In view of the new Medical Device Rules 2017 entry into force, two measures were recently approved in India relating to:
- the list of Medical Devices and IVDs subject to registration; and
- a list of essential requirements applicable to all Medical Devices and IVDs.
Starting January 2018, manufacturers of devices included in the list issued by CDSCO and intending to market in India shall register their products with the competent Authorities. It is expected that this list will be further extended to other Medical Devices and IVDs and organized in subclasses in accordance with Medical Device Rules 2017.
As regards the essential requirements list, the CDSCO defined seven requirements that will be applicable to all devices. These requirements regulate Medical Devices and IVDs manufacture, design and packaging in order to ensure patient safety, reduce end-user risks, and optimize the benefits provided by the device use. In addition, as of January 2018, manufacturers will have to keep and submit at any time to the CDSCO the documentation attesting their devices compliance with the above-mentioned requirements.
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