Indian regulators, medical device associations focus on new guidelines
11-Dec-15, Regulatory Affairs Professionals Society
India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations.
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Image: RAPS
According to the minutes of the meeting, most of the discussion centered on increasing device exports and evaluating new guidance for industry.
Draft guidance on good manufacturing practices and facility requirements, known as Schedule MIII, which was originally prepared back in 2014, was re-circulated.
It was agreed that a new online database could be created to allow for basic information on manufacturers to be included to ensure “the authenticity of the manufacturer,” which would need to have at minimum some degree of quality management system compliance.