🇹🇭 Thailand medical device regulatory data

DaysBeforeExpiry

90

Direction

no-earlier-than

Years

5

Type

Fixed Term

Description

Notification receipts (ใบรับจดแจ้ง) are valid for 5 years from the date shown on the receipt; renewal extends validity for a further 5 years (renewal FAQ).

Renewal applications are not accepted once more than one month has passed since expiry; within one month after expiry the holder may still apply for renewal together with a waiver request showing cause, paying the renewal fee.

Renewal applications are filed no more than 90 days before expiry; after the one-month post-expiry window a new process is required.

ApplicationFormat

Full CSDT

AdditionalDocuments

• declaration-of-identicality
• letter-of-consent
• safety-declaration

MasterRegistrationCancelledAfterApproval

Yes

FormerHolderClosureDeadlineDays

30

Where information already notified (จดแจ้อยู่) changes, the notifier must report the changed information to the licensing authority, following criteria, methods and conditions set by the authority.

Path Code

Registration Dossier Transfer With Consent

Fresh Registration

New Application Using Transferred Dossier

Minimum Handover

• declaration of identicality
• consent to dossier transfer (letter of consent)
• safety declaration
• registration dossier (Full CSDT)

Notes

The transferee files a Full CSDT application; once it is approved the master registration is cancelled — transfer enables a new application rather than editing the holder field.

Medical-device importers must appoint an import controller (ผู้ควบคุมการนำเข้าเครื่องมือแพทย์) who holds at least a bachelor's degree and has a residence in Thailand.

Thai FDA (สำนักงานคณะกรรมการอาหารและยา) under the Ministry of Public Health administers the Medical Device Act B.E. 2551 (2008) as amended; the Minister of Public Health has charge of and enforces the Act.

Medical Device Act B.E. 2551 (2008), as amended by Medical Device Act (No. 2) B.E. 2562 (2019), is the governing statute; the amendment took effect the day after its publication in the Royal Gazette (published 30 April 2019).

Licences and detailed-listing receipts issued under the Medical Device Act B.E. 2551 before Act (No. 2) B.E. 2562 took effect remain valid until their expiry.

A medical device (เครื่องมือแพทย์) includes instruments, appliances, machines, objects inserted into the body, IVD reagents, products, software and other articles intended by the manufacturer/product owner for specified uses in humans or animals (diagnosis, prevention, monitoring, treatment, injury care, life support, etc.), and excludes articles whose principal action results from pharmacological, immunological or metabolic processes.

Route depends on the risk-based group of the device: licence route (ขออนุญาต, ใบอนุญาต), detailed-notification route (แจ้งรายการละเอียด, ใบรับแจ้งรายการละเอียด), or notification route (จดแจ้ง, ใบรับจดแจ้ง); applied for by the registered manufacturer or importer.

Thai FDA accepts three submission tracks: Full evaluation (CSDT dossier), Abridged (device already registered for at least 1 year by a Big-5 reference agency), and Reliance (Singapore HSA registration with registrant consent).

Target

geo:tha

SourceApproval

Australia TGA/ARTG market authorization evidence

EdgeType

Abridged Review

MarketAccessStrength

facilitated

RegulatoryLayer

Product Marketing

LocalApplicationRequired

Yes

TargetDecisionRetained

Yes

MarketingHistoryMonths

12

Target

geo:tha

SourceApproval

EU CE under MDR/IVDR

EdgeType

Abridged Review

MarketAccessStrength

facilitated

RegulatoryLayer

Product Marketing

LocalApplicationRequired

Yes

TargetDecisionRetained

Yes

MarketingHistoryMonths

12

Target

geo:tha

SourceApproval

Health Canada medical-device licence

EdgeType

Abridged Review

MarketAccessStrength

facilitated

RegulatoryLayer

Product Marketing

LocalApplicationRequired

Yes

TargetDecisionRetained

Yes

MarketingHistoryMonths

12

Target

geo:tha

SourceApproval

Japan MHLW/PMDA Ninsho or Shonin

EdgeType

Abridged Review

MarketAccessStrength

facilitated

RegulatoryLayer

Product Marketing

LocalApplicationRequired

Yes

TargetDecisionRetained

Yes

MarketingHistoryMonths

12

Target

geo:tha

SourceApproval

US FDA 510(k), De Novo, or PMA

EdgeType

Abridged Review

MarketAccessStrength

facilitated

RegulatoryLayer

Product Marketing

LocalApplicationRequired

Yes

TargetDecisionRetained

Yes

MarketingHistoryMonths

12

Target

geo:tha

SourceApproval

Singapore HSA product registration

EdgeType

Assessment Report Reliance

MarketAccessStrength

facilitated

RegulatoryLayer

Product Marketing

LocalApplicationRequired

Yes

TargetDecisionRetained

Yes

Target

geo:tha

SourceApproval

ASEAN Common Submission Dossier Template

EdgeType

Harmonized Dossier Only

MarketAccessStrength

Evidence Only

RegulatoryLayer

Dossier Format

LocalApplicationRequired

Yes

TargetDecisionRetained

Yes

An importer must complete importer-establishment registration (จดทะเบียนสถานประกอบการนำเข้า) before it can file medical-device registration applications.

