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Thai FDA · South & Southeast Asia

Thailand medical device regulatory resources

Every Thailand dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

4,441,287 license record records11 free resources24/25 topics with records8 regulations trackedAug 2026 fees reviewed

Everything we track for Thailand

Structured regulatory requirements

Explore all 50 source-linked facts

24 of 25 research dimensions currently covered · 24 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
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 e…
1 source-linked fact
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Primary legislation and effective date
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 Roya…
Transition of pre-amendment licences
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.
2 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Medical-device definition (incl. software and IVD reagents)
A medical device (เครื่องมือแพทย์) includes instruments, appliances, machines, objects inserted into the body, IVD reagents, products, software and other articles intended by the manufactur…
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

Verified
Risk classes 1 through 4.
Class 1, Class 2, Class 3, Class 4
1 maintained scheme
Checked 2026-08-25
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D05

Registration pathways

Verified
Market-access route by risk class
Route depends on the risk based group of the device: licence route (ขออนุญาต, ใบอนุญาต), detailed notification route (แจ้งรายการละเอียด, ใบรับแจ้งรายการละเอียด), or notification route (จดแจ…
Submission tracks: Full / Abridged / Reliance
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 r…
2 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
China NMPA approval: not reference
statement: Thai FDA offers two submission channels: the full pathway and the abridged evaluation pathway, the latter reserved for devices with a registration history from the agencies Thai…
ASEAN Common Submission Dossier Template — harmonized dossier only
target: geo:tha · sourceApproval: ASEAN Common Submission Dossier Template · edgeType: harmonized dossier only · marketAccessStrength: evidence only · regulatoryLayer: dossier format · loca…
8 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Representative or holder change
path code: registration dossier transfer with consent · fresh registration: new application using transferred dossier · minimum handover: declaration of identicality; consent to dossier tra…
Import controller qualifications
Medical device importers must appoint an import controller (ผู้ควบคุมการนำเข้าเครื่องมือแพทย์) who holds at least a bachelor's degree and has a residence in Thailand.
2 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Importer establishment prerequisite
An importer must complete importer establishment registration (จดทะเบียนสถานประกอบการนำเข้า) before it can file medical device registration applications.
Checkpoint import inspection
Import of medical devices must pass inspection by officials at medical device inspection checkpoints (ด่านตรวจสอบเครื่องมือแพทย์) once the checkpoint locations are announced under มาตรา ๖ (…
2 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Class-4 licence dossier: quality-system certificate
The class 4 licence application must include, among the documents listed in ข้อ ๒, a quality system certificate (หนังสือรับรองระบบคุณภาพ).
Dossier format (CSDT)
Technical documentation is submitted in the Common Submission Dossier Template (CSDT) format.
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
E-submission portal (SKYNET)
Medical device registration documents are filed electronically through the SKYNET e submission system.
Vigilance reporting channel (SKYNET HPVC, forms รมพ. 1-3)
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.
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Label/IFU duty
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…
Labelling notification B.E. 2568 effective date
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 20…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Quality system for import/sale (2566)
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).
1 source-linked fact
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
Thai FDA electrical/EMC evidence
Electrical safety
NBTC SDoC
Wireless / radio
NBTC Class A
Wireless / radio
8 maintained overlays
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Class 1 - Application
THB 500
Class 1 - Document Verification (Import)
THB 600
10 maintained fee lines
Checked 2026-08-25
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D15

Review clocks

Verified
Class 1 · Notification
200 days
Class 2 · Registration
250 days
Class 3 · Registration
250 days
4 maintained pathways · 1 related fact
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Authorization duration
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).
Expiry or lapse consequence
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 s…
5 source-linked facts
Checked 2026-08-26
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Lifecycle & post-market

D17

Change control

Verified
Notification-data change duty
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 au…
Registration-dossier transfer package
applicationFormat: Full CSDT · additionalDocuments: declaration of identicality; letter of consent; safety declaration
3 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
UDI status
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).
1 source-linked fact
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical-investigation standards
Clinical investigations of medical devices in Thailand must follow ISO 14155:2020 or ISO 20916:2019, as applicable.
Clinical-data triggers
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…
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Individual-patient import exemption
Import of medical devices for individual patients or animals (case by case) is exempt from the licensing/notification requirement.
1 source-linked fact
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Annual report deadline
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.
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Death or serious injury deadline
Events involving death or serious injury must be reported immediately, at the latest within 10 days of becoming aware.
Recurrence-risk deadline and follow-up
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…
6 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Authority recall power
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 th…
1 source-linked fact
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Advertising permit requirement
Advertising a medical device requires a prior advertising permit (ใบอนุญาตโฆษณาเครื่องมือแพทย์); permit categories cover advertising to the public and advertising by giveaway items (gimmick…
Professional-audience exemption
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…
2 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Appeal to the Minister (30 days, final)
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…
Refusal notice with reasons (15 days)
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.
2 source-linked facts
Checked 2026-08-25
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TFDA registration fees in THB · reviewed 2026-08-25

Fee lineAmountProvenance
Class 1 - ApplicationTHB 500Verified
Class 1 - Document Verification (Import)THB 600Verified
Class 1 - Certificate (Import)THB 2,000Verified
Class 2/3 - ApplicationTHB 1,000Verified
6 more fee lines on the full schedule · 10 of 10 rows source-verified

Registration timeline

Full registration timeline

Thai Food and Drug Administration (Thai FDA) review clocks and planning ranges · 4-class (1, 2, 3, 4) classification

Class / pathwayReview clockPlanning totalProvenance
Class 1(Notification)200 days0-2 monthsVerified
Class 2(Registration)250 days4-5 monthsVerified
Class 3(Registration)250 days4-5 monthsVerified
Class 4(Full Registration)300 days4-5 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(200 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Thailand regulation news

Newest official Thai FDA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Official Thai FDA rules and guidance · 8 of 8 documents linked to official sources

Thai FDA Notification B.E. 2567 (9 May 2024)Information, Documents, or Evidence Not Required under Medical-Device Manufacture/Import Licensing and Detailed-Notification Regulations
RegistrationVerified
Thai FDA Risk Classification GuidanceRisk Classification Rules for Medical Devices and IVDs
ClassificationVerified
Thai FDAThailand Food and Drug Administration - Medical Devices
GeneralVerified
Class 4 LicensingDevice Licensing for Class 4 - Active Medical Device Division
RegistrationVerified

Computed from 4,441,287 official Thai FDA license record records · data as of 2026-08-26

4,441,287
License records
3,835
Licensees
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