A sales record established by an enterprise engaged in the wholesale of Class II and Class III medical devices as well as the retail business of Class III medical devices shall include at least the following contents:
(a) the name, specification (model), registration certificate number or filing certificate number of the medical device, the quantity, unit price, and the amount of money
(ii) the production lot number or serial number of medical devices, expiration date, date of sale;
(iii) the manufacturer and manufacturer's license number (or filing certificate number).
Focused on sampling enterprise sales records, to confirm that the sales record items are in line with the requirements including but not limited to the above
II. Enterprises engaged in the wholesale business of medical devices, the sales record should also include the name of the purchaser, business license number (or filing voucher number), business address, contact information.
Focused on sampling of enterprise sales records to confirm whether the sales record items meet the above requirements.
Three, engaged in the retail business of medical devices, enterprises should issue sales vouchers to consumers, record the name of the medical device, specifications (model), the name of the manufacturer, quantity, unit price, amount, retail unit, business address, telephone, date of sale, etc., in order to facilitate the quality of traceability.
Focus on sampling medical device retail sales vouchers to confirm whether the vouchers include the above specified content to facilitate quality traceability.
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