The State Drug Administration has released a new version of the "Regulations on Quality Management of Medical Device Production", which will be implemented from November 1, 2026.

According to the State Drug Administration on November 4, on November 4, the State Drug Administration released a new version of the "Regulations for the Quality Management of Medical Device Production". The new version of the "Regulations" will be implemented from November 1, 2026. The new version of the "Regulations" is a revised version based on the 2014 version, and is an important measure for the State Drug Administration to implement the Opinions of the General Office of the State Council on comprehensively deepening the reform of drug and medical device regulation to promote the high-quality development of the pharmaceutical industry and relevant regulations. It comprehensively strengthens the construction of the quality management system of medical device enterprises and promotes the overall improvement of the quality management level of China's medical device industry.