Indian medical device market regulators have published new draft in vitro diagnostic device rules and made them available for industry comment. In addition, Indian regulators have also issued updated classifications for medical devices used for rehabilitation.
The new rules would apply to any individual or company seeking to sell, supply, exhibit, promote or distribute IVDs or medical devices in India. The Central Drugs Standard Control Organization issued the draft documents intended to protect public health by monitoring the safety and efficacy of IVDs sold in India. The Drug Controller General of India updated the classification list of medical devices under the rehabilitation category…
