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In order to ensure the implementation of “Registration of IVD Reagents Administrative Decree”, National Institute Food and Drug Control (NIFDC), a national testing center authorized by CFDA, issued the third
According to a 2016 report by US Government from its export data, the best selling medical devices in China are from these product categories: In vitro diagnostic (IVD) equipment and
With economic development, aging population and people’s awareness of healthcare continues to increase, the global medical device market demand continues to grow rapidly. The medical device industry is the world’s
China’s Maccura Biotechnology formed a joint venture with Qiagen of the Netherlands to develop and market Qiagen’s GeneReader NGS system in China. Maccura is a China IVD company. It will
According to a press release, Tekni-Plex Inc. based in the US has announced a $15 million investment in a new state-of-the-art manufacturing facility in Suzhou, China. It represents the single
A recent report released by Boston Consulting Group has highlighted that medical technology is expected to break out of the emerging markets and onto the global stage. The report references
June 21, 2017 12:00 PM Eastern Daylight Time SpineGuard an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, announced today an exclusive
According a market research published by iData, China, with its 1.4 billion inhabitants, is now expected to exceed the U.S. and Japan in the telemedicine market, and the main contributing
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.
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China’s Venus Medtech acquired U.S. company InterValve to create a systematic TAVR treatment and strengthen its global expansion. Venus Medtech announced in this month that it has purchased U.S. Company
IVD China MarketChina In-vitro diagnostics market is expected to be tripling its market size by the end of 2022 from 2016, according to a new report published by Research And
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