Thai FDA Medical Device Registration Thailand

1. A Thai importer registers its import establishment. A foreign manufacturer or product owner cannot file with Thai FDA directly; filings go through the Thai applicant's e-submission account.
2. Confirm the risk class. Thailand numbers its classes 1 to 4 rather than lettering them, and the lowest-risk tier is Class 1.
3. File the route that matches the class: listing for Class 1, detailed listing for Class 2 and 3, licence for Class 4.
4. Prepare the label and IFU to Thai rules. Since 20 June 2026, devices used at home need a Thai label and IFU.

Following the common ASEAN framework, Thailand divides medical devices by risk into Class 1 to 4, and the route and the volume of documents differ completely by class between listing, detailed listing and license. That is why classification is the starting point of every consultation.

Where a device fits more than one class, the highest applies, and a device with several intended uses is classed by its riskiest use (MOPH Notification on risk-based classification, 2019).

Often it is not even clear whether the product is a medical device. Cosmetic coloured lenses are medical devices, and devices meant only for animals go through the listing route. The FDA publishes classification determination tables by product group — sports equipment, maternity and childcare products, sterilisation, disinfection and cleaning products, software, COVID-19-related products and others — so these tables give a first determination, and what remains is confirmed officially through the medical device determination system. Software and AI have their own regulatory guidance, so whether a health app is a medical device (SaMD) is settled first.

In-vitro diagnostics use the same Class 1–4 scale and the same routes, under seven IVD rules in the 2019 classification notification. Examples from the rules:

• Class 4: screening blood or transplants for transmissible agents such as HIV, HCV, HBV and HTLV
• Class 3: tests for sexually transmitted and other serious infections, cancer and companion diagnostics, human genetic testing, viral load, and self-tests in general
• Class 2: non-critical self-tests such as pregnancy and fertility tests, and anything the other rules do not catch
• Class 1: procedure-specific reagents, IVD instruments and specimen receptacles

For Class 2–4, Thai FDA's Full-CSDT checklist asks every application to state whether the device is for home use or professional use, its class and its grouping. HIV test kits also have their own notifications and sales rules, and a Research Use Only (RUO) label on its own does not allow sale without registration.

A product can only be filed under a registered establishment. The Thai importer obtains import establishment registration (Sor.Nor.1); a domestic manufacturer obtains manufacturing establishment registration (Sor.Phor.1). The certificate names the operator (ผู้ดำเนินกิจการ) who carries legal responsibility for import or manufacture; for a company the board appoints this person. A foreign national serving as operator needs a work permit.

The facility requirements are specific: an interior floor plan with the scale stated that separates the import office from the storage room (one plan per floor where there are several), a qualified controller and establishment signage. For cold-chain products, temperature mapping, data-logger placement and calibration and temperature-excursion alarms are all inspection items. After registration the establishment is subject to proactive inspection and to import and sales quality-system (GDP) audits.

Do you need a licence to sell? Not for most devices. A sales licence is required only for groups Thai FDA has designated: hyaluronic-acid dermal fillers, silicone breast implants, blood bags, HIV test kits, ophthalmic viscoelastic products, tooth-whitening products, listed dental devices and positive airway pressure (PAP) devices, which can be sold to consumers only on prescription. Import and sales establishments still fall under the 2023 import and sales quality-system (GDP) notification.

The operator must live in Thailand (Medical Device Act, section 16). A brand without a Thai entity therefore works through a Thai importer, or through license holding.

Thailand uses the ASEAN Common Submission Dossier Template (CSDT). An existing ASEAN technical file is a starting point, but product identification, intended use, risk management, clinical or performance evidence and labeling must be checked again against the scope of the Thai application. When filing a detailed listing or license with a full CSDT, the FDA's published worked examples are the reference, and long submission PDFs must be bookmarked.

The Declaration of Conformity (DoC) is prepared by the product owner or the actual manufacturer, must be in English and uses Thai FDA's DoC form; the risk class on it must match the Thai class. The letter of authorisation also uses the Thai FDA form. The IFU sits inside the dossier: the regulations list the label and IFU among the filing documents, so they are reviewed together with the technical file.

