Access to the IVD market in China is lengthy and complicated.
In many cases, establishments are removed due to a failure to renew annual registration with the agency.
Get to know the local government, including the available benefits and incentives first.
FDA owns the sandbox, so play by the rules!
Consider taking a multi-pronged approach to this complex landscape.
In lieu of trials, some companies may be able to submit a CER.
The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations.