THAILAND · MEDICAL DEVICES

Thailand Medical Device Amendments: 2026 Guideline, Fees and System

A year after its general medical devices (GMD) and in vitro diagnostics (IVD) were registered in Thailand, a manufacturer’s head office announces a legal-manufacturer name change, two new models, a revised IFU and a new certification body for its ISO 13485 certificate. The Thai holder’s first question is not “which documents”, but “under the 2026 guideline, is each item evaluated before approval, auto-approved, or not amendable at all and in need of a new registration?”

The Thai FDA’s 2026 amendment guideline routes changes by change type, not by risk class. Within Class 2–4, some changes are evaluated by an officer or external expert before approval and others are approved automatically by the system; Class 1 has both kinds too. Fees, documents and the point of implementation all follow from that classification.

Which changes cannot go through an amendment at all?

Section 2 of the 2026 guideline first excludes non-amendable cases. A change in risk class that changes the certificate type (for example from detailed notification to licence), added products that cannot be grouped with the existing certificate, or a different generic name require a new product application. A change of product owner from legal entity A to entity B cannot be amended either; a merger in which the same legal entity continues can be. (Source: Thai FDA, หลักเกณฑ์การแก้ไขเปลี่ยนแปลงสำหรับงานผลิตภัณฑ์เครื่องมือแพทย์, 2026-03-16, §2.1–2.2)

Changing the Thai licence holder (importer) is not an amendment either: it is a transfer involving the original holder’s consent and cancellation of the original certificate (see related reading). Remove these cases first, then classify the remaining changes one by one.

How do “evaluated before approval” and “auto-approve” differ?

Section 3.1 lists changes evaluated before approval. For Class 2–4 there are eight types, mainly covering manufacturing site, process and quality system, design or specification, software, materials, labelling and IFU, and adding models to a group; an officer evaluates, with an external expert where needed. Class 1 also has changes requiring evaluation, such as label text and grouping changes. In the guideline, a minor change is evaluated by an officer before approval; a major change is evaluated by an external expert or an officer. (Source: Thai FDA, หลักเกณฑ์การแก้ไขเปลี่ยนแปลงสำหรับงานผลิตภัณฑ์เครื่องมือแพทย์, 2026-03-16, §3.1)

Section 3.2 lists changes approved automatically by the system. For Class 2–4: updated QMS certificate scope, change of certification body, ISO certificate updates, establishment information and removal of models. For Class 1: overseas manufacturer name or address without relocation, product-owner name after a merger, an updated declaration of conformity, removal of items, software information and establishment information. Auto-approval means the system grants approval; it is not the same as implementing on submission, so the system approval is the trigger. (Source: Thai FDA, หลักเกณฑ์การแก้ไขเปลี่ยนแปลงสำหรับงานผลิตภัณฑ์เครื่องมือแพทย์, 2026-03-16, §3.2)

How are fees calculated, and is the expert fee always charged?

Class 2–4 amendments cost THB 500 per application, paid after approval. The external expert fee applies only where an application actually needs expert evaluation; it is not a fixed charge on every “major” change: detailed notification manufacture THB 19,200, import THB 24,000; licence manufacture THB 24,000, import THB 30,000. Class 1 amendments are generally free, THB 15,000 where expert review is needed. The FDA payment notice governs the actual amount. (Source: Thai FDA, หลักเกณฑ์การแก้ไขเปลี่ยนแปลงสำหรับงานผลิตภัณฑ์เครื่องมือแพทย์, 2026-03-16, §3.1–3.2; Thai FDA, ค่าธรรมเนียม/ค่าใช้จ่าย, 2024-02-20)

Which documents are needed?

The guideline lists attachments per change type, so documents should be prepared against the list for that type rather than a single universal checklist. Technical changes commonly need a before/after comparison, a verification and validation (V&V) summary, risk analysis and updated labelling and IFU; reference-country approval evidence, clinical evidence or cybersecurity documents are needed only where the change type calls for them. (Source: Thai FDA, หลักเกณฑ์การแก้ไขเปลี่ยนแปลงสำหรับงานผลิตภัณฑ์เครื่องมือแพทย์, 2026-03-16)

In practice the comparison table causes most delays: head-office notices often just say “updated”, while the Thai file needs each difference spelled out. Align the comparison and the certificates needed with head-office RA before starting.

Where do timelines and the system stand now?

The Thai FDA announced the new amendment system on 2 March 2026 and published the new guideline on the amendment page on 16 March 2026; all amendments are filed electronically through Skynet. (Source: Thai FDA, เตรียมพร้อมเข้าสู่ระบบแก้ไขเปลี่ยนแปลงระบบใหม่, 2026-03-02; Thai FDA, หลักเกณฑ์การแก้ไขเปลี่ยนแปลงสำหรับงานผลิตภัณฑ์เครื่องมือแพทย์, 2026-03-16) In MediPass’s experience as a Thai licence holder, the new system is in use.

No uniform review timeline has been published for all change types under the new guideline. In 2024 the Thai FDA announced 15 working days for minor changes filed electronically, but it could not be confirmed that this applies to all applications under the new guideline, so it should not be treated as a commitment. Auto-approved changes are usually fastest; changes needing expert review should allow time for evaluation and queries. (Source: Thai FDA, FDA Shortened Duration on Permission Request, 2024-04-20)

What does this mean for planning?

Taking the opening change package (hypothetical, all on a Class 3 imported detailed notification): the new certification body for ISO 13485 is auto-approved at THB 500; the two added models and the IFU revision are evaluated before approval at THB 500 each, plus THB 24,000 if the officer refers them to an external expert; for the legal-manufacturer name change, check how the guideline classifies a name or address change without relocation for Class 2–4 before deciding whether to file it alone or together. Filing the auto-approve items first and scheduling evaluated changes separately keeps Thai supply from waiting on the slowest item. The holder files in Skynet and pays; the manufacturer delivers technical documents against the annex list on time.

Also consider why the change is happening: where a design or labelling change follows an adverse event or FSCA, the Thai FDA will look at the related event. If a ร.ม.พ.3 report is open in Thailand for the same product, one person should coordinate the amendment and the post-market reporting.