Original title: Our province fully implements the "Regulations on Medical Device Supervision and Administration" On June 16, the Provincial Food and Drug Administration held a press conference to fully implement the new revision of the Medical Device Supervision and Administration Regulations (hereinafter referred to as "Regulations" on our province. ) The relevant situation has been introduced. The "Regulations" fully reflect new, excellent, all, strict characteristics, guarantee the quality and safety of medical equipment, promote the development of the industry according to law, promote scientific supervision capacity building, and ensure the "research" of medical equipment, "production" safe, " "Strict," use "to rest assured, and effectively guard the safety of mass use.
The new revision of the Medical Device Supervision and Administration Regulations began to implement this year, focusing on the revision of the four aspects: implementing the reform requirements of the medical device trial examination and approval system, further consolidating the entity of enterprises; consolidating the "venting service" reform results, Optimize the approval of the filing procedures, implement priority to innovative medical equipment, release market innovation, further mitigate enterprise burden; strengthen the supervision of the full life cycle and whole process of medical equipment, improve supervision efficiency; increase the punishment of illegal acts, improve illegal cost.
Next, the Provincial Food and Drug Administration will innovate publicity form and means, strengthen the training of law enforcement officers and enterprises; adhere to the fact that the safety of epidemic prevention materials; adhere to risk management, improve the construction of adverse event monitoring system, build medical Equipment risk prevention and control, solid defense, persistence, promote local governments, regulatory authorities, enterprises, etc. "Three Services", support key enterprises, support industrial parks, help large logistics companies to make great strength, promote high quality development of medical equipment industry.
(Reporter Meng Ting).