First, 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 storage is intact, the number of accurate, specially formulated 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.
Fourth, 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) acceptance check items:
1. Check the imported medical device packaging, labeling, instructions, whether the use of Chinese,
2. Labeled product name, specifications, model number is consistent with the provisions of the certificate of registration of the product,
3. Instruction manual of the scope of application of the scope of application of the certificate is consistent with the provisions of the registration,
4. Product trade name labeling is consistent with the "medical device instructions, labels, packaging labeling regulations",
5. Labeling and packaging labeling is consistent with national, industry standards or registered product standards.
V. Acceptance of the first varieties should be the first batch of acceptance of the arrival of the same batch number of medical devices factory quality inspection report.
Six, the packaging should be marked on the production license number and product registration number; box without a certificate of conformity of the medical device shall not be accepted.
VII, with the acceptance of the content does not match, the acceptance officer has the right to refuse to accept, fill out the 'rejection notice', the quality of the doubtful fill out the 'quality re-inspection notice', report to the Department of Quality Management to deal with the Department of Quality Control to confirm, if necessary, to send the relevant Detection department for testing; confirmed as unqualified intrinsic quality in accordance with the management system of unqualified medical devices for processing, unqualified for the external quality of the Department of Quality Control to notify the purchasing department and the supply unit to contact the return of goods.
VIII, 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.
IX, warehousing goods should be first into the pending inspection area, pending inspection of goods without acceptance shall not be canceled pending inspection into the warehouse, and shall not be sold.
X. Pay attention to the expiration date when warehousing, 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, marked. 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, and shall not be sold.
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 of items, 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 kept until more than the expiration date or shelf life of 2 years after the expiration.
Medical device sales record system
I. The sales of medical devices must strictly implement the "Regulations on the Supervision and Administration of Medical Devices", "Economic Contract Law", "Product Quality Law" and other relevant laws, regulations and policies, and legal business.
Second, the sales staff must be trained and qualified for duty.
Third, the sale of medical devices should be selected with legal qualifications of the unit.
Fourth, the sale of medical devices in accordance with the requirements of issuing legal bills, according to the provisions of the establishment of sales records, records should be detailed and specific, to facilitate the quality of tracking, sales records, including: the date of sale, sales to the unit, the name, specifications (model), quantity, unit price, manufacturer, quality, handler, etc., the records should be preserved in accordance with the provisions of the more than the expiration date or the expiration of the shelf life of 2 years.
Fifth, the sale of medical devices should be 100% out of the warehouse review, quality assurance, to eliminate substandard products out of the warehouse.
Six, salesman should be regular or irregular door-to-door solicitation or letter to the customer's opinion, seriously assist the quality control department to deal with customer complaints and quality problems, and improve the quality of service in a timely manner.
Medical equipment purchase and acceptance system
Basic requirements of the system:
1, acceptance of the personnel must be strictly based on the relevant standards and purchase contracts on the purchase of products batch by batch inspection and acceptance of the inspection should be complete, standardized, and should be recorded. Acceptance, acceptance of personnel should be signed in the medical equipment warehousing voucher.
2, inspection items should include:
1) product name, specifications, quantity and other basic information is consistent with the purchase ticket.
2) whether the product at the storage meets the requirements of the relevant standards, whether intact;
3) whether the marking is clear and complete;
4) Imported medical devices should have Chinese labels, Chinese instructions;
5) the need for special management of the product: orthopedic implantable medical devices, filler materials, implantable medical devices, infant incubators and keratoplasty lenses, in accordance with the relevant provisions of the State and relevant standards. Relevant state regulations and relevant standards for inspection; single-use sterile medical devices according to the State Drug Administration, "single-use sterile medical device business enterprise qualification recognition of the implementation of the rules (provisional)" and the book "single-use sterile medical devices to carry out goods inspection control procedures".
6) shall comply with relevant regulations or other requirements specified in the purchase contract.
2, inspection records include at least: product name, production unit, supply unit, specifications, date of production, factory number, test items, test results, inspection date, inspection personnel.
3, purchase and acceptance records should be kept until the product expiration date can be used more than one year after the expiration date.