Blog

July 5, 2017

CFDA Updates: Priorities of CFDA 2017 Reform Related to Medical Device, MedTech, IVD

    In a press conference held earlier this year by CFDA, the agency declared that it would be pursuing its reform of the drug and medical device approval system […]
July 5, 2017

China and Other Emerging Medtech Markets Ready for Global Stage

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 […]
July 3, 2017

CFDA Update: Protecting Medical Device Data Confidentiality in China

Among the most asked questions from medical device makers who are conducting business in China is how the CFDA guarantees that data stays private and safe. To help ease the […]
July 3, 2017

CFDA Update: New guidelines on Disposable Infusion Pump and Blood Storage Bag

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 to comply with them whether your products are in the review or new submission phase. Find out how these guidelines impact your devices in China, please contact us at info@ChinaMedDevice.com.

1.   On June 20th, CFDA issued a technical review guideline on Disposable Infusion Pump (Non-electric Driven) for comments. 

It is class III with class code 6866.

The Disposable Infusion Pump (Non-electric Driven) is a medical device used in medical institutions. It injects drugs or biologics into the human body in a controlled pumping mechanism

This guideline does not apply to electric powered or electric-controlled infusion pumps, implanted drug infusion device, enteral nutrition infusion pump, percutaneous infusion devices. The guideline applies to the infusion devices that are controlled and powered by patients direct intervention instead of the devices that are powered and controlled by themselves.

June 29, 2017

CFDA Approves Novel Heart Valve Replacement Device

China’s Food and Drug Administration has approved a new-generation heart valve replacement product, which greatly reduces surgery time and increases survival rate.   The J-Valve, an upgraded transcatheter aortic valve […]
June 27, 2017

SpineGuard and XinRong Medical Group Sign Exclusive Distribution Agreement For PediGuard® in China

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 […]
June 27, 2017

China Market Report: China On The Way To Become The Largest Telehealth Market

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 […]
June 24, 2017

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

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.

June 23, 2017

Why This Chinese Fund Is Seeking Medical Device Investment Opportunities

“We are more interested in investing in innovative medical devices, which has a greater chance of finding value in companies making ‘small and beautiful’ products.” Ke Zhang, a Tronfund partner […]
June 23, 2017

Market Analysis: China’s Cardiovascular Device Market

As the No. 1 cause of death worldwide, mortality from cardiovascular disease in China is also increasing significantly. In Beijing, for example, the total loss of cardiovascular disease life expectancy […]
June 21, 2017

China Market Flash: Venus Medtech Acquires InterValve

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 […]
June 19, 2017

CFDA Updates: China Joins ICH

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. The International Council for Harmonisation […]