Streamlined CFDA review process: New opportunities in China

 01-Dec-17, Brandworld Biomedical 

The Draft Amendment to Order 650 published by CFDA brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Nevertheless, there still exist some challenges for the unwary.

Image: Brandworld Biomedical

The new draft will remove the requirement to have regulatory approval in the country of origin for technologies which are not currently available in China. 

However, the provision of more freedom does not mean CFDA is lowering the bar of approval. Manufacturers must still establish a Chinese Product Technical Requirement. 

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