What should I hold to operate Class II medical devices?
Business class II medical devices, the first thing you must have the company's business license. Then you need to be ready to operate the company's Class II medical devices are organized into an Excel table, the form must be Tianming product name specifications, registration number belongs to the Class II classification and stamped, and then log on to the State Food and Drug Administration Web site, register the company's name in the Web site for the application of Class II medical device filing.
After filling out the application form, the form will be printed out with a copy of the business license, corporate authorization and a copy of the registration certificate of Class II medical device goods, stamped with the seal and statistics of the total form to the designated pharmacovigilance or the market management of the Pharmaceutical Department of the paper audit.
After the audit is completed and confirmed to be correct, the information is uploaded in the system. Then the Drug Administration prints the Class II medical device filing form. Business license and Class II filing form are complete before the sale of Class II medical devices.
Medical device license Class I, Class II, Class III difference?
According to the latest "supervision and management of medical devices regulations" (State Council Decree No. 650) and "quality management standard for the operation of medical devices", first of all, we need to understand that medical devices are divided into three categories: Class I, Class II, Class III, the current operation of a class of products is not required to apply for a license for the operation of medical devices, business class II products are required to apply for Class II medical device business filing vouchers, the operation of Class III products is to apply for a medical device business license. The product is to apply for the medical device license.
What is the online filing process for Class II medical sales?
The online filing process for 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 the quality of the identity of the person in charge of the certificate, education or title certificate;
3, organizational structure and departmental setup;
4, scope of business, the business of the person in charge, the business of the person in charge of the quality of the identity of the person in charge of the certificate;
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.
What are the requirements for the filing of Class II medical devices?
Should have with the business scale and scope of operation of the business premises and storage conditions and so on.
Engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of the municipal people's food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 29 of the Ordinance, that is, to engage in the operation of medical devices, there should be with the scale of operation and the scope of operation of the business premises and storage conditions, as well as with the operation of the medical device quality management system and quality management institutions or personnel. Management system and quality management organizations or personnel.
Medical equipment business enterprises, the use of units to purchase medical devices, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system.
Engaged in the second and third class of medical devices wholesale business and the third class of medical devices retail business enterprises, should also establish a sales record system.
What is the meaning of Class II medical device record certificate?
According to the "Regulations for the Supervision and Management of Medical Devices" operation of Class II medical devices need to apply for Class II business filing vouchers, in Sandy City Council, vouchers are valid for five years, in the application for continuation shall be applied for six months in advance.