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Medical Test Lab




Medical devices include all the health technologies (except for vaccines and medicines) required for prevention, diagnosis, treatment, monitoring, rehabilitation, and palliation. They are indispensable for universal health coverage, monitoring well-being, and addressing outbreaks or emergencies. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body responsible for the approval, registration, and regulation of drugs, medical devices, and other health-related products in India. Any product that falls under the purview of CDSCO requires registration, which involves a series of rigorous evaluations and assessments to ensure safety, efficacy, and quality. 


CDSCO Certification



Medical device CDSCO certification refers to the process by which medical devices and IVDs are evaluated and approved for use in India. The certification process involves a thorough review of the device’s design, manufacturing processes, and performance data. Once a medical device receives CDSCO certification, it is allowed to be marketed and sold in India. The certification is critical for ensuring that medical devices used in India meet the highest standards of safety and quality.

As per government rules, a medical device that itself or its predicate hasn’t yet been included in the medical devices list of CDSCO (Central Drugs Standard Control Organization) is considered a new medical device. Moreover, already registered devices vying to apply for new claims with respect to different implementation factors will also be treated as new devices.