Thailand Medical Device Registration:
An Interview with Our Thailand Partner DeeMED Consulting

Thailand regulates medical devices under its own four-class, risk-based system, and CE marking or US FDA clearance does notcarry over directly. In this interview, Jerrod Lottinger, Co-Founder and Managing Director of DeeMED Consulting, a Bangkok-based regulatory consulting firm working across every category of Thai FDA regulation, explains how manufacturers shouldapproach classification, the technical file, labelling, the local license holder and post-market duties.

1. What's the biggest misconception manufacturers have when they first look at Thailand?

That CE marking or US FDA clearance will carry over. They won't, not directly. Thailand regulates devices under its own four-class, risk-based system administered by the Medical Devices Control Division (MDCD), and CE or FDA clearance is supportingevidence in a Thai submission, not a substitute for it. The other misconception is that a distributor can act as the manufacturer'sThai license holder without consequence. The registration has to be held by an establishment-licensed Thai importer ormanufacturer, and if that entity is a commercial distributor and the relationship sours, they keep the registration. Moving it to anew holder requires their written consent under Thai FDA's document transfer procedure. We see manufacturers hand overcontrol of their own Thai market access this way more often than you'd expect.
 

2. Walk us through Thailand's classification system. How does it differ from FDA or EU MDR?

Thailand follows the ASEAN Medical Device Directive (AMDD), whose classification rules turn on invasiveness, duration of bodycontact, whether the device is active or non-active, and intended purpose. Thailand assigns numerical classes 1 to 4, aligned withthe AMDD's letters A to D, with Class 1 as the lowest risk and Class 4 as the highest. The important point is that these rules don'tmap cleanly to FDA risk categories or EU MDR classes. A device's FDA class does not reliably tell you its Thai class, which dependson intended use and invasiveness as actually labeled for the Thai market. Classifying by analogy to a home-market class is thesingle most common source of misclassification we see.

3. What happens if a company gets the classification wrong?

Defects found when the application is screened have to be corrected within the officer's deadline, otherwise the file is closed. Awrong class means the wrong dossier, the wrong fees and a restart under the correct class, so the mistake is usually caught early,but early doesn't mean cheap. It's the reason we tell manufacturers to treat classification as a determination made against defined AMDD criteria, not a judgment call based on how the device was classified somewhere else.

4. Is ISO 13485 enough on its own?

A current quality-system certificate, typically ISO 13485, is required in the dossier for Classes 2, 3 and 4. But it certifies themanufacturer's quality management system. It doesn't substitute for product-specific clinical evidence, risk managementdocumentation, or format compliance with the ASEAN Common Submission Dossier Template, which is Thailand's requireddossier structure. No quality-system certificate is filed for Class 1 listing devices.

5. Can manufacturers reuse their CE technical file for the Thai submission?

The underlying science, yes. The structure, no. The CSDT shares its scientific basis with a CE technical file but differs in requiredannexes, structure, and language obligations, and the application is checked for completeness at screening. A reformatted CE filesubmitted as a CSDT is a common failure mode. Most manufacturers adapting existing CE or FDA documentation need aThailand-specific gap analysis before filing, not just a repackaging exercise.

6. What does a typical Thai technical file contain, and what is specific to Thailand?

Thailand requires the ASEAN Common Submission Dossier Template (CSDT). Its table of contents is set out in Annex 4 of the ASEAN Medical Device Directive:

• Executive summary

• Relevant Essential Principles and the method used to demonstrate conformity

• Device description: features, intended purpose, indications, instructions for use, contraindications, warnings, precautions,potential adverse effects, alternative therapy, materials and other specifications

• Summary of design verification and validation: pre-clinical studies (including software verification and validation, andbiological material where relevant) and clinical evidence

• Labelling: samples of the labels and the instructions for use

• Risk analysis and its results, typically supported by an ISO 14971 risk management file

• Physical manufacturer information, including the manufacturing process

 

Our CSDT technical file guide walks through each section. The Thailand-specific parts are less about the science and more aboutthe local structure: a Thai license holder with an establishment license, a Letter of Authorization, and Thai-language labelling forhome-use devices. Depth rises with class: higher-risk devices need stronger clinical evidence, and a clinical investigation is mostlikely at the high-risk end. The sections that most often hold up a first submission, in our experience, are the clinical evidence andthe risk analysis, because they are the two parts that cannot simply be lifted from a CE file.