Import of medical devices must pass inspection by officials at medical-device inspection checkpoints (ด่านตรวจสอบเครื่องมือแพทย์) once the checkpoint locations are announced under มาตรา ๖ (๑๗).

The class-4 licence application must include, among the documents listed in ข้อ ๒, a quality-system certificate (หนังสือรับรองระบบคุณภาพ).

Technical documentation is submitted in the Common Submission Dossier Template (CSDT) format.

Medical-device registration documents are filed electronically through the SKYNET e-submission system.

Adverse-event and field-safety-corrective-action reports are submitted via the HPVC channel of the SKYNET system, the main channel for receiving forms รมพ. 1, 2 and 3.

Registered establishments, licensees, detailed-listing notifiers and notifiers that manufacture or import devices must provide labels and accompanying documents (IFU) that do not show false or exaggerated statements; display follows ministerial-notification criteria, and sellers must ensure labels/IFU are present.

The Ministerial Notification on medical-device labelling B.E. 2568 (announced 27 November 2025; Royal Gazette เล่ม 142 ตอนพิเศษ 397 ง, pages 19-24, 22 December 2025) takes effect 20 June 2026.

Import or sale of medical devices must comply with the Ministerial Notification on quality systems for import or sale of medical devices B.E. 2566 (2023).

If a detailed-notification applicant fails to correct the application or supply missing information within the period set by the authority, the applicant is deemed not to wish to proceed and the authority strikes the case from the file register.

UDI is not yet required in Thailand: the Thai FDA FAQ states that UDI is not currently in use and the implementation timeline is not yet fixed (readiness activities are ongoing).

Devices whose clinical data are insufficient to demonstrate compliance with the essential principles of clinical safety and performance require clinical-investigation data for the clinical evaluation supporting a licence or detailed-notification application; such studies are conducted under IDE permission.

Clinical investigations of medical devices in Thailand must follow ISO 14155:2020 or ISO 20916:2019, as applicable.

Import of medical devices for individual patients or animals (case-by-case) is exempt from the licensing/notification requirement.

Four categories of operators (including manufacturers and importers of medical devices) must submit annual reports for the preceding year by 31 March of the following year.

Registered establishments, licensees, detailed-listing notifiers and notifiers must report device malfunctions (ผลการทำงานอันผิดปกติ) and adverse events (เหตุการณ์อันไม่พึงประสงค์) affecting consumers, wherever they occur (domestic or foreign), to the Thai FDA within prescribed periods.

Events constituting a serious threat to public health must be reported immediately, at the latest within 48 hours of becoming aware.

Events involving death or serious injury must be reported immediately, at the latest within 10 days of becoming aware.

Where scientific data or evidence indicate that recurrence could lead to death or serious injury, the initial report is due within 30 days of awareness; follow-up reports are due within 30 days of submitting the initial report.

Events occurring outside Thailand are reported twice a year: events in January-June by August, and events in July-December by February, plus any additional reports requested by the Thai FDA; devices produced and sold only in Thailand follow the domestic timelines.

Field safety corrective actions (domestic and foreign): initial report within 48 hours of becoming aware that an FSCA will be carried out; follow-up or final report within 21 days of the previous report.

The Secretary-General of the Thai FDA may order manufacturers, importers or sellers to recall devices from the market within a period the Secretary-General prescribes; the operator bears the costs of the recall and any destruction or disposal ordered.

Advertising a medical device requires a prior advertising permit (ใบอนุญาตโฆษณาเครื่องมือแพทย์); permit categories cover advertising to the public and advertising by giveaway items (gimmick) versus other forms.

Advertising directed at medical and public-health professionals can be exempted from the advertising permit by ministerial notification, which sets the devices and the criteria, methods and conditions of the exemption.

Refusals (non-issuance or non-renewal of establishment registration, licence, detailed-listing receipt or notification receipt) may be appealed in writing to the Minister within 30 days of receiving notice; the Minister's decision is final, and for non-renewal appeals the Minister may allow the operator to continue business pending decision.

When a detailed-notification application is refused, the authority must send written notice to the applicant with the reasons and appeal rights within 15 days of the refusal order.