For Songjiang Class II Medical Device License

Medical device management supervision and management approach to the implementation of medical devices must be engaged in accordance with the corresponding norms, for the second class of medical devices engaged in the operation of the enterprise, must be the second class of medical devices for the record, the approach to clarify the second class of medical devices responsible for the main body, for the process and for the information.

First, for the filing of Class II medical devices required conditions

1, as a post approval qualification, you need to do a good business license;

2, the scope of business of Class II medical projects;

3, there is an actual office space;

4, qualified staff.

Second, for the record of Class II medical devices required information

1, business license, seal;

2, site use certificate;

3, legal representative, responsible for the enterprise, the person in charge of quality of the ID card and proof of academic qualifications (at least college education, the legal representative can be concurrently head of the enterprise);

4, the location of the registered address map and site plan.

Third, how to apply for Class II medical devices for the record

1, enter the Wuhu Market Supervision Bureau Class II medical device platform can view all the details of the process.

2, the use of legal person account login, is to register the company with the account, because to be associated with the enterprise information in order to normalize the process.

3, the audit can be issued through the second class of medical record card, print out their own, posted in the place of business in a prominent position.

Class II medical devices for the record is actually quite simple, as long as the conditions are met, the fast day can be successful.