Medical Devices must be filed/registered by the department for drug supervision and administration before they can be used for production, distribution, and use in China.

Category for Medical Devices 

Documents List


Filing/Registration Flowchart    
Class I       


Class II & III


Our Services 
1. Legal Advisory Services
(1) Legal and regulatory consultation on the Medical Device Filing/Registration System；
(2) Customized consultation on Medical Device Filing/Registration Strategies and training；
(3) Assist clients with due diligence work；
(4) intellectual property protection. 
2. Product Compliance Services
(1) Risk assessment for Filing/Registration；
(2) Application for medical device classification；
(3) Filing application；
(4) Post- Filing/Registration compliance services for production and operation activities.