I. Purpose of Compilation
The comparison of the same variety of in vitro diagnostic
reagents in this Guidelines refers to: for in vitro diagnostic
reagents that are exempt from clinical trials, the applicant will
make a methodological comparison between the in vitro
diagnostic reagent for testing and a product of the same variety
marketed in China under the background of non-clinical trials to
prove that in vitro diagnostic reagent for testing is essentially the
same as the marketed product.
The purpose of the guideline is to provide technical guidance for
the applicants to compare in vitro diagnostic reagents that are
exempted from clinical trials with the same variety of products,
and to provide a basis for the technical review of this part of the
data by the drug regulatory authorities.
II. Legal Basis
(i) Regulations for the Supervision and Administration of Medical
Devices.
(ii) Provisions for In Vitro Diagnostic Reagent Registration.
III. Scope of Application
This Guidelines is applicable to the comparative study on Class II
and Class III in vitro diagnostic reagents which are exempted
from clinical trials and the same variety of marketed products.
For in vitro diagnostic reagents that are exempted from clinical
trials, the applicant shall submit the basis for determining the
exemption of the reagent from clinical trial.
For in vitro diagnostic reagents that are exempted from clinical
trials, the applicant can conduct a comparative study on the in
vitro diagnostic reagent and a product of the same variety
according to the requirements of this Guidelines, or conduct a
clinical trial according to the requirements of the Guideline for
Clinical Trials of In-vitro Diagnostic Reagents.
IV. Basic Principles
For Class II and Class III in vitro diagnostic reagents which are
exempted from clinical trials, the applicant can compare the in
vitro diagnostic reagent for testing with the product of the same
variety marketed in China to prove that the in vitro diagnostic
reagent for testing is essentially the same as the marketed
product.
The applicant should have completed all other performance
evaluations of the in vitro diagnostic reagent for testing before
conducting the comparative study, and have a full understanding
of the performance of the in vitro diagnostic reagent for testing,
so as to provide a basis for the comparison of the in vitro
diagnostic reagent for testing with the marketed product of the
same variety.
If the comparative study fails to prove the in vitro diagnostic
reagent for testing is essentially the same as the marketed
product of the same variety, the in vitro diagnostic reagent for
testing should be evaluated in the form of clinical trial.
V. Specific Requirements for Comparative Study
(i) Selection of contrast reagents
For in vitro diagnostic reagents that are exempted from clinical
trials, if the method described in this Guidelines is used to make
the comparative study, the domestically marketed products
commensurate with the in vitro diagnostic reagent for testing
should be determined as the comparative reagent by
comparative analysis.
The applicant should first compare the intended use between
the in vitro diagnostic reagent and the product of the same
variety already marketed in China.Intended use refers to the
general use or function of an in vitro diagnostic reagent,
including sample type, object to be tested and
indications.Indications refer to diseases or conditions that are
diagnosed, prevented, predicted, monitored for treatment or
observed for prognosis by in vitro diagnostic reagents, including
the applicable population.If the intended use of the in vitro
diagnostic reagent for testing falls within the scope of the
intended use of a product already marketed in China, the two are
considered to have the same intended use.If there are functional
differences between the in vitro diagnostic reagent for testing
and the product marketed in China (e.g. for auxiliary diagnosis
and treatment monitoring respectively), and applicable
population differences (e.g. for adults and children respectively),
it is considered that they have different intended uses.
On the premise that the in vitro diagnostic reagent for testing has
the same intended use of the product marketed in China, the
applicant should continue to make a comparative analysis of the
basic principles, main components, performance indicators,
positive judgment values or reference intervals and testing
methods between them.If there are differences, the applicant
should further assess whether the differences will have a
significant impact on their performance in testing human
samples.If the differences between them do not have a
significant impact on their performance in testing human
samples, they are considered comparable.If the basic principles
(methodologies) of the two are quite different from each other
(such as chemiluminescence and immunoturbidimetry) or their
performance indicators are quite different, they are considered
uncomparable.
The product of the same variety marketed in China can be used
as contrast reagent when it meets the following conditions at the
same time:
- Approved to be marketed in China;
- It has the same intended use as the in vitro diagnostic reagent
used for testing; - The differences between it and the in vitro diagnostic reagent
for testing will not have a significant impact on their
performance in testing human samples; - It has good clinical applications, and its product quality is good
based on the existing technology level; - For quantitative reagents, the testing results of the contrast
reagent and the in vitro diagnostic reagent for testing should
have the same unit of measurement or the unit of measurement
between them can be converted into each other.
(ii) Testing site
The applicant may complete the trial independently or
commission other competent laboratories to complete the trial
according to the characteristics of the product.
The trial process is managed by the applicant, and the applicant
should be responsible for the authenticity, reliability and
integrity of the trial data. Overseas applicants shall conduct trials
in China through their agents in China.
(iii) Testing personnel
The trial operator shall be a professional and technical person
with corresponding trial ability and be familiar with the testing
process of the in vitro diagnostic reagent for testing and the
contrast reagent.
