The Indian Ministry of Health and Family Welfare published a draft of Medical Device Rules, 2016 which are classified medium to high risk IVD devices under the new ivd classification system will require CDSCO (Central Drugs Standard Control Organization) registration certificate or license.
The current regulations has only 23 types of medical devices and IVD require registration and so this regulatory draft represents a significant change to the regulatory requirements for most medical device manufactures selling or intending to sell in India.
Currently In-Vitro Diagnostic devices for HIV, HBV, HCV & Blood grouping sera are notified under Drugs & Cosmetics act 1940 and IVD Kits /Reagents excluding those would be covered under the category of Non – notified IVD Products. At present IVD’s are not assigned any classification system by the CDSCO. The current IVD registration process has three key licenses required to sell IVDs in India.
IVD Classification System:
Under the new medical device rules, 2016, In – Vitro diagnostics (IVD’s) are categorized into 4 groups, ranging from Class A to Class D, classified on the basis of parameters described in the official Gazette released on 17 Oct, 2016. Low risk – Class A, Low moderate risk – Class B, Moderate High risk –Class C, High risk – Class D.
This new proposal for IVD classification system of CDSCO is more likely to be implemented quickly.
- If the device is intended to be used in combination with another device then the classification rules shall apply separately to each of the devices.
- Software which operates a device or influences the use of a device falls automatically in the same class.
- Standalone software which are not incorporated into the medical device itself and provide an analysis based on the results from the analyser shall be classified in to the same category that of the IVD where it controls or influences the intended output of a separate IVD.
- Subject to the clause (c) and (d), software that is not incorporated in an IVD shall be classified using the classification provisions as specified in clause 2.
- Calibrators intended to be used with a reagent should be treated in the same class as the IVD medical device reagent.
Class A In-vitro Diagnostic Medical Devices:
In-vitro diagnostic products used in-vitro diagnostic procedures shall be assigned to Class A if it is intended to be used as,
- a reagent or an article which possesses any specific characteristic that is intended by its product owner to make it suitable for an IVD procedure related to a specific examination
- an instrument specifically to be used for an IVD procedure or a specimen receptacle.
Class B In-vitro Diagnostic Medical Devices:
- IVD products for self-testing referred to in sub-clause (a) shall be assigned to Class B if it is intended to be used to obtain test results that are not for the determination of a medically critical status or preliminary test results which require confirmation by appropriate laboratory tests.
- Other IVD products shall be assigned to Class B If clauses (2)(i) to (2)(v) do not apply to it or a substance or device used for the analysis of the performance of an analytical procedure or a part thereof without a quantitative or qualitative assigned value.
Class C In-vitro Diagnostic Medical Devices:
An IVD medical device shall be assigned to Class C, if it is intended for use in,-
- Detecting the presence of/ exposure to a sexually transmitted agent
- Detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation
- Detecting the presence of an infectious agent, where there is a significant risk that an erroneous result will cause death or severe disability to the individual or foetus being tested
- Pre-natal screening of women in order to determine their immune status towards transmissible agents.
- Determining infective disease status or immune status, where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient being tested.
- Screening for disease staging for the selection of patients for selective therapy and management or in the diagnosis of cancer
- Human genetic testing
- Monitoring levels of medicinal products, substances or biological components, where there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening situation for the patient being tested.
- Management of patients suffering from a life-threatening infectious disease.
- Screening for congenital disorders in the foetus
- Blood grouping or tissue typing is subject to sub-clause (b) if it is intended to be used for blood grouping or tissue typing to ensure the immunological compatibility of any blood, blood component, blood derivative, cell, tissue or organ that is intended for transfusion or transplantation.
- self-testing products subject to sub-clause (b)
- Near-patient testing if it is to be used for near-patient testing in a blood gas analysis or a blood glucose determination.
Class D In-vitro Diagnostic Medical Devices:
In-vitro diagnostic products for detecting transmissible agents shall be assigned to Class D if it is intended to be used
- for detecting the presence of, or exposure to, a transmissible agent that,
- in any blood, blood component, blood derivative, cell, tissue or organ, in order to assess the suitability of the blood, blood component, blood derivative, cell, tissue or organ, as the case may be, for transfusion or transplantation or Causes a life-threatening disease with a high risk of propagation
IVD products for blood grouping or tissue typing referred to in sub-clause (a) shall be assigned to Class D, if it is intended
- to be used for blood grouping or tissue typing according to the ABO system, the, the Duffy system, the Kell system, the Kidd system, the rhesus system
This new classification system by the Central Drugs Standard Control Organization (CDSCO) is a forward step towards registration and commercialization of In-vitro Diagnostics (IVD’s) as the Indian IVD market is expected growth to cross billion dollar soon in India. The other articles on the Indian medical device rules, 2016 o and the classification system followed is below,
- India: Medical Device Rules, 2016
- Medical Device Classification System, 2016
- Forms and Purposes under the Medical Device Rules in India
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