Explore the medical device requirements currently available for Thailand, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
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.
What expires, what is retained periodically, and when must renewal start?
Fixed Term
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).
Effective from 2019-05-01
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.
Effective from 2019-05-01
Waiver clause seen verbatim: ผู้จดแจ้งซึ่งใบรับจดแจ้งของตนสิ้นอายุไม่เกินหนึ่งเดือน จะยื่นคาขอต่ออายุและขอผ่อนผันโดยแสดงเหตุผล...; it does not lift liability under มาตรา ๙๑.
Renewal applications are filed no more than 90 days before expiry; after the one-month post-expiry window a new process is required.
90
no-earlier-than
5
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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.
Effective from 2019-05-01
Full CSDT
Other documents seen verbatim on the page: หนังสือยินยอมหรือรับรองให้มีการถ่ายโอนเอกสาร (Letter of Consent...); หนังสือรับรองแสดงความปลอดภัย (Safety Declaration).
Yes
30
Cancellation clause seen verbatim: เมื่อตำรับที่ขอถ่ายโอนเอกสารได้รับการอนุมัติ ทะเบียนตำรับแม่แบบจะถูกยกเลิก.
Which clinical or IVD performance evidence or study is required and accepted?
Clinical investigations of medical devices in Thailand must follow ISO 14155:2020 or ISO 20916:2019, as applicable.
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.
Is the product a device, IVD, accessory, software, or borderline product locally?
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.
Effective from 2019-05-01
Exclusion clause seen verbatim: ต้องไม่เกิดจากกระบวนการทางเภสัชวิทยา วิทยาภูมิคุ้มกัน หรือปฏิกิริยาเผาผลาญให้เกิดพลังงานเป็นหลัก. PDF text shows น้ายา for น้ำยา (extraction artifact).
Which evidence, local deltas, formats, and signatures are required?
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.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Registration Dossier Transfer With Consent
New Application Using Transferred Dossier
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.
Corrected: baseline handover extras (new manufacturer LoA, complaints/recalls file, Thai labels, import inventory) are not listed on the official transfer page; handover trimmed to documents actually shown.
Medical-device importers must appoint an import controller (ผู้ควบคุมการนำเข้าเครื่องมือแพทย์) who holds at least a bachelor's degree and has a residence in Thailand.
Qualification items seen verbatim: 1. เป็นผู้ที่สำเร็จการศึกษาขั้นต่ำปริญญาตรี 2. มีถิ่นที่อยู่ในประเทศไทย.
Which establishment licences, importer permissions, and distribution controls apply?
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).
Which label and IFU elements, languages, symbols, and translation controls apply?
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.
PDF extraction shows กากับ for กำกับ.
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.
Effective from 2026-06-20
Gazette reference seen verbatim: ประกาศราชกิจจานุเบกษา เล่ม 142 ตอนพิเศษ 397ง หน้า 19-24.
Which current law, regulation, guidance, and transition provisions apply?
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).
Effective from 2019-05-01
Gazette header: ราชกิจจานุเบกษา เล่ม ๑๓๖ ตอนที่ ๕๖ ก, ๓๐ เมษายน ๒๕๖๒.
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.
Effective from 2019-05-01
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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.
Which current form, portal, account, and submission package must be used?
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.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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).
Which recall, FSCA, notice, and authority-coordination duties apply?
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.
Which registration, notification, listing, reliance, or conformity route applies?
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.
Effective from 2019-05-01
The provision's third group (ค) กลุ่มเครื่องมือแพทย์หรือเครื่องมือแพทย์ที่ผู้ผลิตหรือผู้นาเข้าต้องจดแจ้อยู่ในบทเดียวกัน completes the three routes.
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).
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
Regulatory reference
Devices holding at least one qualifying approval from MDA-recognised authorities may use CAB conformity assessment by way of verification instead of full assessment: EU Notified Bodies (specified MDR/IVDR and legacy directive certificates), Japan MHLW (Ninsho/Shonin), Australia TGA (ARTG), Health Canada (licence), US FDA (510(k)/PMA), UK MHRA (UKCA for GB; EC/UKNI certificates for Northern Ireland), Singapore HSA (SMDR registration), Thailand FDA (Class 2-3 notified / Class 4 licensed device certificates).
Replaces the list formerly in MDA Circular Letter No. 1/2025 Annex 1; Second Edition (13 October 2025) added HSA and Thai FDA.
Regulatory reference
Thai FDA Class 2-3 Certificate of Notified Medical Device or Class 4 Certificate of Licensed Medical Device qualifies for the verification route.
