Thai FDA · structured requirements

🇹🇭 Thailand IVD regulatory data

Explore the IVD requirements currently available for Thailand, organized by topic and linked to official sources.

1 facts1 dimensions1 official sourceslatest verification 2026-09-15

Changes after registration

Common questions about changing a registered IVD in Thailand. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

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.

Thailand approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Thailand (8 records)

ThailandASEAN

Prior approval / evidence record

ASEAN member-state registration

Authority: ASEAN member-state registration
Accepted: No
Benefit: There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
Timeline Savings: None

Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)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"

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ThailandASEAN

Prior approval / evidence record

ASEAN Medical Device Directive (AMDD) harmonisation

Name: ASEAN Medical Device Directive (AMDD) harmonisation
Description: 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.
Timeline Reduction: None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Eligibility: Any device filed in an ASEAN member state that has transposed the AMDD into national law

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ThailandUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ThailandEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ThailandUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · WHO

Prior approval / evidence record

Class 3

class-3

Class Name

Class 3

Risk Level

high

Pathway

Registration

Official Timeline

Min: 250
Max: 250
Unit: days

Verification Status

official-verified

Official Source

Title: Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
Url: https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 5
Unit: months

Prior Approval Benefits

FDA
EU CE Mark
Japan
TGA
Health Canada
WHO (for IVD)

Notes

Statutory cap: class-3 registration decided within 250 days (Ministerial Regulation B.E. 2563 ข้อ ๖)
Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file
Clinical data may be required

Clinical Trial Required

Local Testing Required

Yes

Gmp Required

Yes

Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ThailandUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · WHO

Prior approval / evidence record

Class 2

class-2

Class Name

Class 2

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 250
Max: 250
Unit: days

Verification Status

official-verified

Official Source

Title: Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
Url: https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 5
Unit: months

Prior Approval Benefits

FDA
EU CE Mark
Japan
TGA
Health Canada
WHO (for IVD)

Notes

Statutory cap: class-2 registration decided within 250 days (Ministerial Regulation B.E. 2563 ข้อ ๖)
Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file
ASEAN harmonization applies

Clinical Trial Required

Local Testing Required

Yes

Gmp Required

Yes

Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ThailandNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Pending verification

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 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: thailand
China Classes In Scope: Class 2-4 devices and IVDs (detailed notification and licence routes); NMPA approvals do not qualify for the abridged pathway
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Abridged pathway requires at least one year of registration/approval history with a recognised agency (Big 5) per the Medical Device Control Division registration page
Full CSDT dossier still required; abridged omits duplicate technical evaluation only
Recognised-agency list formalised by FDA announcement B.E. 2567 (2024) on foreign agencies whose inspection or certification is accepted
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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)

ThailandUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · WHO

Prior approval / evidence record

Class 4

class-4

Class Name

Class 4

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 300
Max: 300
Unit: days

Verification Status

official-verified

Official Source

Title: Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
Url: https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 5
Unit: months

Prior Approval Benefits

FDA
EU CE Mark
Japan
TGA
Health Canada
WHO (for IVD)

Notes

Statutory cap: class-4 registration decided within 300 days (Ministerial Regulation B.E. 2563 ข้อ ๖)
Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file
Clinical evidence required

Clinical Trial Required

Yes

Local Testing Required

Yes

Gmp Required

Yes

Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Related structured datasets

Classification systems · 1 record

Open Risk classes 1 through 4. →

thailand:medical-device

Jurisdiction Id

thailand

Domains

medical-device
ivd

Name

Risk classes 1 through 4.

Classes

Id
1
Label
Class 1
Normalized Risk Level
low
Id
2
Label
Class 2
Normalized Risk Level
medium
Id
3
Label
Class 3
Normalized Risk Level
high
Id
4
Label
Class 4
Normalized Risk Level
highest

Regulator

Thai FDA

Official Domains

fda.moph.go.th

Source Status

official-source-verified

Source Title

Thai FDA — medical device registration (class/route table; MoPH notification on risk-based classification B.E. 2562)

Source Url

https://medical.fda.moph.go.th/product/category/about-product-registration

Verified On

2026-08-25

Source Supports

class-axis

Notes

Four risk classes per the MoPH notification on medical device classification by risk level B.E. 2562 (2019): class 1 lowest to class 4 highest.
Route by class: class 1 notification (จดแจ้ง); classes 2-3 detailed notification (แจ้งรายการละเอียด); class 4 licence (ขออนุญาต).

