Thai FDA Medical Device Registration Thailand

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 licence. That is why classification is the starting point of every consultation.

Often it is not even clear whether the product is a medical device. Cosmetic coloured lenses are medical devices, and veterinary medical devices are Class 1 as a rule. 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.

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.

Selling requires a separate sales licence and the appointment of a qualified sales controller. Brands without a Thai entity look at establishment registration and license holding under our Thai entity.

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 labelling must be checked again against the scope of the Thai application. When filing a detailed listing or licence 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 and must be in English. Labels and accompanying documents (including the IFU) follow the FDA's drafting guidelines, and the e-Submission document-preparation guide covers the labelling requirements as well.

Abridged evaluation based on the Singapore HSA reliance route and approvals from major reference countries is considered when the class and detailed conditions are met. An overseas approval does not apply automatically; what matters is that product name, model, product code, intended use and indications match. In-vitro diagnostics (IVD) have their own registration guide and document examples, and some items, such as HIV test kits, are controlled separately. A Research Use Only (RUO) label on its own does not allow sale without registration.

Advertising aimed at the general public requires a formal licence (ฆพ.1). Advertising made directly to medical and public-health professionals is exempt from the licence, 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 licence, 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.

• Assuming the class and then building the documents. Confirm it first with the classification determination tables and the determination system.
• Preparing product documents before the establishment is registered. The filing is not accepted at all.
• Preparing the DoC in Thai or in the importer's name. The product owner or actual manufacturer prepares it in English.
• Expecting an overseas approval to skip the Thai review. At most, abridged evaluation is considered for classes that meet the conditions.
• Running consumer advertising as if it were professional advertising. Consumer advertising requires a formal licence.
• Using an RUO label to avoid registration. Labelling method and permitted buyers have their own guidance.

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.