"IVD" is the English abbreviation for in vitro
diagnostic products.
On the international scene, IVD, as a unique branch of
medical devices, has its unique definition and regulatory system, especially in
the United States Food and Drug Administration (FDA) and the European Union
(EC).
In vitro diagnostics are products, reagents, instruments and
systems for use in the diagnosis of the disease or other conditions, including
the determination of health status, in order to cure, mitigate, treat or
prevent disease or its aftermath. Considering that it is different in China,
which IVD is not distinguished and defined only. In other words, there is no
notion of IVD existing in China.
In China, the normal products contained in internationally
recognized IVD are divided and subordinate to medical devices (DM), in vitro
diagnostic reagents (in vitro diagnostic reagents), as well as drugs,
respectively.
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| Medical Device Designing |
In China, with the exception of two types of in vitro
diagnostic reagents for use in the detection of blood and radiolabelled sources
defined as drugs, all other IVD are medical devices (DM). Medical devices are
defined in article 3 of the Regulation on the Administration and Supervision of
medical devices published by the Council states of the Order 276 in 2000.
Medical devices are instruments, apparatus, equipment,
materials or other articles used alone or in combination, including the
software necessary for their proper functioning.
The following objectives:
1. Diagnosis, prevention, control, treatment or mitigation
of a disease;
2. The
diagnosis, monitoring, treatment, mitigation or compensation of an injury or
conditions of disability;
3. Study or
replacement or alteration of the anatomy or physiological process;
4. Design
control. In China, medical devices are classified in category I, II or III
according to the level of regulatory control that is necessary to ensure safety
and efficacy.
Class I medical devices are those for which safety and
efficacy can be ensured by routine administration;
Class II medical devices are those for which additional
control is necessary to ensure their safety and effectiveness;
Class III medical devices are those that are implanted in
the human body, or used for life or subsistence support, or present a potential
risk to the human body and therefore must be strictly controlled in terms of
safety and EF Effectiveness. However, based on actual needs, diagnostic
reagents in vitrouniquement. Stand out and define a set of provisions issued in
April 2007 were related to the manufacture, the quality system, the
registration of the product for the approval of the market and the distribution
of post-marketing control. In vitro diagnostic reagents are defined in article
3 of the in vitro diagnostic reagent management method registration effective
as of June 1, 2007. In vitro diagnostic reagents that are administered as
medical devices, Include any reagent, set, calibrator, quality control product
(substance) and so on, whether used alone or in combination with an instrument,
apparatus, equipment and system, intended for use in vitro for the examination
of specimens Humans taken from the human body (various fluids of the body,
cells and tissue samples, etc.) during observation prevention, diagnosis,
treatment and sequelae of the disease, health assessment as well as prediction
of the Hereditary disease. During this time based on product risk, in vitro
diagnostic reagents are classified in category III, II and I. In addition, some
reagents are listed in each classification as an example. Therefore, IVD in
China is subject to all of the regulatory management report requirements and
provisions, and there are no specific regulations to IVD.
However the IVD
reagents define exclusively and are subject not only to a set of MD rules, but
also its specific requirements of the regulations.
For a IVD system containing the instrument and suitable
reagents, two product registration certificates must be acquired for the
approval of the contract in accordance with the two systems and the different
and absolute regulatory procedures, The registration of medical devices for the
instrument and the recording of IVD reagents for the adapted reagents.
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