Class II medical devices must be packaged

The specific packaging requirements are as follows:

1. The product should be marked as follows: manufacturer name, product name, specifications Model, production date, product number, registered product standard number, product registration number.

2. The product packaging should have the following markings: manufacturer name, factory address, trademark, specifications, product name, production batch number or date, sterility and expiry date, the words "single use" or Graphic symbols.

3. The box packaging should have the following markings: product name, specifications and the name of the items inside? Use the graphic symbols or corresponding text instructions given in YY0446 to indicate the sterility of the product, production batch number or date , Expiration date, manufacturer name and address? Product registration certificate number, production enterprise license number, implementation standards. The inspection certificate and product instruction manual should be placed inside the package.

4. The packaging box should be marked with the following: manufacturer name, address, product name, specifications, trademark, date of manufacture or batch number, product registration number or batch number, quantity, volume, quality, sterility and expiration date Single use? "Handle with care" and other words and signs should comply with the provisions of GB191

5. The label and certificate should have the following information: manufacturer name, product name, original inspection code number, inspection date? "Qualified" word.

Extended information:

In order to further strengthen the management of medical devices and various labels and packaging markings, it was reviewed and approved by the State Food and Drug Administration on June 18, 2004. , which came into effect on July 8, 2004 - "Regulations on the Management of Instructions, Labels and Packaging Markings of Medical Devices". According to the provisions of Article 19 of the "Regulations on the Management of Medical Device Instructions and Labels", the "Regulations on the Management of Medical Device Instructions and Labels" came into effect on October 1, 2014. The "Regulations on the Management of Instructions, Labels and Packaging Markings of Medical Devices" (formerly State Food and Drug Administration Order No. 10) promulgated on July 8, 2004 were abolished at the same time. ?

Reference:

State Food and Drug Administration—State Food and Drug Administration Order No. 6