NMPA (CFDA) published draft IVD Clinical Trial Guideline for feedback on November 22nd, 2018 during the U.S. Thanksgiving holiday. After initial clinical guideline issued in September 2014, NMPA (CFDA) has spent several years to learn the best practice of international IVD clinical requirements and try to standardize the IVD clinical process.
Whether you are renewing or applying for new registration, your IVD(s) will need to meet the new guideline once it is implemented (expected in 2019). Currently the guideline is a feedback draft. Please let us know if you would like to submit any feedback to NMPA (CFDA).
ChinaMed Device, LLC has onsite staff to help you assess and expedite your clinical trial needs to shorten your renewal or new approval time. info@ChinaMedDevice.com.
Compared with the previous guideline, key changes are:
These are some of the key changes. The changes will likely to increase clinical trial costs significantly due to requirement of fresh samples and statistically significant sampling size.
Feedbacks need to be submitted by December 31st, 2018. ChinaMed Device, LLC has onsite staff to help you assess and expedite your clinical trial needs to shorten your renewal or new approval time. info@ChinaMedDevice.com.
For NMPA (CFDA) link of IVD Clinical Guideline, please email info@ChinaMedDevice.com. We charge nominal fee for English version.
For our webinar on How To Get IVD Approval Through CFDA, please click HERE.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation report (CER), clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, and distribution qualification. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.