New CFDA Guidelines on 12 Categories of Medical Devices

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New CFDA Guidelines on 12 Categories of Medical Devices

The CFDA issued 12 new guidelines on December 22nd, 2017. While they are titled guidelines, once they are officially released, you are expected to comply with them whether your products are in a review or new submission phase. Find out how these guidelines will impact your medical devices in China markets by contacting us at info@ChinaMedDevice.com for an initial consult.

1.On December 22nd, 2017, the CFDA issued a technical review guideline on an automated blood grouping analyzer.

The mechanism of an automated blood grouping analyzer is based mainly on the technologies of blood analysis and realizes an automatic design for different reaction mediums. The most common categories of automated blood grouping analyzers include test tube method, microplate method, and column agglutination method.

This guideline applies to automated blood grouping analyzers that are intended to conduct blood grouping, antibody screening, and cross-matching testing of human blood samples via test tube, microplate, and column agglutination technologies. Automated blood grouping analyzers based on other technologies may refer to the provisions of this guideline to prepare the registration application materials. Clinical analysis equipment that includes blood analysis function such as the automatic blood bank system shall refer to this guideline to prepare registration materials for its blood analysis section.

The registration application dossier includes:

A. Summary materials: 1) introduction; 2) product description; 3) registration unit and model specification; 4) scope of application

B. Research materials: 1) efficacy; 2) product life; 3) software

C. Manufacturing information: 1) manufacturing process and control; 2) manufacturing site

D. Clinical evaluation

E. Product risk analysis

F. Product technical requirements

G. Product registration testing report

H. Product instruction and the label of minimum marketing unit

2. On December 22nd, 2017, the CFDA issued a technical review guideline on ABO, RhD blood group antigen test card (column agglutination method).

ABO, RhD blood group antigen test card (column agglutination method) refers to the use of microcolumns filling with gel, glass beads, and other materials to detect the positive type of human ABO blood type and RhD antigen, which combines the principles of immunohematology, particle screening, and centrifugation.

This guideline applies to an ABO, RhD blood group test card (column agglutination method) and test card containing column agglutination method for ABO, RhD blood group antigen testing. This guideline does not apply to positive blood grouping reagents for blood screening.

The registration application dossier includes:

A. Summary: 1) intended use; 2) product description; 3) biocompatibility; 4) summary of research results; 5) evaluation of similar products in the market

B. Research information of main materials: 1) material selection, 2) preparation, 3) quality specifications

C. Research information of main manufacturing technologies and reaction systems: 1) main manufacturing technology; 2) reaction mechanism and system; 3) manufacturing process

D. Analytical performance evaluation: 1) appearance; 2) specificity; 3) sensitivity; 4) repeatability; 5) clinical sample evaluation; 6) interference evaluation; 7) validation of anticoagulant applicability

E: Positive value determination materials

F: Stability evaluation materials

G: Clinical evaluation materials: 1) research methodology; 2) site selection; 3) patient selection; 4) clinical research plan; 5) statistical analysis; 6) verification of testing discrepancy; 7) clinical data record sheets

H: Product risk analysis

I: Technology requirements

J: Report of registration testing

K: Product instruction and labeling

3. On December 22nd, 2017, the CFDA issued a technical review guideline on Human epidermal growth factor receptor 2 (HER2) gene amplification detection kit (fluorescence in situ hybridization).

This guideline applies to detection of HER2 gene amplification in tissue sections of surgically-resected specimens and biopsy specimens using fluorescence in situ hybridization (ISH), including HER2 gene average copy number (single signal) and the ratio of the average copy number of HER2 gene to the average copy number of centromere DNA sequence of chromosome 17 (CEP17) in which the gene is located (double signal).

This guideline may not be comprehensive enough for other HER2 gene amplification detection methods using ISH such as the Chromogenic ISH and Silver-enhanced ISH. Applicants may amend the non-applicable part according to their product characteristics or supplement other evaluation and verification information.

However, applicants will need to explain the reasons why this guideline is not applicable and verify the scientific rationality of the alternative method.

The registration application dossier includes:

A. Summary: 1) intended use; 2) product description; 3) similar product marketing evaluation

B. Research of main materials: 1) probe; 2) fluorochrome; 3) hybridization buffer; 4) Human Cot-1 DNA (if applicable); 5) DAPI; 6) reference product

C. Main manufacturing technology and reaction system

D. Efficacy evaluation: sensitivity; specificity; 1) accordance rate; 2) precision

E. Positive value determination

F. Stability

G. Clinical evaluation: 1) site and personnel; 2) clinical research plan; method; 3) statistical analysis; 4) verification of testing discrepancy; 5) quality control; 6) original data; 7) clinical research report

H. Product technical requirements

I. Product instructions

4. On December 22nd, 2017, the CFDA issued a technical review guideline on hepatitis C virus nucleic acid genotyping kit.

