The Indian government’s intention for many years to oversee registration of medical devices in India with a developed regulatory structure which is still not materialized but there were a number of steps taken to move the medical device registration to a substantial one. To look after the growing medical device market and its regulations, the government of India has proposed for the National Medical Devices Authority (NMDA). READ ALSO: Important Licenses and Forms to Keep in Mind: CDSCO
The responsibility of the NMDA would be to ensure safety and effectiveness of the medical devices in the country. It would also look after the selling price levels of medical devices and manufacturing domestically in India. READ ALSO: Documents Required for Manufacturing License in India. Only 22 notified medical devices are currently regulated with the requirement of regulatory approval one of the GHTF countries (United States, Canada, Europe, Japan, or Australia) under the Ministry of Health and Family Welfare and the Central Drugs Standard Control Organization (CDSCO). This measure to a stringent regulatory system would increase the transparency and also the manufacturers interest to enter Indian market.
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