The new ‘Medical Devices Rules, 2017’ have already been published and will commence w.e.f January 1st, 2018. A guidance document has been issued by the Ministry of Health & Family Welfare (MoH&FW) for the said rules under the ‘Rule 6’ after consulting medical devices & in-vitro diagnostic devices (IVD) industry […]
The new ‘Medical Devices Rules, 2017’ have already been published and will commence w.e.f January 1st, 2018. A guidance document has been issued by the Ministry of Health & Family Welfare (MoH&FW) for the said rules under the ‘Rule 6’ after consulting medical devices & in-vitro diagnostic devices (IVD) industry experts.
The guidelines will provide a rationale overview of fundamental design and manufacturing requirements to meet the principals laid down for performance and safety of both in-vitro diagnostic devices (IVD), as well as other medical devices that are to be sold in the Indian market. However, it does not dictate how manufacturers should prove that their device has met these principles. Thus, it endows manufacturers of medical devices enough flexibility to keep up with technological advances and constant development in this field.
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