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Importing small medical supplies into Thailand: what approval applies
Importing small medical supplies: risk, not size, decides the approval
Anyone planning to import medical supplies into Thailand in small formats, such as self-test kits, specimen containers or wound dressings, may assume that cheap, simple products need no approval. The Medical Device Act B.E. 2551 (2008), as amended in 2019, does not grade control by size or price. Its definition covers instruments, reagents and materials intended to diagnose, prevent, monitor or relieve disease or injury, including examining specimens from the body, provided the main effect in the body is not achieved by pharmacological, immunological or metabolic means.
The amended Act splits control of manufacture and import into three groups by risk: listing (notification), detailed notification, and licence. An importer must hold a listing receipt, a detailed notification receipt or a licence before importing, and no one may sell a medical device that lacks one of these.
This guide focuses on two groups of small items people ask about most, test kits and wound dressings: which class they fall into, what to file, and which exemption routes exist. For the full picture of importing any medical device, see import medical devices into Thailand.
How test kits (IVD) are classified
The Ministry of Public Health notification on classifying medical devices by risk (2019) separates in vitro diagnostic (IVD) devices from other devices and grades IVDs into classes 1 to 4 by risk to individuals and public health. Class 1 is listed, classes 2 and 3 use detailed notification, and class 4 needs a licence. The rules most relevant to small test kits are:
- Self-test kits. Rule 4 places them in class 3, but kits whose results do not indicate a critical medical condition, or give a preliminary result that needs laboratory follow-up, fall into class 2. The notification gives pregnancy tests, fertility tests and urine tests as class 2 examples, and self-monitoring blood glucose kits as class 3.
- Kits for sexually transmitted infections, and tests where a wrong result could cause serious harm. Rule 3 places them in class 3.
- Kits that screen blood or tissue for infectious agents to assess transfusion or transplant suitability. These are in the notification listing devices that need a licence.
- Specific reagents, instruments used in the testing step, and specimen receptacles. Rule 5 places them in class 1, and the 2020 notification on devices requiring listing names this group.
If a product fits more than one class, the highest applies, and a product with several purposes is classed by its riskiest purpose. What decides the class is the intended use stated in the manufacturer's instructions, not the shape of the kit. If you are unsure whether a product is a device at all, try the product classifier.
Test kits with specific notifications, and research-use-only kits
Beyond the general risk rules, some test kits have specific notifications that add conditions on sale and labelling. Check them before ordering.
HIV test kits
The Ministry of Public Health notification on HIV-related test kits requires diagnostic kits to be licensed for manufacture, import and sale, and limits sale to health facilities, laboratories or bodies the Thai FDA accepts. The label must be in Thai and carry a clearly visible red statement that the general public must not use the kit for self-testing. HIV self-screening kits have a separate 2019 notification that sets kit standards and requires labels explaining limitations, how to read results and where to get confirmatory testing, because a self-test result is a screening result, not a confirmed diagnosis.
The 2020 notification on devices that may be sold only to health facilities or professionals also lists HIV test kits (except self-screening kits), so importers need to plan sales channels to match from the start.
Research use only (RUO) kits
A Thai FDA explainer separates products intended to give information from specimens for medical or diagnostic purposes from research products not used clinically. Research products must carry a statement on the label or instructions such as "for research use only, not for clinical or diagnostic use", and the RUO claim must match the product's real purpose. A kit sold to clinics for use on patients cannot carry an RUO label to avoid filing by risk class.
Wound dressings: class 1 to 4 depending on what the product does
Most wound dressings are non-invasive devices. Rule 1 of the 2019 risk classification notification sets the class by what the product does to the wound:
- Class 1: products that contact injured skin and are intended only as a mechanical barrier, for compression or to absorb exudate. Clause 2 (1) of the 2020 notification on devices requiring listing names this group, so they are listed.
- Class 2: products intended for wounds that breach the dermis, including products intended to manage the wound's microenvironment. These use detailed notification.
- Class 3: products intended for wounds that breach the dermis and can heal only by secondary intent. These also use detailed notification.
When a dressing moves into the licence group
The 2020 notification on devices requiring a licence covers devices that incorporate a drug, as defined by drug law, to assist the device's action, and devices made from or containing cells, tissues or derivatives of animal or microbial origin (except non-viable animal tissue that contacts only intact skin). Check dressings that contain a medicinal ingredient or biological material against this notification first.
