Many considerations should not be overlooked.
Throughout 2018, device and diagnostic manufacturers have opportunities to address challenging market trends and turn internal change into ways of increasing business and goodwill from providers who purchase their technology.
Get to know the local government, including the available benefits and incentives first.
The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
The agency is seeking more participation among different genders, ages, races and ethnic groups.
Companies must be aware of the changing clinical trial regulatory environment for devices in China.
The agency’s latest draft guidance is part of its strategy in creating a national evaluation system for medical devices.
Choosing the right CRO has a big impact on product registration and time to market.
In lieu of trials, some companies may be able to submit a CER.
As the agency continues to try to do more with fewer resources, taking additional risks is imperative to move forward.