Do medical device packaging changes need to be filed?

Need. According to the query of China Medical Network, the change of medical device label needs to be filed, and the change needs to obtain a new certificate issued by the competent department of medical devices to allow the product to go on the market, and the corresponding documents should be submitted, including: if the change does not need the approval of the competent department of medical devices in the country (region) where the registrant is registered or the place where the production address is located, it needs to be explained; Innovative medical devices that are not listed overseas shall not be submitted.