Medical Device Regulation: Key Updates from Thai FDA

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The Thai Food and Drug Administration (FDA) has introduced a new initiative to enhance business operations through the use of electronic systems. Effective May 1, 2024, the FDA will discontinue the requirement for business operators to submit physical copies of their ID cards, house registrations, or corporate certificates when applying for health product approvals. This initiative aims to streamline processes, saving time and reducing costs for businesses.

Aligned with the government’s digital policy, this initiative fosters collaboration among various governmental agencies to facilitate seamless data sharing. The FDA’s official announcement revokes the necessity for three types of documents, which can now be accessed electronically through the Department of Provincial Administration and the Department of Business Development (DBD). These documents include copies of the ID card, house registration, and corporate certificate.

To support this transition, the FDA has updated over 100 citizen service manuals in accordance with the Facilitation Act of 2015. Additionally, the E-submission system, covering 379 procedures, has been improved to accommodate this new process. As one of the ten pilot agencies in this initiative, the FDA collaborates with the DBD and the Office of the Public Sector Development Commission to enhance service levels and integrate corporate data across various agencies, thereby easing the documentation burden on businesses.

Practical Implications of the New Procedure:

While this initiative represents a step towards streamlining bureaucratic processes, its practical impact may be limited. Since 2018, the application for health product registration, including food, has been entirely online under the operator’s ID card number. Therefore, this simplification primarily affects the initial application of a company as an importer or manufacturer of health products.

New Guidance for License Exemptions on Medical Devices in Thailand

The Ministry of Public Health (MOPH) and the Thai FDA have issued several notifications to support and promote the research and development of medical devices. These notifications offer additional guidance for manufacturers and importers of specific medical devices seeking exemptions from licensing requirements under the Medical Device Act.

Key Updates:

Clinical Research Exemptions:

Manufacturers or importers of medical devices intended for human clinical research must now obtain a letter of approval from an FDA-approved Human Research Ethics Committee (HREC) to apply for licensing exemptions.

The FDA has provided guidelines outlining the criteria, methods, and conditions for approving HRECs to oversee clinical research involving medical devices.

Personal Use Import Exemptions:

The FDA has established new criteria for importing medical devices for personal use, exempting importers from providing a certification letter from a healthcare professional as part of the licensing exemption process.

The notification specifies the types and quantities of medical devices eligible for these exemptions under various importation scenarios.

These updates aim to streamline processes, reduce regulatory burdens, and encourage innovation in the Thai medical device sector.

Practical Implications of the New Procedure:

These exemptions are expected to facilitate clinical research in Thailand and ease the importation process for individuals in need of devices for personal treatment. While simplifying, it’s important to note that these exemptions do not introduce entirely new processes but rather streamline existing ones. Samples and devices for personal use were already authorized for importation, albeit through slightly more complex procedures.

Silk Legal provides a range of services for several practice areas. This article is for information only, and while we have tried to keep our updates as accurate as possible, there may be changes to legislation or other factors that can affect your decisions. Please feel free to contact us for a free consultation at [email protected].

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