• 2024-12-16 05:25:54

The FDA has introduced the Safety and Performance-Based Pathway, offering an alternative route for device clearance by focusing on performance criteria rather than direct comparison to a predicate device. This approach simplifies submissions by emphasizing established safety and performance standards, ensuring effectiveness while reducing regulatory complexities.

• 2024-07-30 02:55:19

Thailand's Ministry of Public Health is enforcing stricter rules for dental devices. Specific dental products like implants and orthodontic instruments can only be sold to certified dentists and approved healthcare providers. Distributors must have selling approval certificates for transparent distribution. These changes aim to enhance patient safety and raise dental care standards, requiring quick adaptation from stakeholders.

• 2022-12-27 07:16:43

On November 2nd, Japan's Ministry of Health, Labor and Welfare announced an amendment in the Approval Criteria for dental implants.

• 2021-04-26 03:19:54

Asia Pacific forms one of the most promising dental device markets in the world. In this edition of QT Analysis, we look into the market size waiting for you to take advantage of and the requirements to register your dental devices in this region.