Medical device three qualification mainly includes the following steps:
One, prepare the information: the applicant needs to submit the information, including business license, organization code certificate, product registration certificate, quality system certification, quality management system documents, product specifications, technical information, research and development records.
Second, complete the technical research: the submitted information needs to be professional technical research, including product specifications, safety, effectiveness, reliability and so on.
Three, the completion of the audit: the audit mainly includes the business situation of the enterprise, the product's technical specifications, safety, effectiveness, reliability and so on.
Four, complete the certification: after passing the audit, the enterprise can apply for medical device level 3 qualification certification, certification is completed, the enterprise can formally obtain level 3 qualification certificate.
The above is the medical device three qualification process, the process needs to pay attention to is the preparation of information and technical research requirements are very strict, any details can not be ignored, in order to ensure that the application successfully passed.