In a move to bolster safety standards, Thailand's Ministry of Public Health has announced a significant update to its dental medical device regulations. With the enforcement of a pivotal announcement—namely, "Criteria, Methods, and Conditions in Selling Dental Medical Devices, 2024"—the nation's dental healthcare landscape is poised for a transformative shift.
Enhanced Criteria for Selling Dental Medical Devices
From June 27, 2024, specific dental products can only be sold to authorized dental facilities, certified dentists, or those holding valid selling approval certificates.
Specified Dental Products Subject to Restriction
- Dental Implants
- Orthodontic Instruments: Including brackets, braces, elastics, wires, and bands.
- Clear Dental Aligners
- Dental Filling and Restoration Instruments: Such as etching materials, filling materials, bonding agents, or cementing agents (excluding denture glue).
- Artificial Teeth Instruments: Including impression materials and artificial teeth.
- Fluoride Varnish
Distributors must obtain a selling approval certificate before offering these items. This ensures a transparent and accountable distribution network, ultimately benefiting patients.
Responsibilities of Importers and Product Owners
- Importers: As the parties responsible for application and importation, importers bear the primary obligation to ensure adherence to these regulations within the designated timeframes. This encompasses confirming that selected distributors are capable of fulfilling these criteria.
- Product Owners: As those involved in the dental field wrestle with these significant adjustments, there's an urgent requirement for proactive adjustment and adherence. Becoming well-acquainted with the revised regulations and ensuring strict compliance with the outlined guidelines will be essential for navigating this altered regulatory environment.
Conclusion:
These regulatory changes demonstrate Thailand's commitment to prioritizing patient safety and promoting excellence in dental care. By working together and adhering to these regulations, all stakeholders can contribute to the advancement of dental services in Thailand, ultimately benefiting both practitioners and patients. Staying up-to-date with the evolving regulatory framework is crucial. We strongly advise consulting official sources and seeking assistance from certified experts to guarantee complete adherence to the revised regulations.
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.
Connect with us today here to unlock your medical device potential.