This guideline applies to HCV genotyping reagents based on the polymerase chain reaction (PCR) method. For other qualitative HCV detection methods, applicants may refer to this guideline but need to determine whether the specific content is applicable based on characteristics of their products.

The registration application dossier includes:

A. Summary

B. Main materials research information

C. Main manufacturing technology research information

D. Efficacy evaluation

E. Determination of positive value

F. Stability evaluation

G. Clinical research

H. Product risk analysis

I. Product technical requirements

J. Product registration testing report

K. Product instruction

5. On December 22nd, 2017, the CFDA issued a technical review guideline on treatment ventilators.

The intended use of a treatment ventilator is to support or maintain life. The treatment ventilator is an automatic device designed to increase or supply ventilation to a patient.

This guideline applies to a treatment ventilator that is regulated as a class III device. This guideline consists of two parts: the basic requirements for the clinical research of a treatment ventilator; and the clinical comparison of similar/predicate device.

The registration application dossier includes:

A. Basic requirements for the clinical research of a treatment ventilator: 1) the purpose and design of clinical research; 2) inclusion and exclusion criteria, procedures, evaluation index, and data analysis; 3) selection of a control product; 4) evidence of the determination of cohort size; 5) clinical trials operation and management

B. Clinical comparison of similar/predicate device: 1) working mechanism; 2) composition; 3) specifications; 4) safety evaluation; 5) national/industrial standard compliance; 6) core functions of software; 7) scope of application

6. On December 22nd, 2017, the CFDA issued a technical review guideline on the endometrium removal device (heat conduction and radiofrequency ablation).

Endometrium removal equipment is class III treatment device. This device should be used in medical institutions with corresponding medical conditions, such as clinics, hospital wards operation rooms and outpatient operation rooms. It must be operated by an obstetrician and gynecologist who has sufficient experience in uterine surgery and has been trained in the operation of endometrium removal operation.

This guideline applies to a device that removes endometrium by heat conduction or radiofrequency ablation. This type of device is designed for the removal of endometrium in premenopausal women who do not have fertility requirements and suffer from excessive menstruation caused by a benign disease (excessive uterine bleeding).

The registration application dossier includes: 

A. Basic requirements: 1) applicable clinical evaluation path; 2) device description; 3) intended use; 4) applicable parts

B. Clinical research: 1) purpose and design of clinical trials; 2) subject inclusion and exclusion criteria; 3) clinical research plan; 4) clinical research procedures; 5) evaluation index and endpoints; 6) cohort size

C. Clinical research operation and management: 1) statistical data analysis; 2) adverse events management

D. Comparison with similar or predicate devices

E. References

7. On December 22nd, 2017, the CFDA issued a technical review guideline on luteinizing hormone detection reagents (colloidal gold immunochromatography).

The guideline applies to the qualitative or semi-quantitative test of the luteinizing hormone in human urine with the principle of double antibody sandwich colloidal gold immunochromatography.

The registration application dossier includes:

A. Summary Materials: 1) intended use; 2) product description; 3) biosafety description; 4) comparison with similar or predicate devices

B. Research information of main materials (if applicable)

C. Research information of main manufacturing technologies and reaction systems (if applicable)

D. Analytical performance evaluation

E. Positive value determination materials

F. Stability evaluation materials

G. Clinical evaluation materials: 1) research methodology; 2) site selection; 3) clinical research plan; 4) patient selection; 5) statistical analysis; 6) verification of testing discrepancy

H. Product risk analysis materials

I. Product technical requirements

J. Registration testing report

K. Product instructions

8. On December 22nd, 2017, the CFDA issued a technical review guideline on cardiac troponin I, myohemoglobin, and creatine kinase isoenzyme MB detection reagents (colloidal gold immunochromatography).

This guideline applies to cardiac troponin I, myohemoglobin, and creatine kinase isoenzyme MB detection reagents (colloidal gold immunochromatography). This guideline applies to the in vitro diagnostic reagents that are based on the mechanism of antigen antibody reaction and does not apply to quantitative or semi-quantitative products.

The registration application dossier includes:

A. Summary: 1) intended use; 2) product description; 3) biosafety; 4) summary of main research outcomes and evaluation; 5) reference

B. Research information of main materials (if applicable)

C. Research information of main manufacturing technologies and reaction systems (if applicable)

D. Analytical performance evaluation1) detection limit and repeatability; 2) specificity; 3) Hook effect and sample dilution

E. Positive value determination materials

F. Stability evaluation materials

G. Clinical evaluation materials: 1) research methodology; 2) site selection; 3) ethical requirements; 4) clinical research plan; 5) patient selection; 6) statistical analysis; 7) verification of testing discrepancy; 8) clinical research final report

H. Risk analysis materials

I. Product technical requirements

J. Product registration testing report

K. Product instructions

L. Label sample

9. On December 22nd, 2017, the CFDA issued a technical review guideline on potassium, sodium, chloride, and calcium detection reagents.

