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Importers
Importing medical devices into Thailand: licensing by risk class, from listing to licence
Importing medical devices into Thailand: the legal picture
To import medical devices into Thailand you work under the Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019). The amendment aligned Thai law with the ASEAN Medical Device Directive and split control of manufacture and import by risk into three groups: devices that need a licence, devices that need a detailed notification, and devices that need a listing (a simpler notification added in 2019).
An importer always passes two layers. First, it registers an import establishment. Second, it files each product according to its risk group, and must hold a licence, a detailed-notification certificate or a listing certificate before importing. The 2019 amendment also prohibits anyone from selling a device that lacks one of these, so shops and downstream distributors should check a product's status before taking it on.
Is your product really a medical device?
The definition in the 2019 amendment covers instruments, appliances, implants, reagents, software and accessories intended for diagnosis, prevention, monitoring or alleviation of disease or injury; examining, replacing or supporting anatomy or physiology; supporting life; contraception or assisted reproduction; aiding people with disabilities; examining specimens from the body; or disinfecting medical devices. The key condition is that the main intended action in the body is not achieved by pharmacological, immunological or metabolic means. If it is, the product falls under drug law instead.
Two groups are often borderline:
- Beauty products used with needles or machines. The Thai FDA cosmetic notification criteria state that products used with needles or devices to push substances through the skin are not cosmetics.
- Software and apps. The Thai FDA guidance on software and AI as medical devices (October 2024) starts with screening for a medical purpose; software with no medical purpose is not a medical device.
If you cannot yet say which law the product falls under, stop here first. Documents and responsible parties differ completely between laws.
Thai medical device risk classification: classes 1 to 4
The 2019 MOPH notification on classifying medical devices by risk splits devices into in vitro diagnostic (IVD) devices and non-IVD devices, each with four classes.
| Class | Risk (non-IVD) | Control | Certificate |
|---|---|---|---|
| 1 | Low | Listing | Listing certificate |
| 2 | Low to moderate | Detailed notification | Detailed-notification certificate |
| 3 | Moderate to high | Detailed notification | Detailed-notification certificate |
| 4 | High | Licence | Licence |
Non-IVD rules look at invasiveness, duration in the body, mode of use and biological effect. The Medical Device Control Division's classification guide defines duration as transient (under 60 minutes), short term (60 minutes to 30 days) and long term (over 30 days). IVD rules look at intended purpose, indications, user expertise and the impact of the result on the individual and on public health.
If a device fits more than one class, the highest applies. Devices used together are assessed one by one, and a device with several purposes takes the riskiest purpose. Separate notifications list the groups that require listing and those that require a licence, with specific features and exceptions, so always read them together. Classification disputes are decided by the Thai FDA Secretary-General.
Source: MOPH notification on classifying medical devices by risk (2019) and the 2020 ministerial regulations
Medical device establishment registration in Thailand comes first
Before filing any product, the importer registers its import establishment on form Sor.Nor.1 through e-Submission. The Medical Device Control Division's licensing manual and document checklist set the main conditions:
- The registrant may be an individual or a juristic person; a company's objectives must cover medical devices and its address must match the import premises.
- A foreign operator needs a passport and a work permit naming the registered company as employer.
- An original medical certificate for the operator is required, and applicants must not have the diseases listed by MOPH: leprosy or tuberculosis in a communicable stage, serious narcotic addiction and chronic alcoholism.
- At least one import controller is required, with at least a bachelor's degree and residence in Thailand, under the 2024 MOPH notification; a qualified operator may act as controller.
Import and storage premises
- Storage must be clean, with enough light and ventilation, quality-preserving equipment suited to each device type and sufficient for the volume, and devices stored by category.
- Submit a map, scaled floor plan and photos; separate sets are needed if the import and storage premises are at different addresses.
- Someone else's storage may be used with a letter of consent to use the storage premises.
- Permanent signs are required: import premises on a green background and storage premises on a red background, at least 20 × 70 cm, under the 2021 notification on premises signs.
- Temporary storage outside the licensed premises needs prior permission under the 2024 notification.
An establishment registration runs until the end of the fifth year, and holding one does not replace filing each product.
