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Medical devices are special products related to the health and life safety of the people. According to different risks, they are divided into Class I (low risk), Class II (medium risk) and Class III (high risk). The state implements hierarchical management of medical devices. The State Drug Administration is responsible for domestic Class III and import Class II and III registration, import Class I registration, provincial drug administration is responsible for domestic Class II registration, and municipal market supervision department is responsible for domestic Class I registration. Medical devices have a wide range of products, complex technology, and a large number of relevant regulatory regulations, technical standards and guiding principles, covering a wide range. The requirements for registration and filing materials are detailed and strict. The application process and procedures vary greatly depending on the application items. For example, the special approval procedure for innovative medical devices, the priority approval procedure for medical devices, and the emergency approval procedure for medical devices have corresponding special regulations and requirements.

The company can provide the latest medical device laws and regulations consultation and training for domestic and foreign medical device enterprises; Provide guidance on the application of national standards, industrial standards and registration review guidelines for medical devices; Provide Class II and III domestic and foreign product registration and Class I product filing services, and provide consultation and guidance on the registration of innovative, priority and emergency special medical devices. The company can also provide professional solutions for clinical evaluation of medical devices, clinical trials, quality system construction and path selection from import to domestic.

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