Imported medical equipmentHow does China manage the classification of imported medical devices？ Medical equipment refers to instruments, equipment, utensils, in vitro diagnostic reagents and markers, materials and other similar or related articles used directly or indirectly on the human body，Including the required computer software;It is mainly obtained by physical means，Related to pharmacology, immunology, metabolism or any of these methods，But they only play a supporting role。The goals include: diagnosing, preventing, monitoring, treating or mitigating disease;Diagnosis, monitoring, treatment, remission or functional restoration of injury;Examination of physiological structures or processes;To replace, regulate, or support;Life support or maintenance;Pregnancy control;To provide medical or diagnostic information by examining a human sample。
Medical equipment classification and management
01
According to the degree of risk of medical devices, they are classified and managed。
Level 1: Low risk, routine management can ensure its safe and effective medical device and product filing management。
Type 2: Medium risk, strict control and management are required to ensure the safety and effectiveness of medical devices, and the implementation of product registration management。
Level 3: High risk, special measures should be taken to strictly control management, ensure the safety and effectiveness of medical devices, and implement product registration management。
When evaluating the risk level of medical equipment, factors such as the intended purpose, structure and method of use of the medical equipment should be taken into account。
02
Filing and registration
Refers to the enterprise or research and development institution that has obtained the registration certificate of medical devices and the filing of medical devices。
Medical device registrants and recordholders shall be responsible for strengthening the safety and effectiveness of the entire life cycle, production, management and use of medical devices in accordance with law。
The recordholder shall submit the recordkeeping materials to the drug regulatory department of the local municipal people's government divided into districts。When applying for the registration of Class II medical device products, registration application materials shall be submitted to the drug regulatory department of the local province, autonomous region or municipality under the Central government。The registration applicant shall file an application with the drug regulatory department under The State Council for the registration of Class III medical device products。
For the first batch of imported Chinese Category I medical devices, the overseas filing party shall submit the filing materials to the drug regulatory department under The State Council, and the certification document approved by the national (regional) competent department for marketing。For innovative medical devices that are not listed overseas, they shall not submit the marketing documents approved by the competent authorities of the country (region) where the recordholder is located。
The overseas registration applicant for the export of Class II and Class III medical devices shall be submitted by the state-designated enterprise legal person to the drug regulatory department under The State Council for registration application materials and shall be approved by the competent department of the country (region) where the registration applicant is located。Innovative medical devices that are not listed overseas may not submit the marketing certificate of medical devices approved by the competent authorities of the country (region) where the registration applicant is located。
The company's product records and registration shall provide the following information: product risk analysis data, product technical requirements, product inspection reports, clinical evaluation materials, product specifications, label samples, product development and production quality management system documents, product safety and effectiveness of other information。