Thai Food and Drug Administration (Thai FDA)

1. Overview

The Thai Food and Drug Administration (Thai FDA) is responsible for safeguarding the well-being of consumers, particularly by guaranteeing the safety, quality, and effectiveness of various health products under its jurisdiction. Important matters are determined by committees comprised of experts in their respective domains, appointed by the Minister of Public Health. Presently, there are six committees focusing on Drugs, Medical Devices, Food, Cosmetics, Narcotics, and Psychotropic Substances.

2. Thai FDA medical device registration

 The oversight of Thailand’s medical device regulations falls under the jurisdiction of the Medical Device Control Division (MDCD) within the Thai FDA.

Thailand employs a four-tiered risk-based classification system (Class 1-4) and strictly follows the recommendations of the ASEAN Medical Device Directive (MDD). The classification determines the applicable registration process to obtain an import license. Class 1 products require listing, Class 2 and Class 3 products need notification, and Class 4 products, posing the highest risk, require licensing. Factors influencing risk classification include the intended use and indications, the user’s level of expertise, and the overall impact and significance of the device’s information to individuals and public health.

In general, applications for Class 2-4 products must adhere to the Common Submission Dossier Template (CSDT) format for Conformity Assessments under the new regulations, while Class 1 Listed products require less documentation.

The license holder must hold an establishment license issued by the Thai FDA. At present, only individuals holding Thai nationality or locally established companies in Thailand are eligible to apply for an Establishment License.

The approval of the complete registration process may span 3-9 months if all requirements are met. Upon approval, Thailand medical device registration licenses are valid for five years.

3. Thai FDA drug registration

 Foreign pharmaceutical companies seeking drug product registration in Thailand must designate a local representative or engage a company based in Thailand to serve as their legal representative. This representative plays a crucial role in liaising with the Thai Food and Drug Administration (TFDA). In essence, the local representative takes on the responsibility of facilitating communication with the TFDA and ensuring regulatory compliance on behalf of the foreign pharmaceutical company.

Pharmaceutical products in Thailand are grouped into three categories based on their risk levels and intended usage.

1. Over-the-Counter (OTC) Drugs: these are non-prescription medications designed for self-treatment
2. Prescription Drugs: require a doctor’s prescription because these medications carry higher risks due to potential side effects.
3. Traditional and Complementary Medicines: This category includes traditional Thai herbal medicines

Before initiating the registration process, foreign companies must provide pre-registration documents. These include a letter designating a local representative, a product sample, and a certification letter affirming adherence to Good Manufacturing Practice (GMP) standards.

The registration process is outlined below:

1. Document Submission: Companies are required to submit documentation including product details, quality and clinical trial data, and labeling information.
2. Review and Evaluation: the TFDA evaluates the submitted documents, scrutinizing their completeness and adherence to regulatory standards.
3. Inspection: an inspection of the manufacturing facility may be conducted to verify compliance with GMP standards.
4. Approval: Upon satisfaction with the application, the TFDA grants approval for marketing the product in Thailand.

The timeframe to register pharmaceutical products in Thailand varies depending on the complexity of the product and the completeness of documentation, usually ranging from 6 months to an average of 2 years.