Regulatory Open Forum

Shanghai CFDA released "Notice on Further Strengthening the Supervision and Management of Medical Device Supply Enterprises" on Oct.11, 2017, one of the most important issue is to further strengthen Imported Medical Device Label and Manual's supervision.

Based on "Regulation for the Supervision and Administration of Medical Device" and "Regulation for the User Manual and Label of Medical Device", all the imported medical device that are distributed or used in China should have Chinese User Manual and Chinese Label. Local Medical Device Distribution Enterprises could not be engaged in Labeling and other production and processing activities. Local CFDA should order the Enterprises stop selling or using the products once they find the Chinese User Manual and Chinese Label are not in accordance with CFDA related regulations, and report to Shanghai CFDA. Meanwhile, they will pay close attention to the source of Imported Medical Device, if they find the abnormal Chinese User Manual and Label or add Chinese Label without authorization from the Distribution Enterprises, Shanghai CFDA will do thorough investigation, trace the source, and strictly investigate and punish once they find illegal behaviors.

All the information in the User Manual and Label should be in accordance with CFDA Certificate, including CFDA Certificate Number, Product Technical Requirement Number, Product Name, Product Model, Manufacturer's Name, Manufacturer's Address, Manufacturer's Contact Information, Agent and After-sale Service Name, Agent and After-sale Service Address, Expected Service Life (if has), Electrical Rating Information (Voltage, Frequency and Power)  (if has) and other required information from product characteristics.

I hope the above information will help you to understand the updated requirements Chinese Label and Manual from CFDA perspective will be more and more strictly, please pay more attention to Manual and Label issues.

Please feel free to contact me if you have any questions for Chinese User Manual or Chinese Label issues with julianiu@ramed.top.

Ramed Bioscience provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.

Shanghai CFDA released "Notice on Further Strengthening the Supervision and Management of Medical Device Supply Enterprises" on Oct.11, 2017, one of the most important issue is to further strengthen Imported Medical Device Label and Manual's supervision.

Based on "Regulation for the Supervision and Administration of Medical Device" and "Regulation for the User Manual and Label of Medical Device", all the imported medical device that are distributed or used in China should have Chinese User Manual and Chinese Label. Local Medical Device Distribution Enterprises could not be engaged in Labeling and other production and processing activities. Local CFDA should order the Enterprises stop selling or using the products once they find the Chinese User Manual and Chinese Label are not in accordance with CFDA related regulations, and report to Shanghai CFDA. Meanwhile, they will pay close attention to the source of Imported Medical Device, if they find the abnormal Chinese User Manual and Label or add Chinese Label without authorization from the Distribution Enterprises, Shanghai CFDA will do thorough investigation, trace the source, and strictly investigate and punish once they find illegal behaviors.

All the information in the User Manual and Label should be in accordance with CFDA Certificate, including CFDA Certificate Number, Product Technical Requirement Number, Product Name, Product Model, Manufacturer's Name, Manufacturer's Address, Manufacturer's Contact Information, Agent and After-sale Service Name, Agent and After-sale Service Address, Expected Service Life (if has), Electrical Rating Information (Voltage, Frequency and Power)  (if has) and other required information from product characteristics.

I hope the above information will help you to understand the updated requirements Chinese Label and Manual from CFDA perspective will be more and more strictly, please pay more attention to Manual and Label issues.

Please feel free to contact me if you have any questions for Chinese User Manual or Chinese Label issues with julianiu@ramed.top.

Ramed Bioscience provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.