CFDA has issued 4 new guidelines from June 29rd to July 4th. Two of them are for IVD registration and the other two is for medical device. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review or new submission phase. Find out how these guidelines impact your devices in China, please contact us at info@ChinaMedDevice.com.
The registration technical review guideline for Helicobacter Pylori (HP) Antigen / Antibody Testing Reagent for comments.
The technical review guideline on HCV Genotyping Testing Reagent for comments.
The clinical evaluation technical review guideline on Endometrial Removal Equipment for comments.
Clinical evaluation technical review guideline on Proton/carbon Ion Treatment System