Chapter 1 Thai TFDA

1. Thailand Medical Device Administration

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 Health88/24 Tiwanon Road, Mueang District, Nonthaburi   11000THAILAND

Open:Monday-Friday 08.30-16.30 hrs.

Web：https://en.fda.moph.go.th/

2. Administrative Regulation

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

ASEAN Medical Device Directive

3. Classification of Risk Level

Thailand's medical device risk classification strictly complies with Appendix 3 of the ASEAN Medical Device Directive AMDD. According to Thai regulations, RISK CLASSIFICATION OF MEDICAL DEVICES, Β, E.2562 (2019) Medical devices (Non-IVD) and in vitro diagnostic reagents (IVD) are divided into two categories: 

Medical devices (Non-IVD) are classified into four categories from low to high risk: Class 1, Class 2, Class 3, and Class 4

In vitro diagnostics (IVD) are divided into four categories from low to high risk: Class 1, Class 2, Class 3, and Class 4

4. Entry requirements

ISO 13485 certificate.

5. Registration Language

[For professional use]: English

[For non-professionals]: Labels, instructions, available in English and Thai; Other information except labels and instructions can be provided in English.

Chapter 2 Registration Approaches| Flow | Cycle | Official Fee

1. Registration Approaches

①Full evaluation process approval approach

Allows no registration history in any country.

②Reliance program simplifies the audit approach

Approach conditions: Applicable to medical devices with risk levels of Class 2 to Class 4;

The medical device must be registered and certified (through comprehensive evaluation) in one of the six reference regulatory bodies of the European Union (EU NB), Canada (HC), Japan (MHLW), Australia (TGA), the United States (FDA), and WHO, and be on the market for more than one year without any serious adverse events.

③Concise pathway dependency audit approach

The approach conditions are applicable to medical devices with risk Class 2 to Class 4.

Medical devices must be approved in Singapore (HSA);

2. Registration Flow

3. Registration Cycle | Official Fee

Chapter 3 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.

Chapter 4 Certification Template of TFDA registration