China Ready For More Medtech Market Access Simplifications
Executive Summary
Following the recent news of local trial exemptions for almost 160 types of medical devices and IVDs in China, the China Food and Drug Administration is preparing to introduce more market access regulatory simplifications for medtech companies entering the Chinese market.
You may also be interested in...
China Proposes Local Trial Exemptions For Another 130 IVDs, 27 Devices
China has proposed expanding its list of IVDs and medical devices that are exempted from the requirement to undergo local clinical trials. The proposal, when finalized, may speed up the registration of affected products by several months. With respect to ongoing trials, manufacturers will have to decide whether they want to continue with these.
Third Expedited Approval Pathway Coming To China In January
China Food and Drug Administration is introducing a new priority-review designation pathway that many companies are expected to use, although it is not yet clear just how much time it will save compared with the standard approval process.
The Sustainability Stakes Are Rising: ‘We Cannot Recycle Our Way Out Of This’
The journey to Net Zero, described as ‘the defining issue of our time,’ will get harder in the coming decade. Failure to keep up the pressure will result in more long-term health conditions, increasing deaths and higher costs. The UK NHS is a Net Zero exemplar globally, but without a systemic approach, its compliance efforts could stutter.