2, the second step: log on to the system, check whether the city council audit. After the audit, you can submit paper materials to the municipal administrative services hall, the municipal window on-site license.
(B) need information
1, a copy of the business license;
2, the legal representative, the person in charge of the enterprise, the person in charge of quality of the identity, education or title certificate copy;
3, organizational structure and departmental setup description;
4, the scope of business, the business mode of operation description;
5, the business premises
5, business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copies, not in the demolition scope of the certificate;
6, business facilities, equipment catalog;
7, business quality management system, work procedures and other documents catalog;
8, basic information on the computer information management system and the function of the instructions
9, proof of authorization of the operator;
10, business license replacement lost statement; (not required for new start-ups);
11, scanned version of the application form signed and stamped with the official seal;
12, other supporting materials.
Note that!
(1) the above materials are required to be stamped with the original seal of the pharmacy;
(2) the uploaded documents are required to be in PDF or image format, with a maximum limit of 10M;
(3) when registering, please keep in mind the email address and password to log in again in case of subsequent changes in the license;
(4) for the 12 items of electronic materials to be submitted, the "※ " item is a mandatory upload item.
The validity of Class II medical device business filing certificate
Valid for five years, the expiration of the validity of the need to renew the registration, should be six months before the expiration of the validity of the renewal of registration to the original registration department to apply for renewal of registration.
According to the "supervision and management of the production of medical devices" in order to strengthen the supervision and management of the production of medical devices, standardize the production of medical devices, to ensure that medical devices are safe and effective.
According to the "supervision and management of medical devices regulations" developed by the "supervision and management of medical device production" Article XIII "medical device production license" is valid for five years, set out the license number, enterprise name, legal representative, responsible for the enterprise, residence, production address, production scope, the issuance of licensing department, the date of issuance and validity of the period of time and other matters.