What are the key requirements for obtaining a medical device license in India?
To obtain a medical device license in India, key requirements include submitting a detailed application to the Central Drugs Standard Control Organization (CDSCO), providing product specifications, manufacturing details, clinical data, and ISO certifications. Applicants must also ensure compliance with Medical Device Rules, 2017, and submit proof of quality management systems. Regulatory fees and labeling requirements must also be fulfilled.
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Healthcare Statistical Analysis System
iFour Technolab developed an automated web-based solution for a healthcare and life-science brand to facilitate the diagnosis and treatment of acute appendicitis. The system provides a comprehensive cost-benefit analysis through predictive statistical models, comparing new medical methods against existing practices. Read More....
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