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

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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
1. On June 29th, CMDE of CFDA (Center for Medical Device Evaluation, responsible for medical device registration approval under CFDA) issued  the registration technical review guideline for Helicobacter Pylori (HP) Antigen / Antibody Testing Reagent for comments.

The HP antigen / antibody testing reagent described in this guideline applies to the regent that is used in the in vitro specificity testing of the HP antigen, serum/plasma and the HP antibody in urine sample. The testing is based on colloidal gold method, enzyme-linked immunoassay and other antigen/antibody response principle.

Required registration dossier materials need to cover the following key areas:

A. Summary Materials: 1) Clinical indication background; 2) Similar product market information

B. Raw Materials Research Documents: 1) Pathogen-specific antibodies for HP antibody testing reagent; 2) Pathogen antigen for HP antibody testing reagent; 3) Other original raw materials; 4) Reagent kit quality control product; 5) Reference materials

For all the IVD CFDA registration, applicants need to buy the published national standard/reference materials that correspond to their own applying registration product from NIFDA (National Institute Food and Drug Control). To get further details about the national standard/reference material, please contact us at or view our previous blog: The Number of National Standard materials types for IVD increased from 61 to 93

C. Research Materials for main production process and reaction system: 1) Basic principle introduction; 2) Main production process; 3) Coating/Marking process research; 4) Reaction conditions determination; 5) Sample method and sample amount determination; 6) Introduction and optimum condition of color system, enzyme substrate, etc.

D. Performance Analysis Evaluation Documents: 1) Positive results detection ability; 2) Minimum detection limit (sensitivity analysis); 3) Specificity analysis; 4) Precision; 5) Hook effect

E. Positive Results Determination Criteria Documents

F. Stability Research Materials

G. Clinical Trial Materials: 1) trial method; 2) trial plan; 3) Subject population; 4) Sample type; 5) Statistical analysis.

H. Product Technical Performance Requirements

I. Registration Test

J. Instruction for Use (IFU)

Reference Regulation:

IVD Registration Management Methods (CFDA, No. 5)

Basic requirement for IVD registration dossier (2014, No.44)

If you need the English version of above regulations, please contact us at .

2. On July 6th, CMDE issued a technical review guideline on HCV Genotyping Testing Reagent for comments.
HCV genotyping reagent is used for in vitro specificity testing for different HCV genotypes in human serum and plasma. The test is based on nucleic acid detection technology including molecular bio-related method. The test target is the HCV gene sequence. Combined with clinical performance and other laboratory criteria, this reagent can be used as one of the support criteria in clinical diagnosis and treatment in Hepatitis C.
Required registration dossier materials need to cover the following areas:
  1. Summary
  2. Major Raw-material Research
  3. Research Materials for main production process and reaction system
  4. Analysis of Performance Evaluation
  5. Positive value determination criterial
  6. Stability Research
  7. Clinical Trial:
  8. Product Risk Analysis
  9. Product Technical Requirements
  10. Registration Testing
  11. IFU

For more information about IVD CFDA Registration, please check our previous blog:

1. Highlights of CFDA Draft Guidance on CER for Exempt IVD Reagents

2. China Targets Sterile Devices, Implant and IVDs for Inspection

3. The Number of National Standard materials types for IVD increased from 61 to 93

3. On June 30th, CMDE issued a clinical evaluation technical review guideline on Endometrial Removal Equipment for comments.

This guideline applies to equipment used of thermo or radiofrequency ablation to remove the endometrium caused by benign menorrhagia (excessive uterine bleeding) for women that are before menopause and have no fertility requirements.
This is a class III medical device. Clinical trial is needed for registration.

4. On July 4th, CMDE issued a clinical evaluation technical review guideline on proton/carbon ion treatment system for comments.

The guideline is on the proton/carbon ion treatment system. It belongs to the medical grade high-energy radiation equipment category under classification code 6832. The main accelerator type of the treatment system is synchrotron or cyclotron. Other similar particle beam treatment systems should refer to the relevant section of this guideline.

About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services.

FREE Situational Review: Are you exploring entry into China? Let us help you develop a strategy that optimizes your resources and objectives. Email us and check out additional resources on our website: www.ChinaMedDevice.com

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