A class of medical devices for the record the materials required are: a copy of the business license of the enterprise, a copy of the organization code certificate, the legal person ID card, the production, quality management personnel education certificate, the main production equipment and testing devices, product risk analysis information, safety risk analysis report, product technical requirements, the product conforms to the national industry standards list.
Legal objective:"Supervision and management of medical devices business approach" Article 3 engaged in medical device business activities, should comply with the laws, regulations, rules, mandatory standards and quality management standards for medical device business requirements, to ensure that the process of medical device business information is true, accurate, complete and traceable. Medical device registrants, filers can sell their own, can also entrust the medical device business enterprises to sell their registered, filed medical devices. Article 4 of the Measures for Supervision and Administration of Medical Device Business According to the degree of risk of medical devices, medical device business implementation of classification management. The operation of Class III medical devices license management, the operation of Class II medical devices for the record management, the operation of Class I medical devices do not require licensing and filing.