Second newsletter of our series dedicated to Medical Devices Regulation in China further to the promulgation of the Regulations on Supervision and Administration of Medical Devices, which entered into force on June 1st, 2021.
In this newsletter we will take a closer look at clinical evaluation and clinical trials.
The 2021 Regulations encourages, through different measures, innovation and development of the medical device industry, Chinese regulators intending to maintain the delicate balance between safety and innovation in this area. The rules related to clinical evaluation and clinical trial for medical devices are in this framework.
The series
On New Medical Device Regulations in China