NMPA issued five IVD draft guidelines on October 1, 2022, soliciting public opinions. Feedbacks need to be submitted by October 22, 2022.

Full List

• Draft guideline on research on main raw materials of in vitro diagnostic reagents
• Draft guideline on Herpes simplex virus (HSV) nucleic acid detection and typing reagents
• Draft guideline on tumor markers quantitative detection reagents
• Draft guideline on drug abuse detection reagents
• Draft guideline on Instructions for Use for in vitro diagnostic reagent

You can email us at info@ChinaMedDevice.com to leave your opinions and we will consolidate and translate it, and send to NMPA.

For the “Guideline for IVD Overseas Clinical Data Acceptance”, please click HERE

For the “Guidelines on Clinical Evaluation & Clinical Trial for IVDs”, please click HERE