The second class of medical devices for the record voucher process
The second class of medical devices for the record voucher process - the second class of medical devices for the record voucher for the materials to be submitted
1, a copy of the business license;
2, the legal representative, the person in charge of the enterprise, the person in charge of quality Identification, education, or proof of title;
3, organizational structure and departmental setup;
4, business scope, business mode description;
5, business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or a copy of the lease agreement (accompanied by documents proving ownership of the house), is not in the scope of the demolition of the certificate;
6, business facilities, equipment directory;
7, business quality management system, work procedures and other documents directory;
8, computer information management system basic information and functional description;
9, the operator's authorization to certify;
10, the business license to reissue the lost statement; (new start-ups do not need);
11, signed and stamped scanned version of the application form;
12, other supporting materials
The second class of medical equipment record vouchers for the process
1, the first step: upload the electronic version of the material online: log on to the State Drug Administration website - Services -Online Office Guide - Medical Device Manufacturing and Operation License Filing - Apply for Enterprise - First Time Usage Registration - registration is complete, fill out the application form in accordance with the requirements - upload electronic materials. Upload successfully, waiting for the City Council audit.
2, the second step: log in to the system, check whether the city bureau audit passed. After the audit, you can submit paper materials to the municipal administrative services hall, the municipal office window on-site license.
The second class of medical equipment record vouchers are valid for a few years
Valid for five years.
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, the person in charge of the enterprise, residence, production address, the production range, the issuance of licensing department, the date of issuance and validity of the period of time and other matters.
The scope of business of Class II medical devices for the record
X-ray film machine, ultrasound, microscope, biochemistry instrument belongs to Class II.
Class II means that the safety and effectiveness of medical devices should be controlled.
According to the "supervision and management of medical devices regulations" legal basis for Chapter IV, Article 30: 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 government of the food and drug supervision and management department for the record and submit it to comply with the conditions of Article 29 of the Ordinance.
Article 29 to engage in medical device business activities, there should be with the scale and scope of operation of the business premises and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.