Class II medical sales online filing process?
The online filing process of Class II medical devices:
Application for Class II medical device business record should be submitted to the information:
1, business license;
2, legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the certificate, certificate of qualifications or titles;
3, organizational structure and departmental setup instructions;
4, the scope of business, business mode description;
5, business premises, warehouse address of the geographic location map, floor plan, documents proving property rights of the house or lease agreement; (with documents proving property rights of the house)
6, business facilities, equipment directory;
7, business quality management system, work procedures and other documents directory;
8, to encourage the Use of computer information management system;
9, proof of authorization of the operator;
10, signed and stamped scanned application form;
11, other supporting materials.
For the filing of Class II medical device license required personnel documents are which certificates?
Legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity card, proof of education or title certificate copy r Simply put, the legal person, the person in charge, the person in charge of the quality of the identity card copy; quality of the person in charge of the college diploma or above, or intermediate or above the certificate of the title copy. r If these three are a person, only need to provide the person's identity card copy, proof of education or title certificate photocopy.
How to apply for a Class II medical device license?
First register the company
Go to find the materials needed to apply for, generally go to the local government service center or the Market Supervision Bureau to find, really can not go to the Drug Administration there to consult, some sites do not have they will send you the information in the mailbox, there are places to find out the phone number, you just go directly to the local Drug Administration to bring a copy of the disk on the line
In accordance with the to go to fill out the information A, need to declare online on the online declaration, the second category of direct filing, you can take the paper materials and disk directly is the Drug Administration for the record, the materials qualified the same day you can get a license.
Class II is the record certificate, Class III is the license
Extended knowledge: Class II medical devices
means, on its safety, effectiveness should be controlled medical devices. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.
Does a Class II medical device license require an annual report?
The filing of Class II medical devices does not require annual review. According to Article 13 of the Measures for the Supervision and Administration of the Manufacture of Medical Devices, the filing license is valid for 5 years.
At the same time, according to the provisions of its Article XVII of the "Medical Device Manufacturing License" expiration of the continuation of the medical device manufacturers should be valid since the expiration of six months before the original licensing department for the continuation of the "Medical Device Manufacturing License" application.