Prior approval / evidence record
ASEAN member-state registration
No
There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:tha
Singapore HSA product registration
Assessment Report Reliance
facilitated
Product Marketing
Yes
Yes
Page also states verbatim: อย สามารถเข้าถึง evaluation report ที่ออกโดย HSA สิงคโปร์ได้ (Thai FDA can access the HSA evaluation report).
Prior approval / evidence record
geo:tha
EU CE under MDR/IVDR
Abridged Review
facilitated
Product Marketing
Yes
Yes
12
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Prior approval / evidence record
ASEAN Medical Device Directive (AMDD) harmonisation
The AMDD gives the ten member states one device definition, one set of classification rules, one set of essential principles and one dossier structure, the Common Submission Dossier Template. It is not a reliance route. The ACCSQ Medical Device Product Working Group states in terms that the Directive is "not intended to confer mutual recognition" and that each member state retains the sovereign right to make its own registration decisions, so a registration in one ASEAN market authorises nothing in another and shortens no national review period.
None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
FDA 510(k)
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:tha
Australia TGA/ARTG market authorization evidence
Abridged Review
facilitated
Product Marketing
Yes
Yes
12
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Prior approval / evidence record
geo:tha
ASEAN Common Submission Dossier Template
Harmonized Dossier Only
Evidence Only
Dossier Format
Yes
Yes
Thailand is party to the ASEAN agreement on medical-device provisions and aligns controls to it; Thai FDA registration-pathways page confirms submissions use รูปแบบ Common Submission Dossier Template (CSDT) — national registration and decision still required.
Prior approval / evidence record
class-3
Class 3
high
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-2
Class 2
medium
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:tha
Health Canada medical-device licence
Abridged Review
facilitated
Product Marketing
Yes
Yes
12
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Regulatory reference
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 FDA recognises: Australia TGA, Health Canada, EU Notified Bodies, Japan MHLW, US FDA and WHO Prequalification for IVDs. China's NMPA is not a recognised reference agency, so NMPA-registered devices are evaluated under the full pathway. The Singapore HSA reliance programme and the Malaysia MDA reliance programme (both held) are the only bilateral reliance channels and do not involve China.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
thailand
Class 2-4 devices and IVDs (detailed notification and licence routes); NMPA approvals do not qualify for the abridged pathway
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2024-06-04
Source passage: 2. การประเมินเอกสารแบบย่อ (Abridged pathway) สำหรับเครื่องมือแพทย์ที่มีประวัติการขึ้นทะเบียนจากหน่วยงานที่ อย. รับรอง ดังนี้ Therapeutic Goods Administration: TGA; Health Canada: HC; European Union Notified Bodies: EU NB; Japan Ministry of Health Labour and Welfare: MHLW; US Food and Drug Administration: US FDA; WHO Prequalification of in Vitro Diagnostics (IVD)
Prior approval / evidence record
geo:tha
Japan MHLW/PMDA Ninsho or Shonin
Abridged Review
facilitated
Product Marketing
Yes
Yes
12
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Prior approval / evidence record
geo:tha
US FDA 510(k), De Novo, or PMA
Abridged Review
facilitated
Product Marketing
Yes
Yes
12
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Prior approval / evidence record
class-4
Class 4
highest
Full Registration
300
300
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
Yes
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
What review, validation, and applicant stop-clock rules apply?
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.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Import of medical devices for individual patients or animals (case-by-case) is exempt from the licensing/notification requirement.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
Finality clause seen verbatim: คาวินิจฉัยของรัฐมนตรีให้เป็นที่สุด. Suspension/revocation orders are separately appealable and not automatically stayed.
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.
Which UDI, device listing, database, and traceability duties apply?
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).
What is reportable, by whom, where, in what format, and by what deadline?
Events involving death or serious injury must be reported immediately, at the latest within 10 days of becoming aware.
Effective from 2021-02-05
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.
Effective from 2021-02-05
Follow-up clause seen verbatim: การรายงานผลการติดตาม ให้รายงานภายในสามสิบวันนับจากวันที่ส่งรายงานเบื้องต้น.
Events constituting a serious threat to public health must be reported immediately, at the latest within 48 hours of becoming aware.
Effective from 2021-02-05
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.
Effective from 2021-02-05
February deadline seen verbatim: ถึงธันวาคม ให้รายงานภายในเดือนกุมภาพันธ์.
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.
Effective from 2021-02-05
21-day clause seen verbatim: การรายงานผลการติดตามหรือรายงานฉบับสุดท้าย ให้รายงานภายในยี่สิบเอ็ดวันนับจากวันที่รายงานฉบับก่อนหน้านั้น.
