approval; the establishment licence is valid for 5 years; the sales licence is valid for 1 year.
• Certificates are issued in two tiers, Local Manufacture and Import, and the import tier carries higher official fees; imported goods additionally require an LPI for each shipment.

2. Legal basis

The certificate mapping rests on the MoPH risk classification notification B.E. 2562 (2019), in particular Articles 2, 3 and 5, which assign each risk class to its control measure, and on the validity provisions of the Medical Device Act (No. 2) B.E. 2562 (2019). The differences in control intensity show up in the dossier depth and review intensity rather than in the certificate titles. For Class 1, the submission covers labels, instructions for use, product specifications, device description, materials, a declaration of conformity and the authorisation letter; sterile devices or devices with a measuring function additionally need sterilisation or calibration reports, and ISO 13485 is not required at this level. For Class 2 and Class 3, a complete CSDT dossier is required, containing an executive summary, device description, the Essential Principles of safety and performance, verification and validation summaries, risk analysis, ISO 13485, the declaration of conformity and the authorisation letter, and an expert review may be triggered. For Class 4, all of the above is required plus clinical evidence, and expert review is frequently triggered. Reading the three tiers together, the step change occurs between Class 1 and Class 2: the move from listing to notification brings the full CSDT structure, the quality system certificate and the possibility of expert review, while the step from Class 3 to Class 4 mainly adds the clinical evidence layer on top of an already heavy dossier.

3. Expert insights

The practical value of precise certificate naming shows up in communication rather than in filing. When a Chinese management team hears that a product has a Thai registration certificate, the word carries no information about risk class, dossier burden or review pathway, and plans get built on the wrong assumption. A practical estimate of the documentation burden differs enormously across the three certificates: a Class 1 listing is a comparatively light package without ISO 13485, while a Class 4 licence involves the full CSDT structure plus clinical evidence and expert review. Reporting both the class and the certificate type together removes this ambiguity at zero cost. It also matters for the import tier: because the import tier carries higher official fees than the local manufacture tier, and each import shipment needs an LPI, the cost of an import-based market entry must be quoted with the correct tier from the beginning. Teams that quote the local manufacture fee for an import filing discover the gap only at payment, which is an avoidable embarrassment in front of management.

4. Practical recommendations

• Adopt a dual-label convention, Class plus certificate type, in every internal and external document, for example Class 4 product licence, Certificate of Licensed Medical Device, so that translation drift cannot change the meaning. This single convention eliminates most follow-up questions when reports circulate between regulatory, commercial and executive audiences.
• Cite the certificate name exactly as published on the Thai FDA website in the English form, and add explanatory renderings only as annotations at first mention.
• Checklist planning should follow the tier: build the Class 1 package without ISO 13485, the Class 2/3 package as a complete CSDT dossier, and the Class 4 package with clinical evidence added.
• Track validity dates on a single calendar: 5 years for notification and registration certificates from the approval year, 5 years for the establishment licence, and 1 year for the sales licence.
• When costing a project, state whether the Local Manufacture or Import tier applies, since import fees are higher and each shipment needs an LPI.

5. Verification checklist

• □ Thai FDA website For Commercial Purpose Step 5, certificate and fee tables covering the Certificate of Listed, Notified and Licensed Medical Device, in both Local Manufacture and Import tiers (pending verification).
• □ MoPH risk classification notification B.E. 2562 (2019), Articles 2, 3 and 5 confirmed (pending verification).
• □ Thai FDA website document checklists for Class 1 and for Class 2 to 4 confirmed (pending verification).
• □ Medical Device Act (No. 2) B.E. 2562 (2019) validity provisions confirmed (pending verification).

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