• 2022-04-27 10:59:13

On March 25th, 2022, Qualtech held an online seminar to introduce Japanese health authorities' requirements on technical data, which can be submitted during PMDA/RCB's approval process.

• 2022-01-26 08:31:11

Clinical trial data is one of the important supporting documents for evaluating the safety and effectiveness of medical devices. Standardizing the collection, sorting, analysis, and submission of medical device clinical trial data will not only improve the quality of clinical trial implementation and management but also assist the regulatory agency to understand and review the development of clinical trials quickly and efficiently.

• 2021-01-19 02:38:54

NMPA's newly released Guiding Principles explain the general, principled and forward-looking requirements for the application of real-world data of medical devices in clinical evaluation.

• 2020-12-23 02:21:33

MDA has announced a new search database, Medical Device Authority Register (MDAR).