This guideline applies to the potassium, sodium, and chloride detection reagents using enzymatic method and calcium detection using Arsenazo III, OCPC, and Methyl Thymol Blue methods. This guideline applies to the clinical chemical in vitro diagnostic reagents used in the quantitative detection of potassium ions, sodium ions, chloride ions, and calcium ions performed in medical laboratory using an automatic or semi-automatic analyzer or a spectrophotometer. This guideline does not apply to the detection of potassium, sodium, chloride, and calcium ions in dry electrolyte.

The registration application dossier includes:

A. Summary: 1) product intended use and clinical indications of auxiliary diagnosis; 2) product description; 3) biosafety description; 4) summary and evaluation of major research outcomes; 5) reference; 6) others

B. Research information of main materials (if applicable)

C. Research information of main manufacturing technologies and reaction systems (if applicable)

D. Analytical performance evaluation: 1) blank reagents; 2) precision; 3) specificity; 4) linear range; 5) analysis specificity; 6) analysis sensitivity; 7) others

E. Determination of reference interval

F. Stability evaluation materials

G. Clinical evaluation materials: 1) research methodology; 2) site selection; 3) clinical research plan; 4) patient selection; 5) statistical analysis; 6) verification of testing discrepancy; 7) clinical research final report

H. Product risk analysis materials

I. Product technical requirements

J. Product registration testing report

K. Product instructions

10. On December 22nd, 2017, the CFDA issued a technical review guideline on high-density lipoprotein cholesterol detection reagents.

High-density lipoprotein cholesterol detection reagents are used to determine, in vitro, the content of high-density lipoprotein cholesterol in human serum or plasma.

This guideline applies to the in vitro diagnostic reagents used for a quantitative determination of high-density lipoprotein cholesterol by an automatic or semi-automatic biochemical analyzer or spectrophotometer.

The registration application dossier includes:

A. Summary: 1) Product intended use; 2) product description; 3) biosafety description; 4) comparison with similar or predicate devices; 5) others

B. Research information of main materials (if applicable)

C. Research information of main manufacturing technologies and reaction systems (if applicable)

D. Analytical performance evaluation: 1) precision; 2) blank absorbance; 3) repeatability in batch; 4) linear range; 5) analytical sensitivity; 6) batch difference; 7) interference test; 8) traceability of calibrated products and assignment of quality control products (if applicable); 9) others

E. Determination of reference interval

F. Stability evaluation materials

G. Clinical evaluation materials: 1) research methodology; 2) site selection; 3) ethical requirements; 4) clinical research plan; 5) patient selection; 6) statistical analysis; 7) clinical research final report

H. Product risk analysis materials

I. Product technical requirements

J. Product registration testing report

K. Product instructions

11. On December 22nd, 2017, the CFDA issued a technical review guideline on cystatin C test reagent (latex transmission immunoturbidimetry).

Cystatin C test reagent (latex transmission immunoturbidimetry) is based on the principle of transmission immunoturbidimetry, which uses a semi-automatic or automatic biochemical analyzer for the in vitro quantitative analysis of cystatin C in human serum and plasma.

This guideline applies only to latex transmission immunoturbidity method and does not apply to immuno-scatter turbidimetry method.

The registration application dossier includes:

A. Summary materials: 1) product intended use and clinical indications of auxiliary diagnosis; 2) product description; 3) biosafety description; 4) summary and evaluation of major research outcomes; 5) reference; 6) others

B. Research information of main materials (if applicable)

C. Research information of main manufacturing technologies and reaction systems (if applicable)

D. Analytical performance evaluation: 1) blank reagent absorbance; 2) analytical sensitivity; 3) precision; 4) accuracy; 5) linearity; 6) analysis specificity; 7) others

E. Determination of reference intervals

F. Stability evaluation materials

G. Clinical evaluation materials: 1) research methodology; 2) site selection; 3) clinical research plan; 4) patient selection; 5) statistical analysis; 6) clinical research final report

H. Production and self-inspection records

I. Product risk analysis materials

J. Product technical requirements

K. Product registration testing report

L. Product instructions

12. On December 22nd, 2017, the CFDA issued a guideline on the development and technical review of cell therapy products.

The cell therapy products described in this guideline refers to the living cell products that are used for the treatment of human diseases, of which the source and clinical operation are in accordance with ethical requirements; and the development and registration are in accordance with drug administration regulations. This guideline does not apply to blood components used for blood transfusion, unprocessed hematopoietic stem cell transplantation, reproductive cells, and cell-composed tissues and organs products, etc. This guideline includes the sections of risk management, pharmaceutical research, pre-clinical research, and clinical research.