One, the license content: two, three types of medical equipment manufacturer qualification recognition
Two, set and implementation of licensing laws and regulations based on:
1, "Supervision and Administration of Medical Devices Regulations"
2, the State Food and Drug Administration, "Supervision and Administration of Medical Device Manufacturing Measures"
Three, the applicant needs to submit the material directory (in duplicate):
The applicant needs to submit a list of materials ( In duplicate):
1, "Medical Device Manufacturer License Application Form.
2, the legal representative, the person in charge of the enterprise's basic information and proof of qualifications.
Including ID card, proof of education, proof of title, original and copy of appointment documents, work resume.
3, a copy of the notice of pre-approval of the name of the proposed enterprise or business license issued by the administration for industry and commerce.
4, production site supporting documents and floor plan.
Property certificate or a copy of the lease agreement and the property certificate of the leased party; office, production, inspection, warehousing and other places of the floor plan, indicating the corresponding area.
5, the enterprise's production, technology, quality department responsible for the resume, education and title certificate of the original and a copy; relevant professional and technical personnel, skilled workers registration form, copies of certificates, and indicate the department and position; the proportion of senior, middle and junior technicians table;
Internal auditor certificate and inspector training certificate of the original and a copy.
6, the scope of products to be produced, varieties and related product profiles.
Product profiles include at least a description of the product's structural composition, principles, intended use and product standards.
7, the main production equipment and inspection instruments list.
8, production quality management standardized document catalog.
Mainly procurement, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, user feedback, adverse events and quality accident reporting system and other documents. Enterprise organization chart.
9, the process flow diagram of the proposed product, and indicate the main control items and control points.
Description of equipment, personnel and process parameter control for critical and special processes.
10, the proposed production of sterile medical devices, need to provide a clean room qualified test report.
Conforms to the management of sterile medical devices YY0033 standards of the relevant state departments recognized testing organizations issued within one year of the qualified test report,
11, the application material authenticity of the self-assurance statement.
Listing the catalog of declaration materials, and the material to make a commitment to bear legal responsibility for any false, stamped or signed by the legal representative.
...... For more information, please visit the official website of Freda Medical Device Consulting.