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Thailand Medical Device Regulatory Authority

Thai Food and Drug Administration (TFDA) is responsible for the regulation and approval of all medical devices sold in the Thai market to ensure their safety, effectiveness and quality. The responsibilities of the department include:

① Approval of medical device registration applications

② Develop and enforce relevant regulations and standards;

③ Supervise the market circulation and use of medical devices, and carry out necessary supervision and inspection.

Address: Food and Drug Administration, Ministry of Public Health 88/24 Tiwanon Road, Mueang District, Nonthaburi11000 THAILAND

Open: Monday-Friday 08.30-16.30 hrs.

Regulatory Authority Official Website: ：https://en.fda.moph.go.th/

Database Link: https://www.fda.moph.go.th/?op=kwssl&lang=1&skin=s&db=Main&ww=

Administrative Regulation

Medical Devices Act, B.E.2551 (2008) and (No. 2), B.E. 2562 (2019)

ASEAN Medical Device Directive（AMDD）

Classification of Risk Level

The risk classification of medical devices in Thailand strictly follows Appendix 3 of the ASEAN Medical Device Directive (AMDD). In accordance with the Thai regulation Risk Classification of Medical Devices, B.E. 2562 (2019), medical devices are categorized into two main types: general medical devices (Non-IVD) and in vitro diagnostic (IVD) devices. Both categories are further divided into four risk levels from low to high: Class 1, Class 2, Class 3, and Class 4.

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Entry requirements

A valid ISO 13485 Quality Management System certificate is required.

Registration Language

For Professional Use: English

For Non-Professional Use: Labels and Instructions for Use (IFU) must be provided in both English and Thai; other documentation may be submitted in English only-4.

Registration Pathways, Process, and Official Fees

1.Registration Pathways

https://en.fda.moph.go.th/entrepreneurs-medical-devices/%20manufacture-import-commercialpurposes

① Full Evaluation Pathway

Applicable to medical devices with no prior registration history in any reference country.

② Abridged Pathway

Applicable to medical devices of Class 2 – Class 4. The product must have obtained registration certification (full evaluation) from any one of the following six reference regulatory agencies for at least one year, with no serious adverse events reported:

European Union (EU NB), Canada (HC), Japan (MHLW), Australia (TGA), United States (FDA), or the World Health Organization (WHO).

③ Reliance Program

Applicable to medical devices of Class 2 – Class 4. The product must have obtained approval from Singapore Health Sciences Authority (HSA).

2. Registration Flow

3. Registration Cycle | Official Fee

https://en.fda.moph.go.th/entrepreneurs-medical-devices/%20manufacture-import-commercialpurposes

FAQ

Q: Do Class 1 medical devices require a QMS certificate for TFDA registration?

A: Yes, it requires ISO 13485 certificate.

Q: What country registration certificates can expedite the audit of TFDA application?

A: If you have the following 6 certificates, you can be expedited when applying for TFDA registration in Thailand:

①【European Union】European Union Notified Bodies:EU NB

②【Canada】Health Canada HC

③【Japan】Japan Ministry of Health Labour and Welfare:MHLW

④【Australia】Therapeutic Goods Administration:TGA

⑤【America】US Food and Drug Administration:US FDA

⑥【WHO】WHO Prequalification of in Vitro Diagnostics(IVD)（仅IVD）

Q: Does Thailand import require a certificate holder to clear customs?

A: Yes. According to the requirements of Thai regulations, the holder is the importer, and the clearance of goods from Thailand customs must be completed by the holder in the customs system. According to the actual operating experience of Wiselink Thailand subsidiary, the reference process is as follows:

Q: If a manufacturer wants to establish a company in Thailand, is it acceptable to become a license holder?

A: Yes, to become a medical device holder in Thailand, in addition to registering a Thai company, it is also necessary to obtain a medical device import license issued by TFDA, and it is necessary to have an independent warehouse in Thailand that has been approved by TFDA. Wiselink Thailand subsidiary can assist manufacturers to complete the establishment of Thai companies, apply for medical device import qualification, provide warehouse that can pass TFDA audit, financial and tax compliance and other services.

四、Certification Template of TFDA registration

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