The NMPA issued five IVD draft guidelines on October 1, 2022, soliciting public opinions. Feedbacks need to be submitted by October 22, 2022.
Full List of 5 IVD Draft Guidelines
- 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 the NMPA.
View the “Guideline for IVD Overseas Clinical Data Acceptance”
View the “Guidelines on Clinical Evaluation & Clinical Trial for IVDs”
About China Med Device, LLC
China Med Device, LLC (chinameddevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.
Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trials, IVD draft guidelines, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.