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Parameters For Classification Of Medical And In-vitro Diagnostic Medical Devices For Registration
The Medical Device Rules, 2017 have been formulated by the Central Government to provide a reliable platform for the sale and use of medical devices in India. The medical device regulations in India classify these devices on the basis of certain factors. Which are useful for the registration process and provide a clear framework for manufacturers and important to file an application.
The parameters for classification of medical devices have been defined in the first schedule of the Medical Device Rules, 2017. Which is further classified into parts 1 and 2 to define medical devices and in-vitro diagnostics.
Parameters for the classification of medical devices
A total of 18 parameters have been defined to classify medical devices. Which further differentiate among devices and classify them to different risk categories. These are:
1. Non-invasive medical devices that come into contact with injured skin.
2. Non-invasive medical devices for channeling or storing substances(ex, blood bags)
3. Non-invasive medical devices for modifying compositions of substances.
4. Other non-invasive medical devices(which don’t apply to parameters 1, 2 or 3 above)
5. Invasive (body orifice) medical devices for transient use.
6. Invasive (body orifice) medical devices for short term use.
7. Invasive (body orifice) medical devices for long term use.
8. Invasive (body orifice) medical devices for connection to active medical devices.
9. Surgically invasive medical devices for transient use.
10. Surgically invasive medical devices for short term use.
11. Implantable medical devices and surgically invasive medical devices for long term use.
12. Active therapeutic medical devices for administering or exchanging energy.
13. Active diagnostic medical devices.
14. Other active medical devices.
15. Devices incorporating medicinal products.
16. Devices incorporating animal or human cells, tissues or derivatives.
17. Medical devices for sterilization or disinfection.
18. Medical devices for contraceptive use.
The parameters for the classification of in-vitro diagnostic devices have been defined in Part II of these rules. These include:
1. In vitro diagnostic medical devices for detecting transmissible agents, etc.
2. In vitro diagnostic medical devices for blood grouping or tissue typing.
3. In vitro diagnostic medical devices for self-testing.
4. In vitro diagnostic medical devices for near-patient testing.
5. In vitro diagnostic medical devices used in in vitro diagnostic procedures.
6. Other in-vitro diagnostic medical devices.
If several rules apply to the same device. The strictest rules resulting in higher classification will apply. Moreover, if a device has to be used in combination with another device, individual classification rules for each device shall apply.
The classification parameters make it easy for the registering authorities as well as the applicant to initiate the registration process. This comprehensive set of parameters serves as a viable guide to plan for medical device manufacture or import process.
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