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CMD Blogs

CFDA Update: Optical Coherence Tomography (OCT) Technical Review Guideline Draft

June 24, 2017

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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CFDA Updates: China Joins ICH

June 19, 2017

ICH Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, and Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a new Observer.

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CFDA issued the revised version of “Passive Implantable Medical Device Shelf Validity Period Registration Guideline”

June 14, 2017

On May 26th, CFDA issued a guideline of shelf validity period for passive implantable medical device.This guideline is a general requirement for passive implantable medical equipment shelf validity period and does not address other technical requirements.

The guideline is the revised version of “Passive Implantable Medical Device Shelf Life Registration Guideline” (CFDA, 2011)

Highlights of this revision:

1)     Changed “Shelf Life” to “Shelf Validity Period”

2)     Adjusted some wording

3)     Modified the definition of implanted medical equipment, consistent with the definition in “Medical Device Classification Regulation” (CFDA, No. 15).

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CFDA New Medical Device Classification Directory Will Be Released Soon

May 30, 2017

On May 11, 2017, the Standards Regulation Center in Beijing organized a meeting on how to prepare training materials for the new and pending release “Medical Device Classification Directory”. The leaders from CFDA and the Standards Regulation Center along with the responsible people for the sub-directory revised work units, more than 50 people attended the meeting. CFDA commissioner, Wang Lanming, attended the meeting and talked about the importance of thoroughly prepare the training materials for the implementation of the new Medical Device Classification Directory.

CFDA “Medical Device Classification Directory (revised) ” was issued for feedback with due date on November 25, 2016.

The revised medical device classification directory has significant implications for medical devices registrations or renewals. If your devices are not included in the revised directory, you must go through the expert panel forum to get the proper classification. Expert panel could be time-consuming and costly

This newly released revised draft directory has been in the works for the past seven years. It was finally released for industry feedback. The previous directory was released in 2002. It is very dated and lacks details and clarity. It fails to keep up with the rapid proliferation of medical devices and the growth of complex technologies that have taken place in China.

The revised directory has 22 subdirectories. It consolidated and reduced the 2002 version’s 43 subdirectories by 19. Under each of the 22 subdirectories, there are further detailed divisions. Here are a few examples of how to look at the categories.

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