THAILAND · MEDICAL DEVICES

Thailand medical device submission types and CSDT requirements: from risk class to document list

Preparing a Thai medical device dossier means answering two questions in turn. First, which risk class is the product in, and which statutory application does that class require? Under the Ministry of Public Health (MOPH) notifications, Class 4 devices need a Licence, Class 2 and Class 3 devices need a Notification (detailed listing), and Class 1 devices need a Listing. Second, for a Class 2–4 application, will you file a Full CSDT, an Abridged dossier or a reliance submission, and what does each route require? (Source: MOPH risk classification notification B.E. 2562, clause 5) Only by keeping the two questions separate can you estimate the technical documentation workload accurately.

This article is for manufacturers of general medical devices (GMD) and in vitro diagnostics (IVD) for human use who plan to import into Thailand commercially. It focuses on turning a classification decision into a workable document list. For local licence-holder arrangements, grouping and the overall process, see MediPass Thailand medical device registration.

Step 1: the risk class determines the statutory application

The MOPH risk classification notification of B.E. 2562 (2019) divides medical devices into IVDs and non-IVDs, each in Class 1 to Class 4. Clause 5 sets out three control measures. Three implementing notifications of B.E. 2563 (2020) list the products in each category; all three were published in the Royal Gazette on 15 February 2021. (Sources: Licence notification; Notification notification (No. 2); Listing notification)

(Source: Erratum to the Listing ministerial regulation, clause 2(3))

Classify according to the intended use, users and principle of operation for the Thai market, applying the rules in the relevant annex. Where several rules apply, the highest class governs. Do not simply carry over another country’s class number. Thai FDA offers an online self-classification tool, which we suggest using for an initial view only; under clause 4 of the B.E. 2562 notification, classification disputes are decided by the FDA Secretary-General. Clause 9 of the Notification notification and clause 7 of the Licence notification also provide that where a specific notification already covers a product, that notification applies. So check whether your product is subject to its own specific rules as well.

Step 2: how Full CSDT, Abridged and reliance dossiers differ

The CSDT is the format for organising technical documentation; Full, Abridged and reliance are three assessment routes with different document sets. The table below combines Thai FDA’s IVD checklists issued in May 2026 with a presentation by Thai FDA’s Medical Device Control Division on the Abridged route. The presentation is undated, so treat the reliance column as background and confirm against Thai FDA’s current list before filing. The screening conditions and checklist requirements in the sections below come from the IVD checklists and should not be applied to GMDs as they stand. (Sources: IVD Full CSDT checklist; IVD Abridged checklist; Thai FDA presentation)

So an Abridged dossier drops the Summary V&V and the risk management file, replacing them with reference approval and three declarations. A reliance submission does not drop them; it relies on the review HSA has already done. Before choosing a route, confirm that the product actually qualifies. Recognition of Malaysian MDA approvals has its own conditions; see Thai FDA recognition of Malaysia MDA.

Can an IVD use the Abridged route? Three screening tests first

Part 1 of Thai FDA’s Abridged checklist for IVD Class 2–4 (IVD_MDCD_CL_AB Rev.1, 25 May 2026) sets three screening conditions, all of which must be met. (Source: IVD Abridged checklist, p. 1)

• Registration history: at least one year’s registration with an agency Thai FDA recognises: TGA, Health Canada, an EU Notified Body, Japan’s MHLW, the US FDA or WHO prequalification. Approvals that involve no assessment of quality, safety and performance, such as Listing, Class A/Class 1 or export-only approvals, do not count.
• Not specially controlled: the product is not an HIV test kit, HIV self-screening kit or methamphetamine urine test kit controlled by a specific MOPH notification.
• Safety record: no serious adverse events and no open field safety corrective actions (FSCAs) since the product was placed on the market.

Passing the screen does not guarantee that the review will stay abridged: the checklist notes that where reviewers have doubts about quality, performance or safety, they may request further information or refer the file to external experts. Note also that the required approval evidence depends on the agency and class. Under the EU IVDR, for example, Class A (non-sterile) needs only the DoC; Class A (sterile), B and C also need a QMS certificate from a Notified Body; near-patient, self-testing and companion diagnostic devices and Class D also need a technical documentation assessment certificate. (Source: as above, item 12) This article reviews the IVD checklists only; for GMD, check Thai FDA’s corresponding GMD checklists.

Four IVD Full CSDT requirements that are easy to underestimate

The following points come from Thai FDA’s Full CSDT checklist for IVD Class 2–4 (IVD_MDCD_CL_FU Rev.01, 25 May 2026). Thai FDA’s IVD documents page states that the checklists and evaluation forms revised on 25 May 2026 apply to applications whose fee is paid from 1 July 2026; the 2025 labelling notification took effect on 20 June 2026. All four points apply to IVDs; for GMDs, check Thai FDA’s corresponding GMD checklist. (Sources: Thai FDA IVD application documents page; IVD Full CSDT checklist, pp. 1, 3, 13 and 19)

• Clinical report depth rises with class: following IMDRF (GHTF/SG5/N8:2012), Class 2 needs only a summary of the study protocol, results and conclusion; Class 3 needs a full report; Class 4 needs a full report plus raw data.
• QMS certificate scope: ISO 13485 should cover design and development, manufacturing and distribution. Where a separate physical manufacturer is involved, certificates for both the product owner and the physical manufacturer are required; if the scope is incomplete, attach an audit report.
• Specially controlled products: products such as HIV tests that fall under a specific notification also need test results from Thailand’s Department of Medical Sciences.
• Language and filing: documents are prepared by the product owner or manufacturer in English (Thai manufacturers may use Thai) and filed through the e-submission system; foreign manufacturers cannot file with Thai FDA directly. Labels and IFUs must also comply with the B.E. 2568 labelling notification, in force from 20 June 2026.

Older project files may refer to earlier route names such as “Partial”. The 2026 IVD checklists cover only Full CSDT and Abridged. For existing products filed as Partial 2, where some documents were exempt and not yet submitted, Thai FDA’s IVD documents page answers that after five years, if the company wants to keep manufacturing or importing, it must apply for renewal and can use the “supplementary documents system” (ระบบเพิ่มเติมเอกสาร) to convert the application from Partial to Full CSDT. A new application cannot rely on old records to follow the Partial route. (Source: Thai FDA IVD application documents page)

Illustrative example: what a CE certificate does and does not tell you

This is a hypothetical example and does not represent the formal classification or outcome for any product. A manufacturer plans to import a professional-use IVD that falls into Class 2 under the Thai rules, so the statutory application is a Notification. The product holds an EU IVDR Class B Notified Body certificate and has been registered in the EU for 18 months.

A quotation can be estimated on an Abridged basis, provided it states that this assumes written evidence can be obtained for every row. If any point cannot be shown before filing, the dossier must be prepared as a Full CSDT, so allow for the Summary V&V and risk management file.

Manage the submission scope with a consistency matrix

The following is a project-management approach suggested by MediPass, not an official form. The checklists require the same information to match across several documents; turning those requirements into a matrix lets you resolve mismatches before translation and signing. (Sources: IVD Abridged checklist, pp. 2–3; IVD Full CSDT checklist)

Resolve differences in intended use, users and model scope first, because they decide which reports can be shared and whether the reference approval applies. Then plan translation, additional testing and the documents the manufacturer must sign.