How to Compile the Instruction for In Vitro Diagnostic Reagents

In vitro diagnostic reagents (IVD) are those reagents intended for use in diagnosis of disease or other conditions, including a determination of the state of health. The Guiding Principle for the Instructions of In Vitro Diagnostic Reagents has been issued on Sep 11^th, 2014, and contains the basis requirement for instruction for IVD. The instruction is the required document for IVD registration or record. The New CFDA approval process for in vitro diagnostics, please click here.

The instruction must state the following information, except in case where it is not applicable. In addition, all information must be in Chinese, and the English abbreviations with international /industrial recognition can appear in the bracket behind Chinese. If there is no proper Chinese term for the expression of IVD, it can use corresponding English or abbreviations.

××××（Common Name）Instruction

1.Product Name

Product name includes common name and English name. Common name shall be named in according with the nomenclature of Administrative Measures for the Registration of In Vitro Diagnostic Reagents. Except for the products with special use can note the sample type in common name, the rest products cannot note the sample type, qualitative/quantitative, and other contents.

2.Packing Specification

Detail the sample size or packing volumes for one unit of IVD, such as ×× preps /Kit, ××mL. Multiple reagents of IVD shall be detailed the name of each component. In addition, the article number can be added if any.

3.Intended Use

The intended use involves with two parts.
The first part shall detail the intended use (qualitative/quantitative determination, self-testing, validation, etc.), sample type, analysis, and so on. The specific expressional forms can make appropriate adjustments in according with product feature. The sample source shall be noted if the samples come from special subjects such as pregnant woman, newborn, and so on.
The second part shall detail the clinical applicability and background which are related to intended use, and explain relevant clinical diagnostic methods or laboratory diagnostic methods, and so on.

4.Inspection Mechanism

Detail the inspection mechanism and methods through texts or diagrams if necessary.

5.Main Composition

5.1For Reagents:

The name, quantity, proportion or concentration of reaction system shall be detailed; if any, the biological source, activity and other features of reagents shall be explained.
Detail whether each component of kit with different batch number can be interchange or not for multiple-reagents product.
Detail the information of consumable such as name, quantity, and so on if any.

5.2For the necessary reagents that are not provided

Detail the name and purity, the directions for mixing and dilution, and other relevant information.

5.3Calibrator and quality control

Detail the components and their biological source, calibration range and traceability of calibrator, target value range of quality control.

6.Storage Condition and Validity Term

6.1Storage condition

Detail the storage condition, such as 2～8℃, below -18℃, avoid/forbid freezing. And other conditions which can affect stability, such as: light, humidity, etc. If the stability of the products or components will be changed after opening, the storage condition of opened product should be specified.

6.2Validity term

Detail the validity term in the storage condition. If the stability of the products or components will be changed after opening, the validity term of opened product shall be specified.

6.3 If the stability of each component is different, the storage condition and validity term of each component shall be specified respectively.

7.Applied Instrument

Detail the applied instrument and its model, and provide the relevant information for operator.

8.Specimen Requirement:

Detail the sample type, special precautions, necessary additives, known interfering substances, and recommended specimen storage, handling, and shipping instructions.

9.Inspection Method

Reagent preparation: dilution, mixture and other necessary procedure.
Test condition: PH value, temperature, time and wavelength of each step, stability of final reaction product, precautions of each step, and so on.
Calibration procedure (if any): preparation and usage, and drawing method of calibration curve.
Quality control procedure: usage and quality control method.
Test result calculation or read, include explanation of every coefficient and every calculation steps. If possible, it shall be illustrated.

10.Positive Estimate Value or Reference Interval

Explain the positive estimate value or reference interval, and brief describe the determination method for those values.

11.Inspection Result Explanation

Detail the factors which may affect the inspection results, and what circumstances the validation test need be made.

12.Inspection Method Limitation

Detail the limitation of inspection method.

13.Performance Index

Detail the performance index of product.

14.Cautions

Detail the necessary cautions, such as only used for in vitro diagnosis. If the product includes human-derived or animal-origin materials, the potential infection shall be warned.

15.Marks Explanation

If there is graph or symbol in the instruction, it should explain the significance of those marks.

16.References

Note the references

17.Basic Information

For imported in vitro diagnostic reagent, the basic information as following:
Registrant (Record)/ Manufacturer Name
Address
Address of manufacturing site
Contact information
After-sales service organization Name
Contact information
Agent Name
Address
Contact information

18.Registration Serial Number/Record Number/Technical Requirement

Note the registration serial number or record number.

19.Instruction Manual Approval and Revision Date

Note the date of approval. If the instruction has applied changes, it shall note the data changed of the instruction.

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.