Director CFDA: For the medical doctors who have problems, they should concentrate their efforts on rectification, carry out the flying inspection and high-pressured blows

Medical Network January 19 hearing of the State Food and Drug Administration Medical Devices Regulatory Division Party branch secretary, director Kong Fanpu recently wrote the article pointed out that after the 19th National Congress, medical equipment supervision to do the 'eight' key work, which the medical device industry, business , And even practitioners, will have an impact.

First, continue to improve the regulatory law after the listing of medical devices Regulations System, promote medical equipment regulatory legislation, the core content into the "drug Management Law "revised the scope of the medical device monitoring for the legal hierarchy rose to increase the crackdown on illegal medical devices behavior.

The second is to improve the licensing system for medical device companies directly reporting adverse event system and re-evaluation system, revision of "medical device monitoring and re-evaluation of adverse event management approach" to implement enterprise The main responsibility.

The third is the implementation of the whole process of medical device inspection responsibilities, a reasonable division of regulatory powers of medical devices, the implementation of local regulatory responsibilities at all levels to eliminate regulatory risk blind spots to promote illegal punishment to others, the results of the inspection and punishment to the public.

Fourth, we will promote the construction of a professional team of medical device inspectors, implement a system of examiners at different levels, strengthen inspector training, strengthen inspection equipment and equipment, and build a high-quality inspection team with international inspection capability.

Fifthly, in response to public concerns and social concerns, we searched for potential risks and continued to focus on the rectification of products that are heavily used, highly concerned and highly risky by the public. We continued to carry out flight inspections, intensified the crackdown and maintained a high-pressure posture.

Sixth, we will continue to organize overseas inspections and strengthen the import of medical devices proxy People supervision and management, and strive to achieve the import medical instruments Quality supervision of the entire process.

Seventhly, we will strengthen the construction of informatization of regulation and give full play to the role of big data in risk analysis and risk prevention and control, strengthen the construction of regulatory information networks and databases, and achieve interconnection and interworking and enhancement of regulatory efficiency.

Eighth, we will promote the development of a full-fledged ruling party and develop the anti-corruption campaign into all kinds of medical device supervision. We will create a contingent of medical devices that are politically reliable, clean, clean, highly skilled and in good working style.