Documents for medical device import: what the product owner must supply
Combined from the 2020 ministerial regulations on listing, detailed notification and licensing, the dossier guidance and the Medical Device Control Division's templates:
| Document | What it must contain |
|---|---|
| Letter of Authorization | From the product owner, naming the products and models covered and the authority to file and certify documents; required for imports in every group |
| Certificate of Free Sale | From the country of manufacture or of the product owner, issued or certified by a government agency or a recognised private body, and still valid |
| Quality system certificate | ISO 13485 or GMP, naming the manufacturer, site and a scope matching the product |
| Declaration of Conformity | With foreign registration history, if any |
| CSDT dossier | For classes 2–4, as described in the next section |
| Class 1 documents | Product details, label, manufacturing information, and sterility or testing and calibration results as applicable |
| Labels and instructions for use (IFU) | The English name must match across label, IFU, product list, DoC and LoA, with the generic name and GMDN code |
| Translations | Non-English documents need a certified Thai or English translation |
Software as a medical device needs evidence of a development process under IEC 62304 or equivalent and cybersecurity management across its life cycle. For the EU, some documents say an EC Certificate or Declaration of Conformity can support the file under conditions; that rule comes from a 2007 regulation, so confirm with officers before relying on it. Our import document checker reads expiry dates, signatures and manufacturer names across documents. See also Letters of Authorization and Certificates of Free Sale.
The CSDT dossier and full versus concise evaluation
Classes 2–4 file in the ASEAN Common Submission Dossier Template (CSDT). The division's non-IVD dossier guidance orders the sections as follows:
- Product information and scope, manufacturer and product owner
- Executive summary and essential principles of safety and performance
- Device description
- Design verification and validation, such as performance, biocompatibility, sterilisation, stability and clinical data
- Labelling, risk analysis and manufacturing information
The same guidance requires every section to be completed, with a justification for any that does not apply. Application details must match the establishment registration, and certificates must remain valid; one that expires before the product certificate is issued must be replaced.
The Thai FDA notification on full and concise evaluation allows a concise route where there is approval evidence from a reference country or WHO under the criteria, and the intended purpose, indications, label, IFU and packaging match the approved version. A foreign registration alone does not satisfy every criterion. The division also runs a regulatory reliance programme with Singapore HSA, which has its own application letter.
Several models can be filed in one application under six grouping types: SINGLE, SYSTEM, FAMILY, SET, IVD TEST KIT and IVD CLUSTER. A SET of two or more devices, for example, takes the highest risk class of its items.
Thai labels and instructions for use
The 2025 MOPH notification on medical device labels and instructions sets out:
- Devices used by the general public need labels and instructions in Thai; devices for professionals may use Thai or English, and other languages must not conflict.
- Labels show product information, intended purpose, quantity, manufacturing source, licence number, model and dates as applicable, clearly and without false or exaggerated statements.
- Instructions may be on paper or electronic; software without a physical form shows electronic information in Thai or English.
- Imported devices need minimum information for checking at the border, and correct labels and instructions before sale, within 120 days of customs release.
Another rule affects sales plans: the 2024 MOPH notification bans direct selling and direct marketing of devices that must be used by or under the guidance of medical and public health professionals. If you plan to use that channel, check first whether the device is one the public can use on its own.
Thai FDA medical device import checkpoints and exemptions
The 2025 MOPH notification on medical device checkpoints (replacing the 2023 version) lists the airports, seaports, land borders and postal points for imports, such as Suvarnabhumi, Don Mueang, Bangkok Port, Lat Krabang and Laem Chabang. Check the checkpoint against the schedule before booking the shipping route.
The law has exemption routes for certain purposes, each with its own documents:
- Personal-use imports in necessary quantities, under the 2025 Thai FDA notification, which has lists for items carried in and items ordered in, for example no more than two hearing aids.
- Samples, exhibitions, education or research; research on humans needs a copy of ethics committee approval.
Devices imported under an exemption may not be sold. To sell, go back through establishment registration and product filing by risk class.
Importer duties after the certificate
- Use only the named premises, follow the quality system and keep a controller in place; a controller who leaves must be reported to the authority within 30 days.
- Report malfunctions and adverse events, whether they occur in Thailand or abroad, and run a complaint channel and handling system.
- Keep import and sales records at the registered premises for at least five years from import or sale; for devices with an expiry date, also at least one year after expiry.
- Submit the annual report by 31 May of the following year, under the 2025 notification on records and reports, which repealed the 2021 notification and makes electronic records the default.
- A listing certificate lasts five years and must be renewed before expiry; changes to listed information must be reported.
- Closing the business must be notified in writing within 30 days.
Importing without the certificate a device's group requires is punishable by imprisonment or a fine under the Act, with heavier penalties for higher-risk groups. An importer with many products should keep one register listing each product's class, certificate number and expiry date.
Checklist before you order medical devices
- The product is confirmed as a medical device, not a drug or cosmetic.
- Risk class 1–4 is set, checked against the listing and licence group notifications.
- The import establishment is registered (Sor.Nor.1), with a controller and premises signs.
- A Letter of Authorization names every product and model.
- CFS, ISO 13485 or GMP certificate and DoC are in hand and not expired.