Using an existing approval. Thai FDA recognises assessments by eight foreign bodies: US FDA, EU notified bodies, Australia's TGA, Health Canada, Japan's MHLW, WHO prequalification of IVDs, and, under their reliance programmes with Thai FDA, Singapore's HSA and Malaysia's MDA. The route is voluntary and covers Class 2–4 only. The product must not have been approved through an evaluation-exempt route, approvals from the first six bodies must be at least a year old, and the intended use, indications, labeling, IFU and packaging filed in Thailand must be the same as those approved abroad. It changes how the dossier is evaluated; it does not replace the Thai review.

A 2025 Ministry of Public Health notification on labels and IFU replaced the 2020 rules and took effect on 20 June 2026.

• Language: devices used at home, including devices prescribed for use outside a healthcare facility, need a label and IFU in clear Thai. Devices for professional use may use Thai or English.
• IFU contents: name, description, intended use, indications, instructions, contact details, storage, warnings and contraindications, and the IFU revision date or code. Paper or electronic formats such as a QR code or website are allowed.
• Imported devices: a Thai or English label with the minimum items is enough at the checkpoint; the full label and IFU must be in place before sale and no later than 120 days after release.
• Transition: labels made under the 2020 notification may be used for up to two years after the new notification took effect.

Advertising aimed at the general public requires a formal license (ฆพ.1). Advertising made directly to medical and public-health professionals is exempt from the license, but for online media a letter explaining how access has been restricted to professionals must be submitted. Where a Class 2 to 4 product is advertised with its registered intended-use wording as it stands, or with the same content as an existing license, a fast track shortens the review.

Expressions that cannot be used are collected in an example set. Words that exaggerate efficacy or quality — best, miracle, cure, instant effect, number one, guaranteed — are the typical cases, and there are media rules too: choosing video media means submitting a storyboard, and it cannot be selected together with print media.

• Annual performance reporting — Manufacturing, import, sales and manufacturing-for-export performance is reported through the system every year. Some product types, such as software for medical professionals, add quarterly reports.
• Adverse-event reporting — Domestic malfunctions and adverse events are reported according to the guidelines; overseas cases are reported in a half-yearly summary.
• Distribution records — Forms are kept in accordance with the notification on manufacturing, import and sales records and reporting.
• Quality system — Import and sales establishments prepare for inspection against the GDP audit manual, manufacturing establishments against the GMP manual.
• Changes — Amending establishment registration details (Sor.Nor.4), adding a controller and relocating each need their own form and floor plans (before and after).

Samples before registration come in under the exemption route of Section 27 of the Medical Device Act. Samples for registration review, commercial samples and samples for testing and analysis each use a different form, and commercial samples require evidence of disposal, return or donation after use.

• Confirming the class. Settle it with the classification determination tables and the determination system before building the documents.
• Establishment registration. It is a precondition for filing; product documents can be prepared alongside it.
• Who prepares the DoC. The product owner or actual manufacturer prepares it in English; Thai or the importer's name is not accepted.
• Thai IFU. Home-use devices need a Thai label and IFU, translated in full from the manufacturer's IFU.
• What an overseas approval does. At most, abridged evaluation is considered for classes that meet the conditions; it does not replace the Thai review.
• Who the advertising addresses. Consumer advertising requires a formal license.
• RUO labeling. Labeling method and permitted buyers have their own guidance, so it does not stand in for registration.

Your project is led by specialists with more than ten years managing global accounts in the Thai entities of global regulatory and testing firms.

We combine regulatory evidence retrieved through Doosigan RAG with specialist judgment. Comparing source guidelines with product documents helps establish the applicable requirements and reasoning for authority responses. Our specialists review intended use, the IFU and labels, model configuration and the CSDT technical file together. Your specialist manages the product-specific issues, testing coordination and filing work within the agreed scope.

Useful for an initial review: intended use, product description, IFU and current labels, list of models and components, existing CSDT, QMS certificates, overseas approval and marketing history

For this product category, we coordinate overseas manufacturer documents with the Thai applicant's existing licenses, product scope and distribution plan. We review new models, label changes and renewal or amendment needs before filing. The applicant and permit scope are assessed for each project.

Where needed, explore Thailand license holding or Importer of Record services alongside your product requirements.