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CMD Blogs

CFDA Updates: CFDA Has Issued 2 Notice on On-site Consultation

July 27, 2017

CFDA has restricted industry from dropping in or visiting its premarket submission review staff in the 6 departments (medical devices and IVDs) prior to registration or submission of the dossier.  Industry can certainly understand the limited resources that CFDA has.  FDA has the equivalent of 700 staff with a fewer submissions.  CFDA has about 100 staff with more submissions. With so many changes in its updates and regulations, industry certainly needs clarity and onsite consultation prior to registration or submission. The current scheduled onsite consultation by each of the 6 departments certainly is a good step forward to address medtech industry’s challenges. Medtech industry in China certainly hopes to see the day when companies can interact with CFDA review staff more openly and freely. 

In addition to the onsite visit, CFDA also released online reservation system for companies to make appointments with the reviewers.

  1. Notice on “On-site Consultation on technical issues before medical devices registration”

  2. Notice on “Enabled CFDA Administration Acceptance Service Hall Online Reservation System

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CFDA Issued new guidelines on HP Antigen/Antibody Testing Regent and 3 More Medical Device/IVD for Comments

July 20, 2017

CFDA has issued 4 new guidelines from June 29rd to July 4th. Two of them are for IVD registration and the other two is for medical device. 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. The registration technical review guideline for Helicobacter Pylori (HP) Antigen / Antibody Testing Reagent for comments.
  2. The technical review guideline on HCV Genotyping Testing Reagent for comments.
  3. The clinical evaluation technical review guideline on Endometrial Removal Equipment for comments.
  4. Clinical evaluation technical review guideline on Proton/carbon Ion Treatment System
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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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