Title: Shandong Province and Drug Administration on the issuance of medical equipment business "twelve not allowed" notice
Shandong Province, medical equipment business "twelve not allowed"

One is not allowed to engage in the operation of the third class of medical devices without authorization

Shandong Province, the medical device business "twelve forbidden"

One, not allowed to engage in the third class of medical equipment business without permission, without filing in the second class of medical equipment business activities;

Two, not allowed to forge, altered, trading, leasing, lending of medical equipment business licenses;

Three, not allowed non-medical device registrant, filing, or medical equipment business enterprises engaged in the sale of medical equipment network;

Three, not allowed to operate in the medical device business is not registered according to law or filed medical devices;

Fifth, is not allowed to operate does not meet the mandatory standards or by the registrant to record the technical requirements of the product medical equipment;

Sixth, is not allowed to operate without a qualified document, expired, invalid, obsolete medical equipment;

Seventh, is not allowed to operate without the Chinese manuals, Chinese labels of imported medical devices;

Eighth, is not allowed to purchase from the supplier who does not have the legal qualifications of medical equipment;

Here are some examples of medical equipment that are not allowed to operate without the Chinese manuals, Chinese labels. Medical devices;

nine, not allowed to medical equipment business enterprises are not required to establish and implement the purchase inspection records system;

ten, not allowed to engage in the second, three types of medical equipment wholesale and retail business of Class III medical equipment business enterprises are not required to establish and implement the sales records system;

eleven, not allowed to violate the instructions and labeling requirements of medical equipment transportation and storage of medical equipment;

none. Storage of medical devices;

twelve, are not allowed to change the business premises and storage conditions.

The new revised "supervision and management of medical devices regulations" has been June 1, 2021 implementation. Violation of the above circumstances will be punished according to law. Scan the QR code to see the full text of the Regulations on the Supervision and Administration of Medical Devices.

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