Medical Device Sub-center In Yangtze River Delta Officially Launched The Review Work
2021-06-29
Recently, the Yangtze River Delta Sub-center for Medical Device Evaluation (“Yangtze River Delta Sub-center”) of the National Medical Products Administration (NMPA) officially launched the review of medical devices. As of June 18, the Yangtze River Delta Sub-center has completed 38 filing review projects and eight review projects.
In the early stage of construction, the Yangtze River Delta Sub-center, under the guidance and support of the Center for Medical Devices Evaluation (CMDE), has completed the remote docking with the electronic declaration system of the center.
Currently, the Yangtze River Delta Sub-center has begun to undertake relevant technical review tasks following the requirements of integrating work into the review system of CMDE, realizing a unified review process and standard. The acceptance items include continued registration, modification of registration, modification of license, and first registration aimed for domestic class III medical devices, imported class II and class III medical devices.
Last December, two drug and medical device evaluation and inspection subcentres were established in the Yangtze River Delta and Guangdong-Hong Kong-Macao Greater Bay Area. Delegating power to local regions expedites the national administrative examination and approval by dramatically reducing enterprise costs and promoting the transformation of pharmaceutical R & D achievements from laboratory to laboratory consumer.
Inspirative Medical suggests manufactures to follow the latest policies in the subcentres to do relevant registration. IMD can help you evaluate the gap between your products and China guidelines or standards.
