Thailand Class 1 Medical Device Listing: Thai FDA Certificate of Listed Medical Device Guide

Quick answer

How do you register a Class 1 (Class A) medical device in Thailand?

To place a Class 1 (low-risk) medical device on the Thai market, a manufacturer or importer must first obtain an establishment license from the Thai Food and Drug Administration (Thai FDA), Medical Device Control Division. The registrant then determines risk classification under the ASEAN Medical Device Directive (AMDD) framework and grouping rules before submitting a Class 1 dossier. Upon review, Thai FDA issues a Certificate of Listed Medical Device—the regulatory route for Class 1 devices, distinct from the Certificate of Notified Medical Device (Classes 2–3) and Certificate of Licensed Medical Device (Class 4). Market placement is permitted only after the certificate is issued. The legal basis includes the Medical Devices Act B.E. 2551 and Ministerial Notification B.E. 2563 (2020), which defines Class 1 notification categories for devices posing low individual and public health risk. Class 1 listing requires a streamlined dossier (label, IFU, specifications, declaration of conformity, and related documents) rather than the full Common Submission Dossier Template used for higher-risk classes.

Who this applies to

This guide applies to:

• Thai and foreign manufacturers seeking to manufacture Class 1 medical devices in Thailand for commercial sale
• Importers placing Class 1 non-IVD medical devices on the Thai market
• Regulatory affairs teams mapping ASEAN AMDD Class A / Class 1 products to Thailand's listed-device route
• Local authorized representatives preparing establishment registration and listing applications on behalf of overseas manufacturers
• Quality and compliance staff assembling Class 1 submission dossiers before Thai FDA review

Thailand regulates medical devices in four risk classes aligned with ASEAN AMDD. Class 1 covers the lowest individual and public health risk. Some Class 1 product categories are defined in the 2020 Ministerial Notification B.E. 2563. Devices reclassified to Class 2, 3, or 4 follow notified or licensed routes instead—this article focuses on the listed (Class 1) pathway only.

Listed vs notified vs licensed: certificate types by risk class

Thai FDA assigns a certificate type based on AMDD risk class. The route determines dossier depth, review intensity, fees, and post-market obligations.

Key distinctions for regulatory planners:

• Class 1 (listed): Streamlined dossier; document verification fee applies; no expert review fee in the published fee schedule
• Classes 2–3 (notified): Full, abridged, or HSA reliance pathways; expert review fee applies
• Class 4 (licensed): Highest scrutiny; full dossier with expert review; highest certificate fees

Thai FDA states explicitly that once you receive the certificate of listed, notified, or licensed medical device, you may place the device on the market.

Legal framework

Thailand's medical device market access rests on:

Risk classification follows Annex 2 (general medical devices) and Annex 3 (IVDs) of ASEAN AMDD. Thai FDA publishes classification guidance and a self-check tool on its English portal. A preliminary online classification tool provides orientation only—it cannot substitute for official classification confirmation used in registration.

Step 1: Establishment registration (establishment license)

Before any device permission, anyone who wishes to manufacture or import medical devices for commercial purposes must register their establishment with Thai FDA.

Establishment registration is a mandatory prerequisite for Class 1 listing. Importers and manufacturers cannot submit a device listing application until the establishment license is active. Facility requirements for import operations—including storage, quality systems, and traceability—are covered separately under Thai FDA import-facility rules.

Foreign manufacturers typically route applications through a Thai establishment (local subsidiary or authorized importer) holding the relevant establishment license and a Letter of Authorization from the overseas manufacturer.

Step 2: Risk classification under ASEAN AMDD

After establishment licensing, the registrant must determine the device's risk classification. Thailand applies four classes consistent with ASEAN AMDD:

Classification depends on intended purpose, duration of use, invasiveness, and other AMDD rules in Annex 2 (general devices) and Annex 3 (IVDs). Thai FDA provides an interactive classification checker on its English portal.

