CFDA issued 5 Technical Review Guidelines on Sept.25, 2017. Including "ELIASA Registration Technical Review Guideline", "Disposable Electrode Registration Technical Review Guideline", "Ambulatory Blood Pressure Monitor Registration Technical Review Guideline", "ECG Registration Technical Review Guideline(2017 Revision) " and "Patient Monitor (Class II) Registration Technical Review Guideline (2017 Revision)".
The Guidelines consist of 3 Key Parts, (1) Intended Use, (2) Technical Review Critical Points including Product Name, Structure and Composition, Working Principle, Principle and examples of Unit Partitioning, Relevant Standards, Indication for Use and Contraindication, Risk Analysis Data, Product Technical Requirement, Typical Unit Definition, Manufacturing Information, Clinical Evaluation Report, Adverse Events and Chinese Manual and Label requirements, (3) Review Concerns or Issues.
All the above 5 products belong to Class II Medical Device, the guidelines are not mandatory, there is no administrative approval requirements, however, CFDA reviewers should pay close attention to relevant laws and regulations to verify that the declared product meets the regulatory requirements. It will help the applicants to prepare the documents with clear requirements for CFDA submission.
If you are interested in these CFDA Guidelines related topics with more detailed information, please feel free to contact me at julianiu@ramed.top.
Ramed Bioscience provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.