4. 1 Medical device procurement must adhere to the principle of "purchasing on demand and selecting the best", abide by relevant national laws and regulations, and ensure product quality.
4.2 The buyer must purchase qualified medical devices from an enterprise with a business license issued by the industrial and commercial department and a valid Medical Device Manufacturing Enterprise License or a Medical Device Operating Enterprise License, and verify the product certificate.
4.3 The purchased domestic products must have valid People's Republic of China (PRC) Medical Device Registration Certificate and Medical Device Product Production Approval Form, and the products must be within the product range of the supplier's Medical Device Manufacturing Enterprise License or Medical Device Trading Enterprise License. When necessary, check the product and enterprise quality system.
4.4 The purchased imported products must have valid People's Republic of China (PRC) Medical Device Registration Certificate and Medical Device Product Registration Form, and the products must be within the product range of the supplier's Medical Device Business License.
4.5 The quality audit system shall be established for the varieties produced for the first time. Quality audit includes: obtaining product technical standards, signing quality assurance agreements, and establishing procurement contract files.
4.6 The buyer shall not purchase unqualified products or expired, invalid or obsolete medical devices.
4.7 The purchased medical devices shall have legal bills, and complete and true purchase records shall be established to ensure that the tickets, accounts and goods are consistent.
4.8 Enterprises shall catalog and file the product qualifications of all business varieties and the qualifications of their suppliers, and keep them properly. Regularly check the validity of qualifications and update them in time.
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