Ablation Devices Now Require Registration in India

The India Ministry of Health and Family Welfare has just added ‘ablation devices’ to the list of notified medical device which require a Registration Certificate to be imported into India. The change was announced on January 25, 2016 to take effect immediately.

The registration process for medical devices in India requires ISO 13485 certification from the legal manufacturer and home country and/or reference country approval. Applications are processed by the Central Drugs Standard Control Office (CDSCO) in 9 to 11 months. Current processing fees are US$1,500 per Plant Master File and US$1,000 per Device Master File. These fees were to be increased to US$10,000 and US$5,000 respectively on February 29, but the change has not yet been implemented.

Contact Asia Actual to register medical devices in India.