Medical equipment business enterprises should be in accordance with the relevant provisions of the implementation of the unique identification system for medical devices. Engaged in the second and third class medical device wholesale business and the third class medical device retail business enterprises should establish sales record system. Sales record information should be true, accurate, complete and traceable.
Two, analysis
Medical device registrants, filers and business enterprises entrusted to other units of transportation, storage of medical devices, should be entrusted to the party's transportation, storage of medical devices to assess the quality of the ability to protect, and signed with its commissioning agreement to clarify the transportation, storage process of the quality of the responsibility to ensure that the transportation, storage process of quality and safety.
Three, what is the unique identification of medical devices?
Medical device unique identification by the product identification and production identification, product identification is to identify the registrant/recorder, medical device model specifications and packaging of the only code, is the keyword from the database to obtain information related to medical devices, is a must part of the unique identification. The production identification includes information related to the production process, including product lot number, serial number, production date and expiration date, etc. It can be used in conjunction with the product identification to meet the demand for fine identification and record keeping in the circulation and use of medical devices.