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.
Effective from 2021-02-05
Notification effective 60 days after gazette publication (๗ ธันวาคม ๒๕๖๓).
thailand:medical-device
thailand
Risk classes 1 through 4.
1
Class 1
low
2
Class 2
medium
3
Class 3
high
4
Class 4
highest
Thai FDA
official-source-verified
Thai FDA — medical device registration (class/route table; MoPH notification on risk-based classification B.E. 2562)
https://medical.fda.moph.go.th/product/category/about-product-registration
2026-08-25
Thailand
thailand
TH
🇹🇭
Thai Food and Drug Administration
Thai FDA
asia-pacific
2
4-class (1, 2, 3, 4)
class-1
Class 1
low
Notification
200
200
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
0
2
months
No
No
No
class-2
Class 2
medium
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
class-3
Class 3
high
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
class-4
Class 4
highest
Full Registration
300
300
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
Yes
Yes
Yes
ASEAN Medical Device Directive (AMDD) harmonisation
The AMDD gives the ten member states one device definition, one set of classification rules, one set of essential principles and one dossier structure, the Common Submission Dossier Template. It is not a reliance route. The ACCSQ Medical Device Product Working Group states in terms that the Directive is "not intended to confer mutual recognition" and that each member state retains the sovereign right to make its own registration decisions, so a registration in one ASEAN market authorises nothing in another and shortens no national review period.
None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
FDA 510(k)
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
None published
EU CE Mark
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
None published
ASEAN member-state registration
No
There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
None
Yes
No
Not accepted but ISO 13485 required
5 years
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"
https://www.ahwp.info/sites/default/files/6%20Implementing%20the%20ASEAN%20Medical%20Device%20Directive%201.0.pdf
2026-08-30
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by Thai FDA. Appoint a local representative where required.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Thai FDA including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Thai FDA reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. Thai FDA may issue questions.
200 days
⚙️
5
Registration Approval
Upon successful review, Thai FDA issues Thailand market authorization certificate.
1-2 weeks
✅
Thailand
thailand
TH
TFDA
1800
3100
THB
Yes
36400
74000
THB
Yes
class-1-application
Class 1 - Application
THB
500
THB 500
Per application
Same for local manufacture and import
official-verified
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Thai FDA manufacture/import fee table
2026-08-25
exact-current
class-1-document-verification-import
Class 1 - Document Verification (Import)
THB
600
THB 600
Per application
Local manufacture: THB 300
official-verified
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Thai FDA manufacture/import fee table
2026-08-25
exact-current
class-1-certificate-import
Class 1 - Certificate (Import)
THB
2000
THB 2,000
Per certificate
Local manufacture: THB 1,000; import total: THB 3,100
official-verified
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Thai FDA manufacture/import fee table
2026-08-25
exact-current
class-2-3-application
Class 2/3 - Application
THB
1000
THB 1,000
Per application
Same for local manufacture and import
official-verified
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Thai FDA manufacture/import fee table
2026-08-25
exact-current
class-2-3-expert-fee-import
Class 2/3 - Expert Fee (Import)
THB
38000
THB 38,000
Per application
Local manufacture: THB 30,400
official-verified
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Thai FDA manufacture/import fee table
2026-08-25
exact-current
class-2-3-certificate-import
Class 2/3 - Certificate (Import)
THB
10000
THB 10,000
Per certificate
Local manufacture: THB 5,000; import total: THB 49,000
official-verified
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Thai FDA manufacture/import fee table
2026-08-25
exact-current
class-4-application
Class 4 - Application
THB
1000
THB 1,000
Per application
Same for local manufacture and import
official-verified
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Thai FDA manufacture/import fee table
2026-08-25
exact-current
class-4-expert-fee-import
Class 4 - Expert Fee (Import)
THB
53000
THB 53,000
Per application
Local manufacture: THB 42,400
official-verified
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Thai FDA manufacture/import fee table
2026-08-25
exact-current
class-4-certificate-import
Class 4 - Certificate (Import)
THB
20000
THB 20,000
Per certificate
Local manufacture: THB 10,000; import total: THB 74,000
official-verified
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Thai FDA manufacture/import fee table
2026-08-25
exact-current
importer-establishment-registration
Importer establishment registration - statutory certificate fee
THB
4000
THB 4,000
Per certificate
exact-current
official-verified
https://medical.fda.moph.go.th/media.php?id=481145798093053952&name=กฎกระทรวง กำหนดค่าธรรมเนียมเกี่ยวกับเครื่องมือแพทย์ พ.ศ. 2563.pdf
Thailand Ministerial Regulation on medical-device fees B.E. 2563 (2021), Royal Gazette
2021-03-17
2026-08-25
2026-08-25
official-verified
Thai FDA manufacture/import fee table
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
2026-08-25
Thailand Ministerial Regulation on medical-device fees B.E. 2563 (2021), Royal Gazette
https://medical.fda.moph.go.th/media.php?id=481145798093053952&name=กฎกระทรวง กำหนดค่าธรรมเนียมเกี่ยวกับเครื่องมือแพทย์ พ.ศ. 2563.pdf
2021-03-17
2026-08-25
2026-08-25
exact-current
Yes
thailand
Thailand
low
thai-fda-electrical-emc-evidence
Thai FDA electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
Thai FDA's new-importer dossier table requires summary verification and validation for the full Class 2–4 pathway, with the applicable evidence dependent on the device and pathway; its Class 1 table calls for testing or calibration evidence for measuring devices. The cited clinical-investigation ISO 14155/20916 requirements do not by themselves establish an electrical-safety or EMC certificate rule. A specific national electrical/EMC overlay is not established by these reviewed sources.
