The "Good Criteria and Practice for Importing and Selling of Medical Devices 2023," published in the Royal Gazette on January 5, 2024, represents a significant leap forward in Thailand's regulation of medical devices. This comprehensive framework outlines key components aimed at enhancing safety, quality, and oversight in the import and sale of medical devices. In this article, we delve into the core aspects of the regulation, its enforcement timeline, and its implications for manufacturers, importers, and distributors in Thailand.

Key Components:

The framework is structured into four essential sections, each addressing critical aspects of the import and sale of medical devices:

  • Section 1: Organization, Management System, and Determination of Duties and Responsibilities
  • Section 2: Resource Management
  • Section 3: Supply Chain and Device Specifications
  • Section 4: Monitoring and Surveillance

    Timeline of Enforcement:

The enforcement timeline outlined in the regulation is designed to allow establishments adequate time to adapt to the new requirements while ensuring timely compliance:

January 5, 2025

Section 2 and Section 3

New Establishments

January 5, 2026

Section 2 and Section 3

Old Establishments

January 1, 2027

Section 2, Section 3, and Section 4

New Establishments

Old Establishments

January 1, 2029

Section 1, Section 2, Section 3, and Section 4

New Establishments

Old Establishments

  • New Establishments: Entities that registered as establishments for importing and selling medical devices after January 5, 2025.
  • Old Establishments: Entities registered before January 5, 2025.

    Responsibilities of Importers:

Importers, as applicants in Thailand, bear the primary responsibility for ensuring compliance with the regulation within the specified timelines. This includes implementing the necessary measures to adhere to all four sections of the framework and ensuring that appointed distributors are capable of meeting regulatory requirements.

Responsibilities of Product Owners:

Product owners are obligated to acknowledge the regulatory framework and collaborate with local importers and distributors who comply with the requirements outlined in the announcement.


The "Good Criteria and Practice for Importing and Selling of Medical Devices 2023" signals a new era of regulation in Thailand's medical device industry. Stakeholders must adhere to these standards for safety and quality, ensuring smooth compliance and effective enforcement.

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Notification of the Ministry of Public Health: the quality system for importing or selling medical devices B.E. 2566 (2023)

Thai FDA GDP Notification