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Thailand registration →

Country

Thailand

Jurisdiction Id

thailand

Country Code

Flag

🇹🇭

Regulator

Thai Food and Drug Administration

Regulator Abbrev

Thai FDA

Region

asia-pacific

Tier

Risk Classification

4-class (1, 2, 3, 4)

Classes

Id
class-1
Class Name
Class 1
Risk Level
low
Pathway
Notification
Official Timeline
Min
200
Max
200
Unit
days
Verification Status
official-verified
Official Source
Title
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
Url
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
0
Max
2
Unit
months
Notes
Statutory cap: class-1 notification applications decided within 200 days (Ministerial Regulation B.E. 2563 ข้อ ๕)
Practical notification processing is typically much faster than the statutory cap
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-2
Class Name
Class 2
Risk Level
medium
Pathway
Registration
Official Timeline
Min
250
Max
250
Unit
days
Verification Status
official-verified
Official Source
Title
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
Url
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
4
Max
5
Unit
months
Prior Approval Benefits
FDA
EU CE Mark
Japan
TGA
Health Canada
WHO (for IVD)
Notes
Statutory cap: class-2 registration decided within 250 days (Ministerial Regulation B.E. 2563 ข้อ ๖)
Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file
ASEAN harmonization applies
Clinical Trial Required
No
Local Testing Required
Yes
Gmp Required
Yes
Id
class-3
Class Name
Class 3
Risk Level
high
Pathway
Registration
Official Timeline
Min
250
Max
250
Unit
days
Verification Status
official-verified
Official Source
Title
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
Url
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
4
Max
5
Unit
months
Prior Approval Benefits
FDA
EU CE Mark
Japan
TGA
Health Canada
WHO (for IVD)
Notes
Statutory cap: class-3 registration decided within 250 days (Ministerial Regulation B.E. 2563 ข้อ ๖)
Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file
Clinical data may be required
Clinical Trial Required
No
Local Testing Required
Yes
Gmp Required
Yes
Id
class-4
Class Name
Class 4
Risk Level
highest
Pathway
Full Registration
Official Timeline
Min
300
Max
300
Unit
days
Verification Status
official-verified
Official Source
Title
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
Url
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
4
Max
5
Unit
months
Prior Approval Benefits
FDA
EU CE Mark
Japan
TGA
Health Canada
WHO (for IVD)
Notes
Statutory cap: class-4 registration decided within 300 days (Ministerial Regulation B.E. 2563 ข้อ ๖)
Fee payment due within 60 days of the invoice; submission receipt issued within 7 days of a complete file
Clinical evidence required
Clinical Trial Required
Yes
Local Testing Required
Yes
Gmp Required
Yes

Expedited Pathways

Name
ASEAN Medical Device Directive (AMDD) harmonisation
Description
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.
Timeline Reduction
None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Eligibility
Any device filed in an ASEAN member state that has transposed the AMDD into national law

Prior Approvals

Authority
FDA 510(k)
Accepted
Yes
Benefit
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
Timeline Savings
None published
Authority
EU CE Mark
Accepted
Yes
Benefit
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Thai FDA publishes no shorter period for it
Timeline Savings
None published
Authority
ASEAN member-state registration
Accepted
No
Benefit
There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
Timeline Savings
None

Key Requirements

Thailand Local Agent
Thai labeling
Local testing from accredited labs
ISO 13485 certification
Free Sale Certificate

Local Rep Required

Yes

Mdsap Accepted

Mdsap Benefit

Not accepted but ISO 13485 required

Registration Validity

5 years

Verification Status

official-verified

Official Sources

Title
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
Url
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
Accessed Date
2026-08-25
Title
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"
Url
https://www.ahwp.info/sites/default/files/6%20Implementing%20the%20ASEAN%20Medical%20Device%20Directive%201.0.pdf
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Thai FDA. Appoint a local representative where required.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Thai FDA including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Thai FDA reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Thai FDA may issue questions.
Duration
200 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Thai FDA issues Thailand market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Thailand fees →

