Medical Device and IVD Registration and Approval in Thailand

ANSWERED ON THIS PAGE:

• What is the medical device registration process in Thailand?
• How does Thailand classify medical devices and IVDs?
• Is an in-country representative required for foreign manufacturers?

Thailand’s medical device regulations

Medical devices and in vitro diagnostics (IVDs) are regulated by the Medical Device Control Division (MDCD) within the Thai Food and Drug Administration (FDA).

Thailand is in the process of aligning its national legislation with the Association of Southeast Asian Nations (ASEAN) Medical Device Directives (AMDD). As part of this transition, the Thai FDA published “Announcement of the Ministry of Public Health Re: Medical Device Classification According to Risk Level, B.E. 2562,” which implements a four-tier classification system according to device risk. Based on the risk classification, devices are required to obtain authorization in the form of registration, detailed notification or simple notification.

Emergo by UL has the expertise to help you navigate regulatory requirements and begin selling your device in Thailand.

Registration route in Thailand

The following provides a high-level overview of the general steps to regulatory compliance for medical devices and IVDs of all classes in Thailand:

1. Appoint an in-country representative registered with the Thai FDA.
2. Submit product information to MDCD for class verification (optional).
3. Submit the required documents to the MDCD. Documentation requirements differ by device class.
4. If accepted, the MDCD will approve the application.
5. Payment of fees.
6. Issuance of notification/registration.
7. Begin marketing.

Medical device classification in Thailand

Thailand has adopted the ASEAN risk-based classification of medical devices. According to the “Announcement of the Ministry of Public Health Re: Medical Device Classification According to Risk Level, B.E. 2562,” medical devices and IVDs shall be classified according to the degree of risk given below:

• Class 1 – low risk
• Class 2 – low to moderate risk
• Class 3 – moderate to high risk
• Class 4 – high risk

The rules for classifying medical device and IVD risks depend on the device’s nature and intended use. For medical devices, this means accounting for the level of invasiveness into the body, duration of use, characteristics of usage and the biological effect. For IVDs, this means accounting for the user's expertise, the data's importance, and the impact of the data gained from the device for individual and public health.

Let Emergo assist you with Thailand’s regulatory approval process

Emergo is an international consulting firm that works exclusively for medical device and IVD companies. Our experienced team is equipped to assist with the Thailand registration process. Here's how we can help:

• We can assist you in properly classifying your device to streamline the registration process.
• Emergo can compile the necessary documentation for the registration application to the Thai FDA.
• Our experienced consultants can help you update your existing quality system to meet ISO 13485 QMS requirements.

With offices in the Middle East, Europe, North America and beyond, Emergo can help you start selling in Thailand and markets around the world. Please contact us for more information about our medical device and IVD registration services for Thailand.

Frequently asked questions about Thailand

Do I need an in-country representative?

Foreign manufacturers must appoint an in-country representative to submit the registration application on their behalf. This entity must hold an establishment license. A distributor or other party can fill this role.

Emergo does not provide in-country representative services in Thailand at this time but can provide contact details for a qualified firm, if interested.

Does Thailand need Country of Origin approval to be eligible for registration in Thailand?

Neither the Medical Device Act B.E. 2551 (A.D. 2008) nor the Medical Device Act (2nd Edition) B.E. 2562 (A.D. 2019) discuss home country approval. However, documentation of registration history is required for Class 1 devices, and proof of authorization from other competent authorities is required for registering Class 2 to 4 devices.

Some high-risk devices may be eligible for an expedited registration process if they are registered in Singapore by the Health Sciences Authority (HSA).

Emergo can advise further if your product is eligible to be registered.