Class II medical devices must be packaged
Specific packaging requirements are as follows:
1, the product should have the following markings: the name of the manufacturing unit, product name, specifications, date of manufacture, product number, ? Registered product standard number, product registration number.
2, the product should be packaged with the following markings: ? Manufacturer's name, address, trademark, specifications, product name, production lot number or date, sterility and expiration date?
3, the package box packaging should be the following markings: product name specifications and the name of the items inside? With YY0446 kinds of graphic symbols given or the corresponding text description shows that the product is sterile, production batch number or date, expiration date, manufacturer's name and address? Product registration certificate number, manufacturer's license number, implementation standards. Packaging should be placed in the inspection certificate, product instructions.
4, the box should have the following markings: the name and address of the manufacturer? Product name, specifications, trademarks, factory date or batch number, product registration number or batch number, quantity, volume, quality sterile and expiration date of a use? "Carefully and gently" and other words and signs should be consistent with the provisions of GB191
5, labels and certificates of conformity should be the following information: the name of the manufacturer, the name of the product, the original code of the test, the date of inspection? "Qualified" words.
Expanded Information:
In order to further strengthen the medical device and a variety of labels and packaging markings Management, etc., June 18, 2004 by the State Food and Drug Administration Board of Directors to consider and adopt, since July 8, 2004 shall come into force - "medical device instructions, labels and packaging labeling regulations. According to the "medical device instructions and labeling regulations" Article 19 of the provisions of the "Medical Device Instructions and Labeling Regulations" shall come into force on October 1, 2014.The "Medical Device Instructions, Labeling and Packaging Labeling Regulations" (former State Food and Drug Administration Decree No. 10) published on July 8, 2004, is repealed at the same time.?
References:
State Drug Administration-State Food and Drug Administration Decree No. 6<