Country

Thailand

Jurisdiction Id

thailand

Country Code

Authority

TFDA

Low Risk Local

Min: 1800
Max: 3100
Currency: THB
Per Product: Yes

High Risk Local

Min: 36400
Max: 74000
Currency: THB
Per Product: Yes

Details

Id
class-1-application
Item
Class 1 - Application
Currency
THB
Amount Local
500
Amount Local Formatted
THB 500
Frequency
Per application
Notes
Same for local manufacture and import
Verification Status
official-verified
Source Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Source Title
Thai FDA manufacture/import fee table
Verified On
2026-08-25
Amount Status
exact-current
Id
class-1-document-verification-import
Item
Class 1 - Document Verification (Import)
Currency
THB
Amount Local
600
Amount Local Formatted
THB 600
Frequency
Per application
Notes
Local manufacture: THB 300
Verification Status
official-verified
Source Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Source Title
Thai FDA manufacture/import fee table
Verified On
2026-08-25
Amount Status
exact-current
Id
class-1-certificate-import
Item
Class 1 - Certificate (Import)
Currency
THB
Amount Local
2000
Amount Local Formatted
THB 2,000
Frequency
Per certificate
Notes
Local manufacture: THB 1,000; import total: THB 3,100
Verification Status
official-verified
Source Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Source Title
Thai FDA manufacture/import fee table
Verified On
2026-08-25
Amount Status
exact-current
Id
class-2-3-application
Item
Class 2/3 - Application
Currency
THB
Amount Local
1000
Amount Local Formatted
THB 1,000
Frequency
Per application
Notes
Same for local manufacture and import
Verification Status
official-verified
Source Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Source Title
Thai FDA manufacture/import fee table
Verified On
2026-08-25
Amount Status
exact-current
Id
class-2-3-expert-fee-import
Item
Class 2/3 - Expert Fee (Import)
Currency
THB
Amount Local
38000
Amount Local Formatted
THB 38,000
Frequency
Per application
Notes
Local manufacture: THB 30,400
Verification Status
official-verified
Source Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Source Title
Thai FDA manufacture/import fee table
Verified On
2026-08-25
Amount Status
exact-current
Id
class-2-3-certificate-import
Item
Class 2/3 - Certificate (Import)
Currency
THB
Amount Local
10000
Amount Local Formatted
THB 10,000
Frequency
Per certificate
Notes
Local manufacture: THB 5,000; import total: THB 49,000
Verification Status
official-verified
Source Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Source Title
Thai FDA manufacture/import fee table
Verified On
2026-08-25
Amount Status
exact-current
Id
class-4-application
Item
Class 4 - Application
Currency
THB
Amount Local
1000
Amount Local Formatted
THB 1,000
Frequency
Per application
Notes
Same for local manufacture and import
Verification Status
official-verified
Source Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Source Title
Thai FDA manufacture/import fee table
Verified On
2026-08-25
Amount Status
exact-current
Id
class-4-expert-fee-import
Item
Class 4 - Expert Fee (Import)
Currency
THB
Amount Local
53000
Amount Local Formatted
THB 53,000
Frequency
Per application
Notes
Local manufacture: THB 42,400
Verification Status
official-verified
Source Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Source Title
Thai FDA manufacture/import fee table
Verified On
2026-08-25
Amount Status
exact-current
Id
class-4-certificate-import
Item
Class 4 - Certificate (Import)
Currency
THB
Amount Local
20000
Amount Local Formatted
THB 20,000
Frequency
Per certificate
Notes
Local manufacture: THB 10,000; import total: THB 74,000
Verification Status
official-verified
Source Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Source Title
Thai FDA manufacture/import fee table
Verified On
2026-08-25
Amount Status
exact-current
Id
importer-establishment-registration
Item
Importer establishment registration - statutory certificate fee
Currency
THB
Amount Local
4000
Amount Local Formatted
THB 4,000
Frequency
Per certificate
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://medical.fda.moph.go.th/media.php?id=481145798093053952&name=กฎกระทรวง กำหนดค่าธรรมเนียมเกี่ยวกับเครื่องมือแพทย์ พ.ศ. 2563.pdf
Source Title
Thailand Ministerial Regulation on medical-device fees B.E. 2563 (2021), Royal Gazette
Source Effective Date
2021-03-17
Verified On
2026-08-25

