On the 30th, the Kunming Food and Drug Administration issued the "Notice on the Work Plan for Centralized Remediation of Medical Device Circulation Activities". From now until September, it is targeting enterprises engaged in the operation of Class II and Class III medical devices in Kunming. There are eight types of illegal acts to conduct self-examination and conduct centralized supervision and inspection. Encourage the public to report violations of the company, unified reporting phone number: 12331.
1 Medical equipment wholesale enterprises are sold to enterprises that do not have qualifications or use units, and medical device management enterprises purchase medical equipment from non-qualified enterprises;
2 The operating conditions have changed, the rectification has not been carried out in accordance with the regulations, the address of the business premises or warehouse has been changed, the business scope has been expanded, or the warehouse has been set up without authorization;
3 Providing false information or taking other deceptive means to obtain the Medical Device Business License, providing false information when not filing or filing. Forging, altering, trading, leasing, lending "medical device business license" or "medical device operation record certificate";
4 If you are engaged in the operation of the third type of medical device without permission, or continue to operate after the expiration of the validity period of the Medical Device Operation Permit;
5 to operate the second and third types of medical devices that have not obtained the medical device registration certificate, especially the domestic agents of imported medical devices to operate unlicensed products;
6 To operate medical devices that do not meet the mandatory standards or do not meet the technical requirements for registered or filed products, and operate medical devices that do not have conformity documents, expired, expired, or eliminated;
7 The medical device manuals and labels that are in operation do not comply with the relevant regulations, and the medical devices are not transported and stored according to the medical device instructions and labeling requirements. In particular, the cold chain management of the whole chain is not required for low temperature and refrigerated medical devices;
8 The medical device purchase inspection and record system was not established and implemented according to the regulations. The operating enterprises engaged in the second and third types of medical device wholesale business and the third type of medical device retail business did not establish and implement the sales record system as required.
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