According to the "supervision and management of medical devices regulations" and other relevant provisions, in order to ensure that the quality of medical devices in good condition, the number of accurate, specially developed this system.
Second, the acceptance of personnel should be trained, familiar with the medical device law and professional knowledge, the test qualified for duty.
Third, the acceptance of medical devices should be handled in accordance with the "supervision and management of medical devices regulations" and other relevant regulations. Against the goods and delivery vouchers, the name, specifications, model, manufacturer, batch number (production batch number, sterilization batch number), expiration date, product registration number, quantity, etc., the goods do not match the bill of lading, quality anomalies, packaging is not solid, vague labeling and other issues, shall not be warehoused, and reported to the quality control department.
Four, the acceptance of imported medical devices should be consistent with the following provisions:
(a) the acceptance of imported medical devices, the supply unit must provide the supply unit stamped with the original seal of the "Certificate of Registration of Medical Devices", "Medical Device Product Registration Form" and other copies.
(B) the acceptance of imported medical devices should be clear about the following:
1. Check whether the imported medical device packaging, labeling, instructions with the use of Chinese;
2. Marked product name, specifications, model number is consistent with the certificate of registration of the product;
3. Instruction manual of the scope of application of the scope of application is in line with the provisions of the registration certificate;
4. Whether the product trade name labeling is consistent with the "medical device instructions, labels, packaging labeling regulations";
5. Whether the labeling and packaging labeling is in line with national, industry standards or the provisions of the registered product standards.
V. Acceptance of the first varieties should be the first batch of acceptance of the first batch of the same batch number of medical devices factory quality inspection report.
Sixth, the packaging should be marked on the production license number and product registration number; no certificate of conformity in the box of medical equipment shall not be accepted.
Seven, with the acceptance of the content does not match, the acceptance of the acceptance of the right to refuse to accept, fill out the 'rejection notice', the quality of doubtful fill out the 'quality re-inspection notice', report to the Ministry of Quality to deal with the Department of Quality to confirm that, when necessary, to send the relevant The quality department will confirm and send to the relevant testing department for testing if necessary; if the quality is confirmed as unqualified, it will be dealt with according to the management system of unqualified medical devices, and if the quality is unqualified, it will be notified by the quality department to contact with the purchasing department and the supplying unit for the return and replacement of the goods.
Eight, the sale of returned medical devices, should be batch by batch acceptance, qualified into the qualified products area, and make a good return acceptance records. Quality in doubt should be sampled for inspection.
Nine, the goods should be warehoused into the first to be tested area, to be tested without acceptance shall not be canceled to be tested into the warehouse, and shall not be sold.
Ten, pay attention to the expiration date, generally less than six months of the expiration date shall not be warehoused.
Xi, the inspection does not meet the quality standards and have doubts about the medical equipment, should be stored separately, labeled. And immediately notify the business and quality control department in writing for processing. Before making a decision to deal with the opinion, shall not cancel the marking, not to mention the sale.
Twelve, acceptance is complete, do a good job of medical equipment warehousing acceptance records. Storage acceptance records must be recorded: the date of acceptance, supply units, acceptance of the number, name, specifications (model), manufacturer, batch number (production batch number, sterilization batch number, expiration date, registration number, quality, such as the operator. Medical device warehousing acceptance records must be saved to more than the expiration date or shelf life after 2 years.