Notes

Official table separates local manufacture and import fees
Class 1 import total: THB 3,100
Class 2/3 import total: THB 49,000
Class 4 import total: THB 74,000
Statutory certificate fees under the Ministerial Regulation on medical-device fees B.E. 2563 (Gazette 138/13ก, 15 February 2021, effective 30 days after publication): importer establishment registration THB 4,000; licence to import devices THB 20,000; licence to manufacture THB 10,000; detailed-notification receipts THB 10,000 (import) / THB 5,000 (manufacture); notification receipts THB 2,000 (import) / THB 1,000 (manufacture).
The Thai FDA importer-journey page shows route totals including assessment fees: THB 3,100 (establishment) and THB 49,000/74,000 (product registration by route), with a THB 4,000 certificate fee and THB 12,000 assessment fee.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Thai FDA manufacture/import fee table
Url
https://en.fda.moph.go.th/entrepreneurs-medical-devices/manufacture-import-commercialpurposes
Accessed Date
2026-08-25
Title
Thailand Ministerial Regulation on medical-device fees B.E. 2563 (2021), Royal Gazette
Url
https://medical.fda.moph.go.th/media.php?id=481145798093053952&name=กฎกระทรวง กำหนดค่าธรรมเนียมเกี่ยวกับเครื่องมือแพทย์ พ.ศ. 2563.pdf
Effective Date
2021-03-17
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Thailand certifications →

Slug

thailand

Market

Thailand

Confidence

low

Schemes

Id
thai-fda-electrical-emc-evidence
Name
Thai FDA electrical/EMC evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
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.
Source Urls
https://medical.fda.moph.go.th/customer-journey/%20newimporter
https://medical.fda.moph.go.th/ide-head/category/ide-02
Source Binding
reviewed
Id
nbtc-sdoc
Name
NBTC SDoC
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Eligible Radio Equipment
Source Urls
https://standard1.nbtc.go.th/
Source Binding
candidate
Id
nbtc-class-a
Name
NBTC Class A
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Eligible Radio Equipment
Source Urls
https://standard1.nbtc.go.th/
Source Binding
candidate
Id
nbtc-class-b
Name
NBTC Class B
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Eligible Radio Equipment
Source Urls
https://standard1.nbtc.go.th/
Source Binding
candidate
Id
tisi-compulsory-standards-mark
Name
TISI compulsory standards mark
Category
General Electrical Components
Status
Mandatory If Feature
Object
Listed Product Or Component
Source Binding
unresolved
Id
halal-certification
Name
Halal certification
Category
Halal And Material Origin
Status
Voluntary Or Procurement
Object
Eligible Product Or Claim
Source Binding
unresolved
Id
oap-radiation-generator-licence
Name
OAP radiation-generator licence
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Product And Use Site
Note
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.
Source Urls
https://www.oap.go.th/en/overview-of-office-of-atoms-for-peace
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
Source Binding
reviewed
Id
thai-fda-import-licensing
Name
Thai FDA import establishment licensing
Category
Import Conformity
Status
Mandatory At Import
Object
Commercial Importer
Note
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.
Source Urls
https://medical.fda.moph.go.th/customer-journey/%20newimporter
Source Binding
reviewed

Official Sources

Authority
NBTC
Topic
telecommunications equipment standards and SDoC/Class A/Class B
Url
https://standard1.nbtc.go.th/
Authority
Thai FDA
Topic
IDE clinical investigation standards ISO 14155 and ISO 20916
Url
https://medical.fda.moph.go.th/ide-head/category/ide-02
Authority
Office of Atoms for Peace
Topic
Nuclear Energy for Peace Act B.E. 2559 framework and OAP mandate
Url
https://www.oap.go.th/en/overview-of-office-of-atoms-for-peace
Authority
IAEA (GNSSN)
Topic
Thailand nuclear/radiation regulatory framework — OAP vs MOPH split for radiation generators, licence classes and validity
Url
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
Authority
Thai FDA (Medical Device Control Division)
Topic
New medical-device importer customer journey — import establishment registration before listing, Section 27 purpose categories
Url
https://medical.fda.moph.go.th/customer-journey/%20newimporter