today (5 moon 26 day) , According to the official website of the National Medical Products Administration, Jiao Hong, Director of the National Medical Products Administration, proposed at the Third Session of the 13th National Committee of the Chinese People's Political Consultative Conference, Strengthening the construction of emergency management system for drugs and medical devices, Improve the system and mechanism for major epidemic prevention and control, Accelerate the promotion of professional and specialized inspectors, Construction of the reviewer team, etc.

5 moon 21 day, Guangdong Food and Drug Administration announces that some inspectors have passed the assessment, It is reported, Currently, several provinces have established professional medical device inspection teams, Jiangxi, Shaanxi, Hebei, Shandong, Zhejiang, Shanghai, etc.

This means, In medical device inspection, The most professional inspector is coming, The State Council has previously issued "Opinions on Establishing a Professional and Professionalized Team of Drug Inspectors" .

The document emphasizes, Professional and specialized medical device inspectors refer to those recognized by drug regulatory authorities, Legally regulate the involvement of management parties in drug development, Production and other places, Personnel responsible for compliance confirmation and risk assessment of activities.

document stipulations, In terms of inspection system and mechanism, It will be divided into two inspection teams: national and provincial, Equip full-time inspectors who meet the requirements of inspection work.

Specifically, On site inspection of the research and development process of major medical devices by the regulatory authorities of the State Council, Compliance inspection will be conducted on the implementation of quality management standards for clinical trials of medical devices. Undertake on-site inspections of medical devices overseas and major causal inspections in the production process.

The provincial drug regulatory authorities mainly conduct on-site inspections of the production process of medical devices, And compliance checks on the implementation of production quality management standards.

Directly enter the sudden inspection of the equipment company

One fact is that, No enterprise is perfect, It's impossible to have no omissions, So the country's increased inspection efforts are aimed at promoting the production and circulation of the medical industry towards a healthier direction.

And without notifying, No greeting, One of the best ways to see the real situation is to directly target the enterprise. Undercover investigation is this method, Flight inspection is also the same.

For flight inspection, It mainly focuses on the production quality management system of enterprises, The purpose of the professional inspection team traveling thousands of miles to the enterprise is to point out problems, Urge enterprises to continuously improve their production quality management system.

For undercover investigations, The Hubei Provincial Drug Administration has previously released "Provincial Bureau conducts province wide drug safety undercover investigation and research" Notification of, dispatch 5 A secret investigation team, to the enterprise, Medical service institutions, Grassroots regulatory agencies conduct research, The scope of involvement includes the field of medical devices.

Self inspection and rectification of these projects

For enterprises and distributors, medical institution, Before the inspection agency arrives, Self inspection and rectification is the most important thing to do now, Which business behaviors are the focus of self-examination and rectification?

under inspection, If the enterprise discovers serious violations and illegal activities during inspection, Revoke all business licenses, And publicly disclose it to the society. For those suspected of committing crimes, Transfer to the public security department.

At the same time, the legal representative and main person in charge of the enterprise shall be included in the blacklist management in accordance with the law, And disclose their name and identity information to the public; Report to relevant departments according to regulations, Implement joint punishment.

From past cases, it can be seen that, Dealing with unauthorized enterprises' votes, Falsely issuing invoices, Punishment for illegal activities such as unlicensed operation, The State Administration of Taxation and the public security organs will not be soft handed. The company involved in the case has been severely held accountable, give criminal sanctions.