What qualifications are needed for Class II medical devices

The qualifications required for registration of Class II medical devices include business license, medical device manufacturing license, quality management system certification, product registration certificate, test reports, technical data, personnel qualifications and production environment and facilities, and many other aspects. All these qualifications are set up to ensure the quality and safety of Class II medical devices, and the applicant must obtain these qualifications before applying for Class II medical device registration, and ensure the validity and compliance of these qualifications. At the same time, the national drug regulatory authorities will also strictly audit and supervise the enterprises applying for registration of Class II medical devices to ensure that the quality and safety of medical devices are guaranteed.