We can understand this way, medical devices need to meet the regulations of all sales destination countries, if you are talking about imported medical devices to be sold in China, it must be registered in the SFDA and obtain a registration certificate; at the same time the medical device also needs to meet the requirements of Order No. 10, that is, the content of the label should include the registration certificate number;
As for the labeling whether it is a part of your packaging, it depends on your your own understanding. To emphasize is: imported medical devices in the domestic sales must have Chinese labels, the label must have SFDA approved registration certificate number.