The wording on the original pack matters too, because classification follows the intended purpose stated by the product owner. Two identical-looking dressings with different stated purposes can fall into different classes, so get the manufacturer's full instructions for use (IFU) before you order.
Source: MOPH notification on classifying medical devices by risk, 2019, and the 2020 listing and licence group notifications
Import license for medical devices in Thailand: register the establishment first
Whatever the class, the importer must first register an import establishment. People searching for an import license for medical devices in Thailand often expect a single permit, but the system has two layers: the establishment registration, then a filing for each product. The ministerial regulation on listing medical devices for manufacture or import (2020) makes listing available to registered establishments, so even class 1, the lightest route, cannot skip this step.
- File form Sor.Nor.1 following the Medical Device Control Division's manual for import establishment registration. The registrant's documents must include medical-device business objectives and an address matching the import premises.
- A foreign operator needs a passport and a work permit naming the registered company as employer.
- At least one import controller is required, with at least a bachelor's degree and residence in Thailand, under the 2024 notification on controllers. A qualified operator may act as controller.
- Prepare a map, layout and photos of the import and storage premises, with separate sets if they are at different sites.
For test kits that need temperature control, plan storage at this stage, because the storage site must have quality-preserving equipment suited to each product. Signage and off-site storage rules are covered in import medical devices into Thailand.
Documents to get from the product owner, by risk class
Once the establishment is registered, each product is filed by class. The core document lists come from three 2020 ministerial regulations.
- Class 1, listing: the registration number, product description and label, manufacturing or product owner information, foreign registration history if any, sterility test results or testing and calibration as applicable, a declaration of conformity, and a letter of authorisation from the product owner.
- Classes 2 and 3, detailed notification: product information, label and instructions, essential principles of safety and performance, design verification and validation, risk analysis, quality system evidence and the letter of authorisation.
- Class 4, licence: the class 2–3 set plus sales history and evidence of approval in other countries.
Several test kits in one application
The Thai FDA notification on grouping medical devices allows six grouping types. One is the IVD TEST KIT, which combines reagents and materials used together in one application, excluding any analyser used with them. A SET is two or more devices packed together for one purpose, such as a wound care kit, and takes the highest risk class of its contents. Selling the items separately requires single filings under the stated conditions.
Product names must match across every document: label, instructions, declaration of conformity and letter of authorisation. Screen manufacturer documents with the import document check, and see CFS vs EC certificate for foreign certificates.
Thai labels and conditions for reselling
The Ministry of Public Health notification on labels and instructions for medical devices (2025) requires devices used by the general public to have labels and instructions in Thai. Devices used by professionals may use Thai or English. Self-test kits and dressings sold in ordinary shops therefore need Thai labels and Thai instructions.
- The label must show product information, purpose, quantity, place of manufacture, permit number, lot and dates as applicable, clearly and without false or exaggerated statements.
- Imported devices must carry minimum information for inspection at the checkpoint, and the label and instructions must be corrected before sale, within 120 days of release.
- Instructions may be on paper or electronic.
Who may resell
The Act lets the Minister designate groups of devices whose sellers need a licence, so not every device needs a seller's licence. Check whether a product has a specific notification, such as HIV test kits, which need a sale licence, and the list of devices that may be sold only to health facilities or professionals. Shops buying from an importer to resell should confirm that each product has a listing receipt, detailed notification receipt or licence, because the law prohibits anyone from selling devices without one.
Small quantities, samples and personal use: exemption routes cannot be sold
Small items often arrive a few boxes at a time, to test the market or for personal use. Section 27 of the Act provides exemption routes for some purposes, each with its own conditions.
- Personal use. A 2025 Thai FDA notification sets out devices imported in quantities necessary for personal use, with separate lists for goods carried on arrival and goods ordered in, each with its own types, quantities and conditions. For example, no more than 2 hearing aids, and each type of device may use only one exemption route.
- Other specific cases. The notification on imports exempted under section 27 (8) covers cases such as repair and re-export, return after repair or exhibition abroad, donation and emergencies. An application must be approved before import, and it is not a general exemption for imported goods.
These routes serve only their stated purposes. Goods brought in for personal use cannot be sold. If you want to test the market, even with a small lot, register the establishment and file the product by class first.
Import checkpoints
The Ministry of Public Health notification designating medical device checkpoints (2025) lists airports, seaports, border points and post offices. If you ship by parcel, check the checkpoint name against the annex before choosing a route.
