New Thai FDA Regulation Tightens Controls on Medical Device Import: Impact on “Smart” Importers
On June 21, 2024, the Thai Food and Drug Administration (FDA) introduced a groundbreaking regulation that reshapes the landscape for medical device import in Thailand. This regulation mandates stricter qualifications and responsibilities for the appointed “responsible person” in companies involved in the manufacturing, importing, and selling of medical devices.
New Requirements for the Responsible Person for Medical Device Import
Under the new regulation, every company involved in the medical device sector must appoint a responsible person who meets specific criteria based on their role:
- Medical Device Production Supervisor
- Qualifications: Must hold at least a bachelor’s degree in Science, Pharmacy, Medicine, Engineering, Medical Technology, Veterinary Medicine, or another related scientific field. Additionally, they must have at least one year of experience managing a quality system for medical devices.
- Responsibilities: Ensure compliance with quality systems during production, verify that each production batch meets legal standards, and confirm that labels and documents are accurate and not misleading.
- Medical Device Import Supervisor
- Qualifications: Must hold at least a bachelor’s degree and reside in Thailand.
- Responsibilities: Oversee and ensure that the import and sale of medical devices follow the quality system, and ensure that labels and accompanying documents are accurate and compliant with the law.
- Medical Device Sales Supervisor
- Qualifications: Must hold at least a bachelor’s degree and reside in Thailand.
- Responsibilities: Oversee and ensure that sales comply with the quality system and the relevant legal criteria, methods, and conditions.
Additional Key Points
- Residency Requirement: The responsible person must reside in Thailand, ensuring that they are present and accountable.
- Foreign Nationals: Can be appointed as the responsible person if they have a valid work permit and meet the specified qualifications.
- Transition Period: Companies with existing licenses must update them to include a responsible person within one year from the announcement date (June 21, 2024).
- Public Display: The name of the responsible person must be displayed on a signboard at the establishment.
Impact on Small and Semi-Fake Importers
This new rule signals a decisive move by the Thai FDA to crack down on small and semi-fake importers who have exploited loopholes in the previous system. These “smart” companies often used random individuals or, in some cases, merely borrowed the ID of a Thai citizen to secure a permit at a low cost. As a result, many import companies listed Isaan farmers, grandmothers, or other unqualified individuals as their responsible person, undermining the integrity of the medical device market.
With the new regulation, such practices will become virtually impossible. The requirement for a qualified and present responsible person, along with the stipulation that foreign nationals in this role must hold a valid work permit, raises the bar significantly. Companies can no longer rely on “phantom” representatives to satisfy regulatory demands.
Medical Device Import Good Distribution Practice: A Complementary Move
This regulation aligns with the Thai FDA’s broader project to implement Good Distribution Practices (GDP) for medical devices, further tightening control over the sector. The GDP regulation, as detailed in our recent article [link: https://www.siamdevelopment.com/tfda-medical-device-gdp-thailand-issues-new-regulation-for-good-distribution-practices/], ensures that medical devices are stored, handled, and distributed under stringent conditions, reinforcing the importance of quality and safety at every step of the supply chain.
Conclusion
The introduction of these new requirements marks a significant step towards enhancing the quality and safety of medical devices in Thailand. It sends a clear message that the days of circumventing the law through loopholes are over. By wiping out small and semi-fake importers, the Thai FDA is setting a new standard that will benefit consumers and legitimate businesses alike. The integration of these measures with the ongoing GDP initiative further solidifies Thailand’s commitment to upholding the highest standards in the medical device industry.