7. How does that compare with other ASEAN countries?
 

The common starting point is the ASEAN Medical Device Directive and the CSDT format, which Singapore, Malaysia and Thailandall use. But a shared format is not shared approval. The Directive contains no operative mutual recognition between memberstates, and each state keeps its own rules, including national-language labels. The differences show up in four places.

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1. Reliance:

Singapore offers abridged routes based on approvals from regulators such as the US FDA, EU notified bodies,Health Canada, TGA and Japan's MHLW. Malaysia recognises approvals from a similar group and lists Thai FDA Class 2 to 4 certificates among them, and Singapore also accepts Malaysian MDA approval. Since 1 May 2026, a Class B to D device with Malaysian MDA approval can skip Thailand's external expert evaluation if the CSDT dossier is complete.

 

2. Local presence:

Thailand needs an importer or manufacturer establishment license before the registration. Malaysiarequires an establishment license as a local manufacturer or authorised representative. In every case it is the local holder,not the overseas manufacturer, who carries the registration.
 

3. Language:
Thailand requires Thai labels for home-use devices but accepts Thai or English for professional-use devices.Malaysia requires Bahasa Malaysia for home-use devices. Singapore asks for documents in English.
 

4. Lowest-risk route:
all three have a lighter route for the lowest-risk class rather than full registration (Class 1 listing in Thailand, Class A product notification in Singapore, and Class A in Malaysia exempt from conformity assessment but stillsubmitted through MeDC@St). Other ASEAN states such as Vietnam and Indonesia have their own local-entity andlanguage rules, so check each one before planning.

8. What counts as a significant change, and how long does review take?
 

Once a device is approved, changes still have to go through Thai FDA, and since 15 January 2025 the route depends on the class.For Class 1 listed devices, changes are filed in Thai FDA's Skynet system and approved automatically. For Class 2, 3 and 4 devices,the change is submitted to Thai FDA with the fee, an officer reviews it, and it may go to an outside expert, which carries its ownexpert evaluation fee. Thai FDA sorts Class 2 to 4 changes into major and minor. Adding device items to the approval is a majorchange. Reducing items, or only changing the import or manufacturing site details shown on the label, is minor. The supportingdocuments depend on the change topic. For changes that affect the device itself they typically include the updated label and IFU,the declaration of conformity, a comparison table of the design, specification, intended use and indications, the device description,manufacturing information, a verification and validation summary and the ISO or GMP certificate, with risk analysis, clinicalevidence or proof of the original regulator's approval added where relevant. On timing, Thai FDA's 2022 change guideline setabout 35 working days for a major change, including the expert review, and 5 working days for a minor one. The process wasrevamped in January 2025 and no updated official time has been published since, so we plan each case individually and tell clientsto build in buffer.

9. Are there special labelling requirements in Thailand?

Yes, and they changed this year. The new labelling notification, B.E. 2568, was published in the Royal Gazette on 22 December 2025 and took effect on 20 June 2026. For home-use devices the label and instructions must be in Thai. For devices used by professionals, Thai or English is accepted. At a minimum the label has to carry the product name and intended purpose, thequantity, the manufacturer or importer name and address (an importer also shows the manufacturing site, city and country), theThai FDA approval number, the lot or serial number, and either the manufacture date or the expiry date or service life, asapplicable. Software and app devices in Class 2, 3 and 4 must also show a UDI where one exists. The timing rule catches peopleout: the labels must be complete before the device is sold, and in any case within 120 days from the day the inspection checkpoint releases the shipment for import. Labels that complied with the 2020 notification can stay in use until 20 June 2028. Our Thai medical device labelling requirements guide sets out the full list. The most common mistake we see is shipping product first and starting the Thai artwork afterwards.

10. What happens after approval? What are the post-market obligations?

Approval is the start of the license holder's obligations, not the end. The license holder, meaning the Thai importer or licensee, isthe party that must report, not just the manufacturer, and this covers events in Thailand and abroad. A serious public health threatmust be reported immediately and within 48 hours of becoming aware of it. A death or serious deterioration in health must bereported within 10 days, and a technical finding that a recurrence could cause one within 30 days. A follow-up report is due 30days after the initial one. Events that happen outside Thailand are reported twice a year, with January to June events due by theend of August and July to December events by the end of February. For field safety corrective actions, the initial report is duewithin 48 hours of learning that one will be carried out, and the follow-up within 21 days of the previous report. On top of that,there is a routine reporting duty. A new record-keeping and reporting notification, signed in December 2025 and in force since 1 March 2026, requires registered establishments to keep their manufacture, import and sale records electronically for at least fiveyears from the date of manufacture, import or sale, or at least one year past the expiry date if that is longer. Annual manufactureand import reports are due by 31 May of the following year, which is a change from the old 31 March date. Quarterly sales reports apply only to devices containing mercury or radioactive material and to a list of devices needed in an emergency, and softwaredevices for medical professionals file an annual sales report.

