Medical devices are divided into three categories: Category I, Category II, and Category III. We learned from Tianyan Enterprise Services that currently operating Category I products does not require a medical device business license, and operating Category II products does not require a medical device business license. Products require a Class II medical device business registration certificate, and operating Class III products requires a medical device business license. The following procedures apply for the business qualification of Class II medical devices. 1. Application processing: The drug regulatory department checks whether the application information meets the basic requirements and decides whether to accept or not accept the application; (Application processing requires filling in nearly a hundred pieces of information. If the applicant finds that any part of the information is filled in, Problems need to be returned for correction. If major non-conformities are found, they will be directly detained.) 2. On-site review: that is, the drug regulatory department assigns one to three auditors to the company's business site for review. The review method is on-site questioning assessment and on-site inspection assessment. Record the audit information and give the audit conclusion. If the requirements are not met, the company can be required to make rectifications until the rectifications meet the requirements. If the requirements are not met after rectification, a notice of disapproval will be given; (The purpose of the audit is to review the legality of the company's business site) If it is found that it is not implemented in accordance with laws, regulations, rules and regulations, the audit conclusion will directly affect whether it can pass the audit, and ultimately whether the enterprise can obtain the business license qualification) 3. Review, publicity, issuance Certificate: That is, the leader of the drug regulatory department will review and approve relevant materials to decide whether to issue a business license to the enterprise. If the company passes the review, the company's relevant information will be publicized on the relevant website. If there is no objection to the publicity, the company will be notified to obtain a medical device business license.