- Product names match across all documents, with generic name and GMDN code.
- For classes 2–4, the CSDT covers every section or justifies any omitted.
- Thai labels and instructions are ready for devices used by the public.
- The listing certificate, detailed-notification certificate or licence is issued before ordering.
Start with our import readiness checker, then run the owner's documents through the import document checker. For help from establishment registration to product filing, see our import service; costs and timing are set out in the quotation.
- ✓Confirmed as a medical device, not a drug or cosmetic
- ✓Risk class setChecked against the listing and licence group notifications
- ✓Import establishment registered (Sor.Nor.1)With a controller and premises signs
- ✓LoA naming every product and model
- ✓CFS, quality system certificate and DoC still valid
- ✓Product names match across documentsWith generic name and GMDN code
- ✓Complete CSDT for classes 2–4
- ✓Thai labels for devices used by the public
Frequently asked questions
Does a class 1 device need a licence?
No licence, but it must be listed and hold a listing certificate before import. Classes 2–3 need a detailed notification and class 4 needs a licence.
Do I need establishment registration before filing products?
Yes. Register the import establishment on Sor.Nor.1 first, then file each product by risk class.
Which class applies if a device fits two?
The higher one, under the 2019 MOPH notification on classifying medical devices by risk.
Is an English-only label acceptable?
Only for devices used by professionals. Devices used by the general public need Thai labels and instructions.
What qualifications does an import controller need?
At least a bachelor's degree and residence in Thailand; each establishment needs at least one.
Sources
- Medical Device Act B.E. 2551 (2008) and amendments (Council of State version) · Open source · Search our archive
- Medical Device Act (No. 2) B.E. 2562 (2019), Royal Gazette · Open source · Search our archive
- Medical Device Act B.E. 2551, consolidated text with the 2019 amendment · Open source · Search our archive
- Thai FDA criteria for cosmetic notification (revised 2021) · Open source · Search our archive
- Thai FDA guidance on software and AI as medical devices (October 2024) · Open source · Search our archive
- MOPH notification on classifying medical devices by risk, 2019 · Open source · Search our archive
- Medical Device Control Division guide to risk classification · Open source · Search our archive
- MOPH notification on device groups requiring listing, 2020 · Open source · Search our archive
- MOPH notification on device groups requiring a licence, 2020 · Open source · Search our archive
- Medical Device Control Division manual for import establishment registration · Open source · Search our archive
- Document checklist for new import establishment registration (Sor.Nor.1) · Open source · Search our archive
- MOPH notification on prohibited diseases for establishment registrants, 2009 · Open source · Search our archive
- MOPH notification on medical device controllers, 2024 · Open source · Search our archive
- MOPH notification on medical device import premises, 2009 · Open source · Search our archive
- Template letter of consent to use medical device storage premises · Open source · Search our archive
- MOPH notification on medical device premises signs, 2021 · Open source · Search our archive
- MOPH notification on temporary storage outside licensed premises, 2024 · Open source · Search our archive
- Ministerial Regulation on listing medical devices for manufacture or import, 2020 · Open source · Search our archive
- Ministerial Regulation on detailed notification of medical devices, 2020 · Open source · Search our archive
- Ministerial Regulation on licences to manufacture or import medical devices, 2020 · Open source · Search our archive
- Letter of Authorization template (imports) · Open source · Search our archive
- Thai FDA regulation on certificates for importing medical devices and border exemptions, 2007 · Open source · Search our archive
- Medical Device Control Division guidance on non-IVD dossiers (CSDT) · Open source · Search our archive
- Full-CSDT checklist for general non-IVD devices, classes 2, 3 and 4 (Rev.2, 2024) · Open source · Search our archive
- Thai FDA notification on full and concise evaluation · Open source · Search our archive
- Application letter for the Thailand FDA and Singapore HSA regulatory reliance programme · Open source · Search our archive
- Thai FDA notification on grouping medical devices · Open source · Search our archive
- MOPH notification on medical device labels and instructions, 2025 · Open source · Search our archive
- MOPH notification banning direct selling of certain medical devices, 2024 · Open source · Search our archive
- MOPH notification on medical device checkpoints, 2025 · Open source · Search our archive
- Thai FDA notification on personal-use medical device imports, 2025 · Open source · Search our archive
- MOPH notification amending exemptions under section 27 (5)–(7), No. 3, 2023 (research) · Open source · Search our archive
- MOPH notification on records and reports for the manufacture, import or sale of medical devices, 2025 · Open source · Search our archive
This article is for general information. It is not a Thai FDA ruling or legal advice, and rules change — check the latest notification or ask an expert before filing or producing.
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