CDSCO manages the affairs relating to the classification of IVD medical devices. The same department operates under the purview of the Drug Controller General of India. The Drugs & Cosmetics Act & Rule, 1949 & 1945 constitute the regulatory framework for each medical device in India. The Health Ministry of India has released the new IVD medical devices regulation to improve the effectiveness of the Drugs & Cosmetics Act 1940. In this write-up, we will discuss the classification of IVD Medical Devices.
Overview of the New Medical Devices Rules India, 2017
The new rules mitigate the requirement of periodic renewal of licenses. Accordingly, the production and import licenses shall continue to stay valid till these are suspended or revoked or surrendered. The entire licensing process shall be executed online via a dedicated online portal known as SUGAM. The said portal shall ensure seamless submission, tracking, and review of the registration documents. Regulators have already briefed out about the timeline of all the activities concerned. The Sugam portal shall also provide the facility for change in granted registration. The applicant can access this facility via “Post Approval Change”.
What are the In-Vitro Diagnostic (IVD) Medical Devices?
In- Vitro Diagnostic (IVD) medical devices are instruments, reagents and systems intended to diagnose a disease or other conditions, including to cure, determine the state of health, mitigate, treat, or prevent disease or its sequelae. These devices are intended for the preparation, collection and examination of specimens taken by the human body.
Classification of IVD Medical Devices
Under the new medical device rules, 2016 IVD (In-Vitro diagnostics) are categorized into four classes, ranging from Classes A to D, classified based on parameters described in the official Gazette released on October 17, 2016.
- Class A: Low Risk;
- Class B: Moderate Risk;
- Class C: Moderate High Risk;
- Class D: High Risk.
Class-A Classification of IVD Medical Devices
In-Vitro Diagnostic medical devices used in IVD procedures shall be assigned to Class A in case it is intended to be used as:
- A substance or an object possesses any specific characteristic its object owner intends to make suitable for an IVDs procedure related to a certain examination.
- A device specifically to be used for an IVD procedure or a variety of containers.
Class-B Classification of IVD Medical Devices
An IVDs medical device shall be assigned to Class B in case it is intended for use in:
- IVD medical devices for self-testing referred to in sub-clause (a) shall be assigned to Class B and intended to be used to get test results which are not for the determination of a medically critical status and preliminary test results that needs confirmation through the appropriate laboratory tests.
- Other IVD medical devices shall be assigned to Class B in case clauses 2(i) to 2(v) don’t apply to it or a substance or product used for the analysis of the performance of an analytical process or a part thereof without a qualitative or quantitative assigned value.
Class-C Classification of IVD Medical Devices
An IVDs medical device shall be assigned to Class C in case it is intended for use in:
- Detecting the exposure to or presence of a sexually transmitted disease.
- Detecting the presence in cerebrospinal fluid/blood of an infection agent with a risk of propagation.
- Pre-natal screening of women to determine their immune system status towards transmissible agents.
- Detecting the presence of an infectious agent, where there is a significant risk that an incorrect result will cause death/ severe disability to the individual or foetus being tested.
- Determining infective disease status or immune system status, where there is a risk that an erroneous result will lead to a patient’s management decision resulting in an imminent life-threatening situation for the patient being tested.
- Testing of human genetics.
- Screening for disease staging for selecting patients for selective therapy & management or in the diagnostic testing.
- Monitoring levels of medicinal items, biological or substance components, where there is a risk that an erroneous result will lead to a patient.
- Management decisions result in an immediate life-threatening situation for the patient being tested.
- Screening for congenital disorders in the foetus.
- Management of patients suffering from life-threatening infectious diseases.
- Blood grouping/tissue typing is subject to sub-clause (b) in case it is intended to be used for blood grouping or tissue typing or to ensure that immunological compatibility of any blood & blood component, cell, tissue, blood derivative or organ which is intended for transplantation or transfusion.
- Testing of near-patient in case it is to be used for near-patient in a blood gas analysis or a blood glucose determination.
- Self-testing devices are subject to sub-clause (b).
Class D Classification of IVS Medical Devices
IVD medical device for detecting transmissible agents shall be assigned to Class D in case it is intended to be used:
- For detecting the exposure to, or presence of, a transmissible agent;
- In any blood, blood component, cell, tissue, blood derivative or organ, as the case may be, for transplantation or transfusion or causes a life-threatening disease with a high risk of propagation.
Note: IVD medical devices for blood grouping or tissue typing referred to in sub-clause (a) shall be assigned to Class D in case it is intended to be used for blood grouping or tissue typing as per the ABO system, the Duffy system, the Kidd system, the rhesus system.
The New Classification system from the CDSCO (Central Drugs Standard Control Organization) is a forward step toward commercialization & registration of IVD (In-Vitro Diagnostics) as the Indian market of IVD is expected growth to cross billion dollars soon in India.
Read our Article:Top Differences Between Medical Devices and IVDs