On June 9th, CFDA issued a technical review guideline on Optical Coherence Tomography (OTC) for comments. China Med Device, LLC, specializing in providing turn-key solution for medtech companies entry into China, brings you up to date information on CFDA. If you have any feedback, please email us at info@ChinaMedDevice.com or visit us www.ChinaMedDevice.com.
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.
Highlight of this draft:
- Working Principle (frequency domain OCT as the example)
- Registration Unit Basis
- Medical Device Safety and efficacy Requirements List
- Review Key Points
For the more detailed content, please click below:
Optical Coherence Tomography (OCT) Technical Review Guideline Draft
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------