1.？ Operation Record Form of Class II Medical Devices
2.？ business license
3.？ A copy of the identity certificate, education or professional title certificate of the legal representative and the person in charge of quality.
4.？ Description of organization and department settings
5.？ Description of business scope and mode of operation;
6.？ A copy of the geographical location map, floor plan, house title certificate or house lease certificate of the business premises and warehouse address;
7.？ Catalogue of business facilities and equipment;
8.？ Catalogue of documents such as management quality system and working procedures;
9.？ Agent authorization certificate.
(1) How to tell whether it is a Class II medical device?
1、? The commodity package is marked with the word XXXXNo of "US Food and Drug Administration (quasi)". 1XXXXXX "is a class of medical devices, which need not be filed;
2、? Commodity packaging marked with "US Food and Drug Administration (quasi) word XXXX No.2 2XXXXXX" is a Class II medical device, which needs to be filed;
Note: According to the provisions of the Measures for the Supervision and Administration of Medical Device Operation: "Enterprises engaged in the operation of Class II medical devices shall file with the municipal food and drug supervision and administration department with districts". If the goods you sell belong to Class II medical devices, you need to file the qualification of Class II medical devices at the time of release. Moreover, after the Taobao store is filed, only the products with the same business scope as the second-class medical device filing certificate are allowed to be released.