Drugs Controller General India, Central Drugs Standard Control Organizations called for a larger stakeholders consultation meeting on October 20th to discuss certain issues and suggestions for medical devices regulations in India. The agenda of the discussion was the inclusion of exemption of import license for imports of medical devices directly by hospitals. Dr. Vibhav Garg from Boston Scientific and Mr. Sudhakar Mairpady of BD represented AMCHAM in this meeting. Members discussed the issues and concerns related to the customer direct import process, accessories to be part of DMF of the main/parent equipment, concerns related to refurbished medical equipment, MSMEs fee related challenge to CDSCO, etc. It was recommended that industry submit a detailed list of challenges and recommendations including the change in management guidelines to CDSCO.


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