Compared with Regulations on Supervision and Administration of Medical Devices (2017 Amendment) (the “2017 Edition of the Regulations”), the New Regulations pay more attention to promoting the innovative development of the medical device industry, and simultaneously focus on the quality and safety of medical device products. This article will interpret the main contents and the highlights of the amendment of the New Regulations, and analyze the changes in China’s medical device regulatory system under the New Regulations and its impact on the industry development.
Continue Reading Optimizing Supervision System and Promoting Industrial Development – Interpretation of Key Points of Regulations on Supervision and Administration of Medical Devices (2021 Amendment)
Supervision and Administration of Medical Devices
China’s Revised Regulations on the Supervision and Administration of Medical Devices: New Supervisory System and Increased Penalties
By King & Wood Mallesons on
Posted in Healthcare
By kingandwood Mallesons’ Healthcare Group
On 31 March 2014, Chinese government released the revised Regulations on the Supervision and Administration of Medical Devices (“Revised Regulations”). The Revised Regulations will come into effective on 1 June 2014, presenting following major changes:
Classification and Supervision System Adjustment
According to the Revised Regulations, medical devices are still supervised and managed under a Class I, Class II and Class III system based on the risk to the users. However, the supervisory system has been changed with below highlights.
Continue Reading China’s Revised Regulations on the Supervision and Administration of Medical Devices: New Supervisory System and Increased Penalties