Seminar on the Implementation Opinion on Category of Medical Device Classification Held in Beijing

  • 2017-05-27

It is an important initiative for implementing the Opinion of State Council on Reformation of Examination and Approval system for Drug Medical Devices (GF[2015] No. 44) and the core content for carrying forward the reform of classification management of medical devices to overhaul the Category of Medical Device Classification (Category). The early modification of the Category of Medical Device Classification has been approved by CFDA and will be issued soon. In order to further implement the newly modified category, the Department of Medical Device Registration of CFDA organized a seminar on the Implementation Opinion on the Category of Medical Device Classification in Beijing Guangxi Plaza on May 25, 2017.

 Leaders of the Department of Medical Device Registration, Department of Medical Device Supervision, Technical Review Center and Center for Medical Device Standard Management of CFDA and relevant personnel attended the meeting and made important speeches, and the representatives of CAMDI attended the seminar in invitation. Entrusted by the CFDA, the CAMDI invited representatives of domestic and overseas, active, passive, large, medium and small enterprises, including Medtronic, Smith & Nephew, Becton Dickinson, Shinva, Beijing AEONMED, Shanghai MicroPort, Johnson&Johnson, Jingjing, and Wuhan Yuanguang, to attend the meeting. The participants delved into the implementation time of the Category and the transition of registration, production, circulation.

By this meeting, the CFDA gained insight into the suggestions and comments of the industry to the implementation of the category, which laid a good foundation for stably implementing the Category.




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