1. Request and review of the first enterprise stamped with the original seal of the "Medical Device Manufacturing (Business) License" or the record certificate, "Business License" and the annual report of the industrial and commercial inspection, the tax registration certificate and other information and retained on file.
2. To obtain the relevant product medical device registration certificate or product filing certificate.
3. For a copy of the ID card of the sales staff and the original power of attorney stamped with the original seal of the first enterprise. The letter of authorization should contain sales of varieties, geographic area, period, indicating the salesperson's identity card number.
4. For the purchase of Class B medical equipment suppliers, but also need the following information: such as direct agency for the manufacturer, there must be the original seal of the original seal of the supplying company's power of attorney; such as non-producer direct agency, there must be a supplier of enterprises to sign with a clear responsibility for the quality of both sides of the quality of the "Quality Assurance Agreement".
5 the information requested should have integrity, authenticity and effectiveness.
6. Audit whether the company's license is beyond the scope of production (business) and mode of operation.
7. Must audit whether the medical devices purchased from its products within the approved scope of its production (business) license.
8. Audit of the first enterprise information can not ensure that its quality assurance capabilities, should be organized to carry out site visits, and focus on its quality management system to meet the product quality requirements of medical devices.