Using a registered Thai importer instead of importing yourself
People looking for a company to import medical devices for them are usually foreign product owners, or traders without their own establishment. One option is to import through a Thai importer that already holds an establishment registration. Understand how the documents are structured before you agree terms.
- The listing receipt, detailed notification receipt or licence is issued to the registered establishment that files it, and every import filing needs a letter of authorisation from the product owner.
- Owners should agree with the importer at the outset who holds the documents, who keeps the technical file, and what happens if the importer changes later.
- The importer carries continuing duties, such as following the quality system, reporting malfunctions and adverse events, keeping a complaints channel, and filing an annual import report by 31 March of the following year, as the Medical Device Control Division's legal handbook describes.
A listing receipt is valid for 5 years from the date shown on it, while establishment registrations, licences and detailed notification receipts run to 31 December of the fifth year. Importers holding several test kits should keep one table of products, classes, certificate numbers and expiry dates. If you want our team to help from establishment registration to product filing, see import services.
Checklist before your first order of test kits or wound dressings
Use this list before your first order of test kits, specimen containers or wound dressings.
- Confirm the product is a medical device, not a drug or cosmetic.
- Read the intended use in the manufacturer's instructions and assign a risk class from 1 to 4.
- Check specific notifications, such as HIV test kits and the list of devices sold only to health facilities.
- Check whether a dressing contains a medicinal ingredient or animal-derived material.
- Register the import establishment, with a controller and storage suited to the product.
- Get the letter of authorisation and class-specific documents from the owner, with matching product names.
- Prepare Thai labels and instructions for products the public will use.
- Hold the listing receipt, detailed notification receipt or licence before the goods arrive.
Start with the product classifier, then the import readiness check, and screen the manufacturer's documents with the import document check. Costs and timing for our services are set out in the quotation.
- ✓It is a medical device, not a drug or cosmetic
- ✓Risk class assigned from the intended use
- ✓Specific test kit notifications checkedSuch as HIV kits and the facilities-only sales list
- ✓Import establishment registeredWith a controller and suitable storage
- ✓Letter of authorisation and class documents complete
- ✓Thai labels and instructions for products the public uses
Frequently asked questions
What approval does a pregnancy test kit need?
The 2019 risk classification notification gives pregnancy tests as an example of a class 2 self-test kit, which uses detailed notification. The importer must register an import establishment first.
Do ordinary wound dressings need a licence?
Not if they are intended only as a barrier, for compression or to absorb exudate. Those are class 1 and are listed. A dressing that incorporates a drug to assist its action falls into the licence group.
Do I need an establishment registration to import a few boxes to test the market?
Yes. The law does not grade duties by quantity. Exemption routes serve specific purposes, such as personal use under the Thai FDA list, and those goods cannot be sold.
Can a kit labelled RUO be sold to clinics?
RUO means a research product not for clinical or diagnostic use, and the RUO claim must match the real purpose. To sell a kit for testing patients, file it under its risk class.
Is an English-only label acceptable?
Only for devices used by professionals. Devices used by the general public, such as self-test kits, need labels and instructions in Thai.
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
- MOPH notification on classifying medical devices by risk, 2019 · Open source · Search our archive
- MOPH notification on medical devices that manufacturers or importers must list, 2020 · Open source · Search our archive
- MOPH notification on medical devices that manufacturers or importers must license, 2020 · 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 for manufacture or import, 2020 · Open source · Search our archive
- Ministerial regulation on licences to manufacture or import medical devices, 2020 · Open source · Search our archive
- Thai FDA notification on criteria for grouping medical devices · Open source · Search our archive
- MOPH notification on HIV-related test kits · Open source · Search our archive
- MOPH notification on HIV self-screening test kits, 2019 · Open source · Search our archive
- Thai FDA explainer on IVD products and research-use-only products · Open source · Search our archive
- MOPH notification on labels and instructions for medical devices, 2025 · Open source · Search our archive
- MOPH notification on medical devices sold only to health facilities or professionals, 2020 · Open source · Search our archive
- Thai FDA notification on devices imported in necessary quantities for personal use, 2025 · Open source · Search our archive
- MOPH notification on imports exempted under section 27 (8) · Open source · Search our archive
- MOPH notification designating medical device checkpoints, 2025 · Open source · Search our archive
- Medical Device Control Division manual on import establishment registration · Open source · Search our archive
- MOPH notification on medical device controllers, 2024 · Open source · Search our archive
- Medical Device Control Division handbook on medical device law and operator duties (2nd edition) · 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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