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.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.