Medical device business enterprises on the goods should be what records

1. Purchase records, purchase records should indicate the following: the approved name of the medical device product, registration number, model, specifications, production batch, sterilization batch (if any), packaging labels and specifications of the status of the manufacturer, supplier, the number of goods purchased, date of purchase, expiration date (if any) and so on, and the signature of the person who purchased.

2. Acceptance records, acceptance of the content: the number of products, quality and packaging and labeling of three aspects; product quality acceptance, including the inspection of the appearance of the traits and packaging, labels, instructions and marking of the inspection.

Acceptance personnel in accordance with the legal standards for medical device products and the purchase contract for the quality of the terms and conditions set out in the warehousing vouchers, etc., on the purchase and sale of the product quality of the return of the batch-by-batch acceptance.

3. File records, records should at least include: human resources; personnel health checks; training and continuing education; suppliers and purchasers; the first enterprise; product quality information; purchase and acceptance; records out of the warehouse to review and sales; records of facilities and equipment; non-conforming products; returned products after sale management; quality accidents; medical device adverse events; medical device recall; bills and vouchers; medical device business e-regulation. vouchers; medical device business electronic monitoring report; customer information; after-sales service records and other content;

Operating companies should pay particular attention to warehouse records and sales records, involving product traceability.