The materials required for the filing of Class I medical devices include: a copy of the business license of the enterprise, a copy of the organization code certificate, a legal person ID card, a certificate of education of the production and quality manager, major production equipment and testing equipment, product risk analysis data, safety risk analysis report, product technical requirements and a list of products that meet the national industry standards.
Legal objectivity:
According to Article 9 of China's Regulations on the Supervision and Administration of Medical Devices, the following materials shall be submitted for the filing of Class I medical device products and the application for registration of Class II and Class III medical device products: (1) product risk analysis materials; (2) product technical requirements; (3) product inspection report; (4) Clinical evaluation data; (five) product specifications and label samples; (6) Quality management system documents related to product development and production; (seven) other information required to prove the safety and effectiveness of the product. Applicants and filers of medical device registration shall be responsible for the authenticity of the submitted materials.