New In Vitro Diagnostics Regulations in India

Earlier this year, India’s in vitro diagnostics (IVDs) rules of 2017 went into effect. IVDs are now classified in four classes: A, B, C, and D. The 2017 rules have a list of IVDs with their risk classification. More IVDs now require notification in India, as well as import licenses and performance evaluations to receive market approval.