Third 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.
We have previously looked at the broad outlines of the 2021 Regulation, before detailing the provisions on clinical evaluation and clinical trials.
In this newsletter we will focus on the new registration system for Medical Devices (“MD”).
The introduction of the MD Registrant System in China is one of the key point of the 2021 Regulation. This corresponds to the concept of “marketing authorization holder” for pharmaceuticals.
What is the MD Registrant System? How does it work? What are the impacts of this new system for MD supervisions?
The series
On New Medical Device Regulations in China
