• 2024-09-17 05:40:30

NMPA issued a notice that administrative paperwork for some registration matters will become electronic versions starting June 1, 2024.

• 2022-10-25 07:24:41

Requirements for pre-assessment of medical device / in vitro diagnostic medical device registration are revised by NMPA.

• 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.

• 2021-08-26 12:02:05

In light of the latest COVID-19 situation in Malaysia, MDA has published a guidance document on medical face masks and respirators. The MDA/GD/0033 explains the minimum requirements for labeling as well as the performance characteristics of face masks and respirators that need to fulfill.

• 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.

• 2021-02-19 09:51:48

Asia’s elderly population is set to see tremendous growth, coupled with a rise in various geriatric and non-communicable health issues. To tackle these problems, rehabilitative and assistive medical devices market show great potential to become a major medical device segment in various Asia countries. In this issue of QT Analysis, we look at the market size for rehabilitative and assistive medical device and their registration requirements in some major Asian countries.