Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea
An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
New Search
If you are not happy with the results below please do another search
39 search results for:
How New EU MDR Requirements Will Affect Registrations in Asia
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
Medical Device Advertising Requirements in Asia
In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
China Releases Draft Clinical Evaluation Exemption List for 2022
On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.
China Publishes 9 Draft Guidelines for Registration of Medical Devices
Recently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June.
NMPA Issues New Guidance for Medical Device Software in China
In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.
China Fully Implements UDI Requirements for Class 3 Medical Devices
Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.
China Issues Recommendation for Medical Device Clinical Data
For medical device registration in China, one of the most important documents to be provided is clinical data.
China to Implement New Electrical Safety Standards for Medical Devices
An updated China-specific electromedical safety standard (BG 9706.1-2020) that was announced back in February of 2020 will come into full effect on May 1, 2023.
China to Require All Electromedical Devices Meet Updated Standards
This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.