Producers should purchase packaging materials or small packages in contact with sterile devices from units that meet the conditions set forth in the "Rules for the Implementation of the Production", and should establish a management system for the purchase, storage, issuance and use of product packaging.
Unqualified sterile instruments and waste, expired sterile instrument product packaging or parts, must be in the factory on-site disfigurement or destruction, shall not be out of the factory.
Article 40 of the medical device business enterprises, the use of units shall not be operated, the use of non-registered according to law, no qualification documents, as well as expired, expired, out of medical devices.
Article 41 The transfer of medical devices in use between the use of medical devices, the transferring party shall ensure that the transfer of medical equipment is safe and effective, shall not transfer the expiration, expiration, elimination, as well as failed inspection of medical devices.
Article 66 If any of the following circumstances, the food and drug administration department of the people's government at or above the county level shall order rectification and confiscate the medical devices illegally produced, operated or used; if the value of the illegally produced, operated or used
medical devices is less than 10,000 yuan, a fine of 20,000 yuan to 50,000 yuan or less; if the value of the value of the value of the goods is more than 10,000 yuan, a fine of 5 times or more than 10 times; if the value of the goods is more than 5 times or more than 10 times, a fine of 5 times or more than 10 times. 5 times or more than 10 times the following fine; the circumstances are serious, ordered to suspend production and business,
until the original licensing department to revoke the medical device registration certificate, medical device manufacturing license, medical device license:
(a) the production, operation and use of medical devices does not comply with the mandatory standards or does not comply with the technical requirements of the products registered or filed;
( (B) the medical device manufacturer is not in accordance with the registered or filed product technical requirements for the organization of production, or not in accordance with the provisions of these regulations to establish a quality management system and maintain effective operation;
(C) the operation and use of no qualification documents, expired, invalid, obsolete medical devices, or the use of medical equipment is not registered in accordance with the law;
(D) food and drug supervision and management Department ordered in accordance with the provisions of this regulation to implement the recall or stop operating, but still refused to recall or stop operating medical devices;
(E) entrusted to do not have the conditions set out in this regulation of the enterprise production of medical devices, or did not manage the production of the entrusted party's behavior.
Article 67 One of the following circumstances, the food and drug administration department of the people's government at or above the county level shall order correction, impose a fine of 10,000 yuan or more than 30,000 yuan; if the circumstances are serious, shall order the suspension of production and business, until the original licensing department revoke the license to manufacture medical devices, medical device license:
(1) the production conditions of the medical device manufacturer has changed, No longer meet the requirements of the quality management system for medical devices, not in accordance with the provisions of these regulations to rectify, stop production, reporting;
(b) the production and operation of instructions, labeling does not comply with the provisions of this regulation of medical devices;
(c) not in accordance with the requirements of the medical device instructions and labeling requirements for the transport and storage of medical devices;
(d) the transfer of expiration, expiration, Out or failed test in use medical devices.
It can be known that the sale of expired medical devices is not allowed, can only be destroyed.