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.
Conclusion:
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.
Work With Us!
Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.
Contact us today here to unlock your medical device potential.
References: