Apply for a medical device license conditions:
1), the person in charge of the enterprise need to be familiar with the supervision and management of medical devices and the rules and regulations of the management of medical devices and related knowledge.
2), with the scale of operation and business scope of the appropriate quality management organization or full-time quality management personnel.
3), with the scale and scope of operation of relatively independent business premises.
4), the warehouse area of not less than 100 square meters.
5), the operation of Class II medical device products, the registered capital should be not less than 500,000 yuan.
6), need to establish a sound product quality management system.
7), the enterprise should be equipped with computer equipment and management software appropriate to the scale of operation.
Application for medical device license application materials:
1), "medical device license application form" (in triplicate).
2), the industrial and commercial administration department issued by the enterprise name pre-approval documents or "business license" copy.
3), Capital Verification Report provided by the registered accounting firm.
4), a copy of the personal resume, ID card, academic certificate or title certificate of the legal representative of the proposed enterprise and the person in charge of the enterprise.
5), the person in charge of the quality management organization's identity card, personal resume, medical equipment or related professional bachelor's degree certificate or national? Recognition of the relevant grasp also a copy of the intermediate title certificate or above, more than 2 years of experience in medical equipment work experience, I signed the on-the-job in the post without part-time work, no adverse records of the statement of assurance, labor and employment contract. Full-time management personnel ID card, resume, medical device related professional college degree or above, or nationally recognized certificate of the relevant professional title above junior, signed by the person on duty without part-time, no adverse records of the statement of assurance.
6), the company's personnel list (indicating name, gender, age, education, position, title, identity card number): the list of academic qualifications attached to a copy of the academic certificate; title attached to a copy of the title certificate.
7), the proposed enterprise registered address, warehouse address of the lease agreement, a copy of the certificate of property rights, floor plan (indicating the area) and geographical location map.
8), the proposed enterprise organization and function.
9), the proposed enterprise product quality management system documents and storage facilities, equipment catalog.
10), the proposed business scope of the enterprise in accordance with the medical device classification catalog specified in the management category, class code name.?
The time is very fast at most one month. Although the region is not the same but it is similar.