Raid Flight Inspection The State Bureau notified a number of arms enterprises (attached list)

Medicine Network August 28 - August 24, the State Drug Administration Audit and Inspection Center announced the first batch of 2020 medical device flight inspection summary.
a total of 11 medical device manufacturers were tested by the State Bureau for flight, and a total of 110 defects were issued.
for the flight inspection, is mainly concerned about the enterprise's production quality management system, professional inspection team not far from the purpose of the enterprise is to point out the problem, urge the enterprise's production quality management system for continuous improvement.
, the state and multi-provincial drug regulatory departments issued "medical device flight inspection management measures", sampling, flight inspection has been carried out.
fact is that enterprises are not perfect, can not be without omissions, so the state stepped up inspection is to make the medical industry production and flow to a healthier direction.
way to see the real situation in a way that doesn't give notice, doesn't say hello, and plugs into the business.
is this way, so is flight inspection.
for the flight inspection, is mainly concerned about the enterprise's production quality management system, professional inspection team not far from the purpose of the enterprise is to point out the problem, urge the enterprise's production quality management system for continuous improvement.
For covert visits, the Hubei Provincial Drug Administration has issued a notice "provincial bureaus to carry out the province's drug safety secret visit research" notice, sent five secret visiting groups to enterprises, medical services, grass-roots regulatory agencies to conduct research, covering the field of medical devices.
In the way of inspection, the covert visit will take the way of not informed in advance, do not say hello, do not listen to the report, do not accompany the reception, go straight to the grass-roots level, directly plug in the scene, to find the outstanding problems and weak links existing in the enterprise.
self-examination and rectification, the State Health Insurance Administration has released a list of administrative law enforcement matters (2020 edition), which mentions that high-value medical supplies will be inspected.
for enterprises and the vast number of dealers, medical institutions, before the inspection agencies did not arrive, self-examination and rectification is the most important thing to do now, self-examination and rectification of which business practices are the focus? 1. Provide places, qualification documents and bills for other people to operate medical devices illegally.
2. Purchase medical devices from individuals or undocumented units.
3 to units or individuals without legal qualifications.
4. The source of the purchase of counterfeit equipment.
5. Fictitious medical device sales flow.
. Tampering computer systems and monitoring systems to conceal real medical device purchase and sale records, bills, vouchers, data.
7. The records of the purchase and sale of medical devices are incomplete, untrue, and the business practices cannot be traced.
. When purchasing and selling medical devices, the license, invoice, accompanying companion notes, physical accounts, financial accounts, equipment in kind, and purchase prices cannot correspond to each other.
9. Medical devices are not in storage, off-account accounts are set up, and are not included in the quality system management of enterprises.
10. Storage of medical devices in places other than approved addresses.
11. Medical devices are not transported as required.
12. Change the registered address, mode of operation and scope of business without authorization.
, if an enterprise inspects a serious violation of the law, it shall revoke its business license and make it public to the public.
to the public security organ department for suspected crimes.
shall at the same time incorporate legal representatives and principals of enterprises into the management of the blacklist in accordance with the law, and publish their names and identity information to the public;
from past cases, the General Administration of Taxation and the public security organs are never soft on the punishment of illegal acts such as ticketing, false indinging and undocumented operation of illegal enterprises.
enterprises involved in the case are severely held accountable and held criminally responsible.
Whether it is flight inspection or covert visits, are not closed to the armed enterprises to carry out discipline, issued a "correction order", from the source to control the "stain" of the outflow of enterprise products, enterprises if they want to do "to check not alarmed", must be in their own production and management of strict implementation of the relevant provisions.
110 defects were made public.