Domestic Medical Device Classification Management

Domestic medical device classification management:

The state implements the classification management of the medical devices depending on the risk levels. The evaluation of the risk levels of the medical devices shall take into consideration the intended uses, structural features, application methods and other factors of the medical devices.

Class I medical devices refer to the medical devices with low risks, whose safety and effectiveness can be ensured through routine management.

Class II medical devices refer to the medical devices with moderate risks, which shall be strictly controlled and managed to ensure their safety and effectiveness.

Class III medical devices refer to the medical devices with relatively high risks, which shall be strictly controlled and managed through special measures to ensure their safety and effectiveness.

The Class I medical devices shall be subject to product recording management, and the Class II and Class III medical devices shall be subject to product registration management.

For the recording of the domestic Class I medical devices, the recorders shall submit the recording materials to the municipal food and drug administration departments of the cities with subordinate districts.

The domestic Class II medical devices shall be reviewed by the food and drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government, and be issued with the medical device registration certificates after approval.

The domestic Class III medical devices shall be reviewed by the China Food and Drug Administration, and be issued with the medical device registration certificates after approval.

For the recording of the imported Class I medical devices, the recorders shall submit the recording materials to the China Food and Drug Administration.

The imported Class II and III medical devices shall be reviewed by the China Food and Drug Administration, and be issued with the medical device registration certificates after approval.

The medical devices shall be registered and recorded as imported medical devices in Hong Kong, Macau and Taiwan.

Classification query and identification:

For the domestic medical device declaration, the product classification shall be determined first, which can be queried mainly based on the Catalogue of Medical Device Classification (2017 Edition), and the classification definition in the system of the National Medical Device Standard Management Center. The classification level of the product in the classification catalogue or the management class defined can be searched and queried.

When the specific classification level cannot be queried for a product, such as a newly developed medical device that has not yet been included in the classification catalogue, the applicant can directly apply for the product registration in accordance with the regulations on the registration of Class III medical device products in this document, or judge the product class according to the classification rules and then apply to the China Food and Drug Administration for the classification definition in accordance with the Notice on Further Improving the Classification Definition of Medical Device Products (SYJBX [2013] No. 36), in which case the result of classification definition shall be determined by the regulatory authority after review.

Classification definition application materials:

The classification definition application materials generally include the followings:

(I) Classification definition application form;

(II) Product photos and/or product structure diagrams;

(III) Product standards and preparation instructions (if any);

(IV) Overseas marketing approval (for imported products);

(V) Other materials related to the product classification definition (such as relevant clinical literature).