Important: If a device is misclassified as Class 1 when it belongs in Class 2 or higher, Thai FDA may reject the listing or require re-submission under the notified or licensed route. Confirm classification before dossier assembly. Registrants may also apply for an official risk classification and grouping certificate from Thai FDA when formal confirmation is needed.

Certain product categories listed in Thai FDA announcements—such as contact lenses, surgical gloves, and specific IVD kits—may require full Common Submission Dossier Template (CSDT) pathways even when they appear low-risk. Check the Thai FDA Class 1 page and current ministerial announcements before assuming a streamlined listing dossier applies.

Step 3: Grouping determination

Grouping affects how many devices are covered in one application and which supporting documents are required. Thai FDA grouping criteria are published under the Notification of the Food and Drug Administration on Criteria for Grouping Medical Devices.

Before filing, determine whether your product is:

• A single medical device application, or
• A grouped medical device application covering multiple variants, models, or sizes under one listing

Grouped applications require a List of Medical Devices and Grouping in the submission dossier. Grouping rules interact with classification: the same manufacturer, intended use, and risk class typically must align for devices grouped under one certificate. Review grouping before finalizing the device list and label set.

Step 4: Class 1 submission dossier

Thai FDA publishes a defined Submission Dossier for Class 1 Medical Devices on its commercial manufacture/import page. Required documents include:

Unlike Classes 2–4, Class 1 does not require executive summary, essential principles checklist, risk analysis report, QMS certificate, or full CSDT—unless the product falls under a specific ministerial announcement requiring the full pathway.

Ensure labels and IFU reflect the exact models and trade names in the grouping list. Inconsistencies between the label, IFU, and grouping table are a common cause of verification delays.

Step 5: Application, fees, and certificate issuance

Class 1 listing fees under the Thai FDA MDA pilot project fee schedule:

For comparison, notified (Class 2–3) and licensed (Class 4) certificates carry expert review fees (30,400–53,000 THB depending on class and route) and higher certificate fees—reflecting the deeper dossier review for moderate- and high-risk devices.

After Thai FDA completes document verification, the registrant receives the Certificate of Listed Medical Device. Only then may the device be commercially manufactured, imported, and sold in Thailand.

Step-by-step workflow

1. Confirm product scope — Verify the article is a medical device under the Medical Devices Act and not excluded or regulated under another Thai FDA product category.
2. Register establishment — Apply for manufacturer or importer establishment license; pay fees; pass inspection; obtain establishment certificate.
3. Determine risk classification — Apply AMDD Annex 2/3 rules; use Thai FDA classification tools; obtain formal classification certificate if needed.
4. Determine grouping — Decide single vs grouped application; prepare List of Medical Devices and Grouping if applicable.
5. Assemble Class 1 dossier — Collect label, IFU, specifications, materials, declaration of conformity, conditional sterilization/calibration reports, authorization letter, and approval history.
6. Submit listing application — File through Thai FDA medical device registration channels with applicable fees.
7. Respond to verification queries — Address any Thai FDA document verification findings promptly.
8. Receive Certificate of Listed Medical Device — Confirm certificate details match approved models and trade names.
9. Place device on market — Begin commercial manufacture or import only after certificate issuance.
10. Maintain post-market obligations — Comply with QMS requirements for manufacturers/importers and advertisement approval rules before promotional activities.