11. What else can you provide beyond registration? Do you handle distribution?
 

We act as Local Authorized Representative and Importer of Record, we prepare and file the dossier, we handle the establishmentlicensing for the Thai entity, and we manage change applications, renewals and post-market reporting once the device is on themarket. We do not distribute. That is deliberate. Because we have no commercial interest in the product, the manufacturer keeps aregulatory partner in the license holder seat instead of a party with an incentive to hold the registration. When a client needs adistributor, we can introduce vetted ones and stay on as the regulatory holder.
 

12. What should manufacturers budget for, in cost and time?
 

Cost has layers most manufacturers don't expect until they've been through it once. In government fees before any expert review,an imported device pays about 3,100 THB at Class 1, rising to about 21,000 THB at Class 4. On top of that, Thai FDA can refer Classes 2 through 4 to an expert for technical review, decided case by case, and when it applies it's the largest single cost: 38,000THB at Class 2 or 3, 53,000 THB at Class 4. That's not automatic, but in our experience it happens often, especially at Class 4, sowe tell clients to budget for it rather than hope to avoid it. Establishment licensing for the Thai entity is separate again. Timelines vary with MDCD's workload and application complexity, which is why we track current processing patterns directly rather thanquoting a fixed number.
 

13. Any regulatory changes in 2026 worth flagging?
 

Two. First, a bilateral reliance program with Malaysia went into full effect on 1 May 2026: manufacturers with an existing MalaysiaMDA approval may qualify to bypass the external expert evaluation step for Classes 2, 3, and 4, submitted with a full CSDTdossier. That's a real cost and time saving where it applies. Second, new labeling rules under B.E. 2568 (2025) came into force 20June 2026. The post-importation window for completing Thai-language labeling dropped from 180 days to 120 days, countedfrom the day the inspection checkpoint releases the shipment for import. Labels already approved under the old 2020 notification can stay in use until 20 June 2028, but any manufacturer still working to the old 180-day assumption is planning around a rulethat no longer applies.

14. What's the biggest risk in choosing a local partner as license holder?

Handing them de facto ownership of your Thai market access. The Establishment License and the device registration itself are heldby the Thai entity, and if that entity is a distributor rather than a genuine regulatory partner, a soured commercial relationship becomes a regulatory problem. Under Thai FDA's document transfer procedure, a new holder files its own application with a letterof consent from the current holder, and the old registration is cancelled once the new one is approved, so the manufacturer cannotmove without the current holder's cooperation. We act as Local Authorized Representative and Importer of Record specifically somanufacturers keep a regulatory partner in that seat, not a party with a commercial incentive to hold the registration hostage.

15. What SOPs or documentation should manufacturers have in place before they start?

A device description and Letter of Authorization at minimum, for every class. From Class 2 up, a current quality-system certificate(typically ISO 13485) and a full CSDT dossier prepared to ASEAN format, not adapted CE or FDA paperwork. Most technicaldocumentation can be in English, but some CSDT sections, such as the executive summary and device description, are expected inEnglish plus Thai under Thai FDA's CSDT guidance, so confirm the current list with the MDCD. Application forms and the IFU forhome-use devices must be in Thai. We typically run a gap analysis against the manufacturer's existing CE or FDA file beforedrafting anything new, because most of the underlying data is already there. It's the structure and the Thai-language obligationsthat trip people up.

16. What's your advice for a manufacturer about to start this process?

Get classification and the local holder relationship right before anything else. Both are structural decisions made before a singlesubmission document is prepared, and neither can be fixed mid-review. The device data is almost always sound by the time itreaches us. The failures we see sit upstream of the paperwork.
 

About DeeMED Consulting:
DeeMED Consulting is a Bangkok-based regulatory consulting firm led by Jerrod Lottinger, Co-Founder and Managing Director. Jerrod leads DeeMED's Thai FDA medical device registration services, and can be reached via Jerrod Lottinger's LinkedIn profile.