Clinical Evaluation

Clinical evaluation in one format or another is required for devices of all risk classes for regulatory approval by any governing body in any country. Besides the EU, the regulators from Australia, China, and India also need clinical evidence in dossier submissions. The Medical Device Regulation Act of 2020 establishes the legal foundation for the regulation of medical devices in India and also lays out the requirements for clinical evaluation. The Central Drugs Standard Control Organization (CDSCO), a division of the Ministry of Health and Family Welfare, is in charge of regulating medical devices and IVDs. This organization is known as the Drug Controller General of India (DCGI). In China, clinical evaluation is required by the National Medical Products Administration (NMPA). The U.S. FDA also requires clinical studies for 510k submissions (if not based on substantial equivalence).