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NMPA (CFDA) New IVD Clinical Guideline: 11 Requirements You Should be Prepared for!


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.

Compared with the previous guideline, key changes are:

  1. Clinical trial sites must be on the NMPA (CFDA) filed institutions for Medical Device Clinical Trial Sites
  2. Minimum 3 clinical sites required for initial registration and 2 sites for renewal; 1 lead site must be selected whose responsibilities are specified
  3. Preliminary trial is encouraged for better clinical trial design, but cannot be combined with clinical data
  4. For IVDs without predicates approved on the market, Clinical Reference Standard (gold standard) can be used for clinical design
  5. Subgroup samples shall be enough in stratified trial
  6. Fresh samples are required instead of the stored samples
  7. Qualitative and quantitative IVD evaluation indicators are defined
  8. Third party testing labs must be designated by clinical sites instead of applicants
  9. 10-year clinical data retention for CRC; permanently stored by applicants
  10. Traceable sample with unique code; Retain until product commercialization
  11. Previous fixed sample size is replaced by statistically significant sample size. It means that each trial sample size will be different. (In the previous guideline, minimum 1000 cases required for class III and 200 cases for class II).

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.


For NMPA (CFDA) link of IVD Clinical Guideline, please email We charge nominal fee for English version.

For our webinar on How To Get IVD Approval Through CFDA, please click HERE.

Keep yourself updated with CFDA News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE.



About ChinaMed Device, LLC

ChinaMed Device, LLC (, 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.


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