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Weekly CFDA News Roundup covers policies, industry standards, guidance, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China
Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device,
Monthly CFDA News Roundup covers policies, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device,
Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device,
CFDA has issued 2 new guidelines from June 17rd to June 20th. Even though they are called guidelines, once they are released, you are expected
On June 9th, CFDA issued a technical review guideline on Optical Coherence Tomography (OTC) for comments.
The guideline is intended to guide the applicant’s preparation and writing of registration documents for Optical Coherence Tomography (OCT) ophthalmology devices. It provided a reference for the technical review department to review the registration report as well.
Currently the mainstream ophthalmology devices OCT is based on frequency domain principle. So his guideline is mainly for the OCT with the frequency domain coherent principle. For OCT with time domain coherence principle or any other principle, this guideline serves as a reference.
1. Working Principle (frequency domain OCT as the example)
The optical coherence tomography is used to measure and calculate the backscattered light from the ocular tissue by optical interference of near-infrared light, thereby generating an ocular tissue tomographic image. Optical coherence tomography uses the difference between different tissue’ ability of light reflection, absorption and scattering to create the imaging and achieve the purpose of clearly distinguishing the tissue structure.
2. Registration Unit Basis
Registration unit should be consistent with the relevant laws and regulations or guiding principles. Under normal circumstances, different model can be used as a registration unit if the only difference between them is the number of functions. OCTs with different intended use could not be used as a registration unit. OCTs with different working principles could not be used as a registration unit. For the same registration unit, the applicant should use typical model that has most complex structure, the highest indicator and the richest functions to do the test.
3. Medical Device Safety and efficacy Requirements List
Applicants could fill out the method to use to comply and provide the documents with objective evidence for compliance according to the specific situation.
If you need the English version of this list, contact us at . China Med Device, LLC, specializing in providing turn-key solution for medtech companies entry into China, brings you up to date information on CFDA.
On May 24,2017, CFDA issued the draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents”. The 2nd batch of clinical exempt class II
7 new guidelines have been released by CFDA from March 13rd to March 17th. Even though they are called guidelines, once they are released,
China is back from its >10 days national new year celebration. CFDA is busy releasing more guidelines now. Since February 10th, 2017, six have been
CFDA issued a new guideline for document preparation of innovative medical device special approval process on Dec. 15, 2016. The initial general decree that governs
I am sharing a response I posted to a question by a manufacturer RA. The Guideline was issued on Sept 21 for further feedback and