Medical Device Registration

Service Introduction:

Classification definition:

Clear classification will help determine the registration method, application objects, and work budget. The review and supervision of products by most national drug regulatory departments belongs to classified management. In China, for medical device products that cannot be independently determined by enterprises and require the ability to apply for category confirmation, enterprises can apply, review, and provide feedback on the results online.

Registration Unit:

The registration unit determines the number of registration certificates. Different registration units usually do not have the same certificate. Enterprises can divide the registration units themselves or entrust Erico to evaluate the division of registration units. Usually, medical device registration units are divided according to the classification of active, passive, and in vitro diagnostic medical devices based on factors such as the product's scope of application, technical principles, structural composition, performance indicators, main raw materials, and packaging specifications of in vitro diagnostic reagents.

The Class I category is medical devices with a low level of risk that can be safely and effectively managed through routine management. Domestic production enterprises need to register with the local drug regulatory bureau, while overseas medical device production enterprises need to entrust domestic agents to register with NMPA.

TThe Class II category is medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness. Domestic production enterprises need to register with the provincial (municipal) drug regulatory bureau where they are located, and overseas medical device production enterprises need to entrust domestic agents to register with NMPA.

The Class III category is medical devices that have high risks and require special measures to strictly control and manage them to ensure their safety and effectiveness. Both domestic and foreign medical device manufacturers need to register with NMPA.

Service content:

Introduction to the registration process: