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CFDA ( China Food and Drug Administration)

Registration and Recordation For Medical devices Class I and II and III

Class I Medical Devices

Are those for which safety and effectiveness can be ensured through routine administration.

The medical devices of Class I shall be subject to the product recording and administration.

Any overseas production enterprises exporting the medical devices in Class I to the territory of China, or to their representative offices or enterprises established within the territory of China, shall submit to the food and drug supervision and administration department of the State Council relevant documentation. The documents must prove certifying and the approval for the marketing of such medical devices confirmed by the competent departments in the countries or regions where the different parties representing the medical devices are located.

Class II Medical Devices

Means the medical devices with moderate risks, which shall be strictly controlled and administered to ensure their safety and effectiveness.

Class III Medical Devices

Means the medical devices with relatively high risks, which shall be strictly controlled and administered through special measures to ensure their safety and effectiveness.

The medical devices Class II and Class III shall be subject to the product registration and administration.
Any overseas production enterprises exporting the medical devices of Class II and III to the territory of China, or the representative offices established by them within the territory of China, shall submit to the food and drug supervision and administration department of the State Council the registration application materials and the documents certifying the approval of the marketing of such medical devices by the competent departments in the countries (regions) where the registration applicants are located.

Documented procedures must take place such as application for medical devise; inspection by China Food and Drug Administration (CFDA) for acceptance, review and decision and conformation for delivery; technical review by CMDE (China Medical Devise Evaluation).
Procedures must be taken into account such as appointment of a legal responsible agent in China, registration of medical devise; preparing technical files, sample testing; if required clinical trials; technical review by China Medical Devise Evaluation(CMDE); administrative and technical file approval; registration and issuing of certificate; if required proof of quality system.

CE medical with offices in China can manage the complete certification process and requires procedures for registration in China.

Legistration and Recordation

The medical devices of Class I shall be subject to the product recordation administration.
Where any overseas production enterprises export the medical devices of Class I to the territory of China, the representative offices established by them within the territory of China or the incorporated enterprises within the territory of China designed by them as agents shall submit to the food and drug supervision and administration department of the State Council the recordation materials and the documents certifying the approval of the marketing of such medical devices by the competent departments in the countries (regions) where the parties undergoing recordation of medical devices are located.

 

Do you have any questions about CFDA? Don’t hesitate to contact us, we are happy to help you.