Basic requirements for the content of the system:
1, the sale of medical devices should be based on the relevant laws and regulations require that the products are sold to the business unit with the "business license" issued by the industry and commerce department, and with a valid "Medical Device Business Enterprise Record Sheet" or "Medical Device Business Enterprise License" or a practice license of the Medical institutions. (Except for sales to individuals)
2, sales of products to make sales records. If necessary, should be able to trace out all the products sold according to the sales record and recovery. Sales records should include: product name, production unit, specifications, date of production, factory number, date of sale, sales unit, sales volume, the operator.
3, sales records should be kept until the expiration date of the product or use more than one year after the expiration date.
4, the sale of special management products, should be strictly in accordance with relevant state regulations.
5, the enterprise should implement control of product returns, and establish records. Records should include: product name, production unit (supply unit, specifications, factory number, production date, return unit, return date, return quantity, return reasons and results.
6, to do after the product is sold, regular or irregular return visits to the user, the product quality, delivery and service aspects of the customer's reflection to respond in a timely manner, but also through questionnaires, phone calls, customer forums, symposiums, opinion books and other forms of collection of customer comments or suggestions, after analysis, utilization, and ultimately the improvement of the services of the enterprise.