China Renews List of Devices Exempt From Clinical Trials
This article was originally published in Clinica
Executive Summary
China's Food and Drug Administration is inviting feedback on a new batch of medium- and high-risk medical devices that it intends to exempt from having to undergo local clinical trials. The agency's proposal, if adopted, would make it much easier and less costly for companies that want to place these devices on the Chinese market.
You may also be interested in...
China Confirms Second Batch Of Device Clinical Trial Exemptions
Chinese regulators have added another 359 medical devices to the list of those not needing to undergo clinical investigation in China following feedback from the industry. This second batch of exemptions follows the initial list issued at the end of 2014.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.