Checklist

• Establishment license (manufacturer or importer) active before device application
• Risk classification confirmed as Class 1 under AMDD; no specific-announcement full-CSDT override
• Grouping strategy defined (single device vs grouped application)
• Label and IFU prepared for Thai market
• Product specification, device description, and materials documented
• Declaration of conformity signed by responsible party
• Sterilization report included (if sterilized device)
• Calibration report included (if measuring function)
• List of Medical Devices and Grouping prepared (if grouped application)
• Letter of Authorization executed (foreign manufacturer → Thai establishment)
• Regulatory approval history attached (if available)
• Listing fees budgeted (1,800 THB local manufacture / 3,100 THB import)
• Post-market QMS obligations understood for manufacturer or importer role
• Advertisement approval planned before any promotional activity

Common pitfalls

1. Skipping establishment registration — Device listing applications are not accepted without an active establishment license.
2. Misclassifying as Class 1 — Devices with higher AMDD risk must use notified or licensed routes; misclassification triggers rejection or re-filing.
3. Ignoring grouping rules — Multiple models submitted without a proper grouping list or with inconsistent intended-use claims delay verification.
4. Missing conditional reports — Sterilized devices without sterilization reports, or measuring devices without calibration reports, fail document verification.
5. Label–IFU–grouping mismatch — Trade names, model numbers, or configurations that differ across dossier documents cause verification loops.
6. Assuming foreign approval substitutes listing — CE marking, FDA clearance, or other reference approvals support the dossier but do not replace the Thai Certificate of Listed Medical Device.
7. Marketing before certificate issuance — Thai FDA states market placement is permitted only after the listed, notified, or licensed certificate is issued.
8. Overlooking specific-category announcements — Certain Class 1–appearing products (e.g., contact lenses, surgical gloves) may require full CSDT under ministerial rules.

FAQ

What is a listed medical device in Thailand?

A listed medical device is a Class 1 product that has received a Certificate of Listed Medical Device from Thai FDA after the registrant completes establishment registration, AMDD risk classification, grouping determination, and Class 1 dossier verification. Listed devices pose low individual and public health risk and follow the notification (จดแจ้ง) route under Ministerial Regulation B.E. 2563.

What is the difference between listed, notified, and licensed devices in Thailand?

Listed (Class 1) devices receive a Certificate of Listed Medical Device through a streamlined dossier and document verification. Notified (Classes 2–3) devices receive a Certificate of Notified Medical Device after detailed notification review, often with expert evaluation and fuller technical documentation. Licensed (Class 4) devices receive a Certificate of Licensed Medical Device after the highest level of scrutiny. All three certificate types authorize market placement once issued.

Do I need establishment registration before Class 1 device listing?

Yes. Thai FDA requires anyone manufacturing or importing medical devices for commercial purposes to register their establishment and obtain a manufacturer or importer establishment license before applying for device listing, notification, or licensing. Establishment registration is Step 3 in Thai FDA's published commercial pathway.

How does ASEAN AMDD classification work in Thailand?

Thailand aligns its four-class risk framework with ASEAN AMDD, using Annex 2 for general medical devices and Annex 3 for IVDs. Registrants determine class based on intended purpose, invasiveness, duration of contact, and other AMDD rules. Classification determines whether the device follows the listed (Class 1), notified (Classes 2–3), or licensed (Class 4) route and which dossier documents apply.

What documents are in the Class 1 submission dossier?

Thai FDA's Class 1 dossier includes: medical device label, IFU, product specification, device description and features, materials, declaration of conformity, regulatory approval history (if any), sterilization report (for sterilized devices), calibration report (for measuring devices), list of medical devices and grouping (for grouped applications), and letter of authorization. This is narrower than the full, abridged, or HSA reliance dossiers required for Classes 2–4.

Can I sell a Class 1 device in Thailand before receiving the listing certificate?

No. Thai FDA states that once you have received the certificate of listed, notified, or licensed medical device, you can place your medical device on the market. Commercial manufacture, import, or sale before certificate issuance violates the medical device permission framework under the Medical Devices Act and related ministerial regulations.

Official sources

• Thai FDA — How to apply for permission on medical devices
• Thai FDA — Manufacture or import medical devices for commercial purposes
• Thai FDA Medical Device Control Division — Class 1 medical device registration (md1)
• Ministry of Public Health — Ministerial Notification B.E. 2563 (2020) on Class 1 notification categories
• ASEAN — ASEAN Medical Device Directive (AMDD)