reviewed
nbtc-sdoc
NBTC SDoC
Radio Spectrum
Mandatory If Feature
Eligible Radio Equipment
candidate
nbtc-class-a
NBTC Class A
Radio Spectrum
Mandatory If Feature
Eligible Radio Equipment
candidate
nbtc-class-b
NBTC Class B
Radio Spectrum
Mandatory If Feature
Eligible Radio Equipment
candidate
tisi-compulsory-standards-mark
TISI compulsory standards mark
General Electrical Components
Mandatory If Feature
Listed Product Or Component
unresolved
halal-certification
Halal certification
Halal And Material Origin
Voluntary Or Procurement
Eligible Product Or Claim
unresolved
oap-radiation-generator-licence
OAP radiation-generator licence
Ionizing Radiation
Mandatory If Feature
Product And Use Site
The OAP-authored regulatory-framework presentation hosted by IAEA (pages 19–21) distinguishes licensing from notification under the Nuclear Energy for Peace Act: Category 1 (at least 1 MeV) and Category 2 (below 1 MeV, not fully enclosed during operation) generators require OAP licensing; fully enclosed Category 3 generators below 1 MeV follow OAP notification and regular safety inspection. Generators specifically designed for medical diagnostics follow the Ministry of Public Health notification route; generators with maximum energy at or below 5 keV are listed as exempt. For the licensed categories, the presentation gives five-year production/possession/use licences and import/export/transit licences of no more than six months. Confirm the current category and implementing instrument for the specific device; this framework presentation does not establish a blanket licence requirement for all non-diagnostic generators.
reviewed
thai-fda-import-licensing
Thai FDA import establishment licensing
Import Conformity
Mandatory At Import
Commercial Importer
Thai FDA's new-importer customer journey first routes Section 27-exempt purposes to their separate exemption procedure. For non-exempt commercial imports, it requires import-establishment registration before product registration. The page lists separate establishment charges: THB 100 application, THB 12,000 assessment and THB 4,000 certificate; THB 4,000 is not the total charge. Registered importers must provide an import supervisor, required signage and the import/sale quality system under the MOPH Notification B.E. 2566 (2023). The reviewed page does not establish that every Section 27 case follows the same permission route.
reviewed
NBTC
telecommunications equipment standards and SDoC/Class A/Class B
https://standard1.nbtc.go.th/
Thai FDA
IDE clinical investigation standards ISO 14155 and ISO 20916
https://medical.fda.moph.go.th/ide-head/category/ide-02
Office of Atoms for Peace
Nuclear Energy for Peace Act B.E. 2559 framework and OAP mandate
https://www.oap.go.th/en/overview-of-office-of-atoms-for-peace
IAEA (GNSSN)
Thailand nuclear/radiation regulatory framework — OAP vs MOPH split for radiation generators, licence classes and validity
https://gnssn.iaea.org/main/ansn/Activity%20Documents%20%20Public/Expert%20Mission%20to%20Thailand%20on%20the%20Development%20of%20National%20Waste%20Policy%20and%20Regulatory%20Requirements%20for%20RWM/NucLaw-IRRS-1.pdf
Thai FDA (Medical Device Control Division)
New medical-device importer customer journey — import establishment registration before listing, Section 27 purpose categories
https://medical.fda.moph.go.th/customer-journey/%20newimporter
