On March 4, an official from the State Food and Drug Administration stated at a symposium between representatives of the two sessions of the pharmaceutical industry that this year, the documents, regulations, and regulations regarding medical devices will be comprehensively revised. Industry insiders said that the State Council executive meeting in February had just reviewed and approved the "Regulations on the Supervision and Administration of Medical Devices (Revision Draft)" (hereinafter referred to as the "Draft"), and these amendments should be carried out around this "Draft."

On February 12, Premier Li Keqiang reviewed and approved the above-mentioned "Draft" at an executive meeting. This "late" amendment regulation will be officially introduced after 7 years. According to industry insiders, classified management and encouraging innovation are the two main lines of the draft, which have been reflected in the relevant policies previously released, but the specific rules need to be improved.

Since 2013, CFDA has successively promulgated "Medical Device Classification Rules" (Revised Draft), "Special Approval Procedures for Innovative Medical Devices (Trial)", "Medical Device Operation Quality Management Standards (Draft for Comment)" and 104 medical device industries Standards, the supervision of medical devices has achieved full coverage from registration, innovation review, production, and distribution operations.