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Website. cdsco .gov .in and www .cdscoonline .gov .in. The Central Drugs Standard Control Organisation ( CDSCO) is India 's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union.
The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics runs under 1945.
US$18.6 billion (2023) [1] Number of employees. 52,000 (2023) [1] Website. stryker .com. Stryker Corporation is an American multinational medical technologies corporation based in Kalamazoo, Michigan. [2] Stryker's products include implants used in joint replacement and trauma surgeries; surgical equipment and surgical navigation systems ...
A medical device company has agreed to pay $42 million and plead guilty to resolve U.S. charges that it concealed a malfunction in its lead-testing devices that resulted in thousands of children ...
Medical device reporting ( MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report ...
The Medical Device Radiocommunications Service ( MedRadio) is a specification and communication spectrum created for and set aside by the U.S. Federal Communications Commission (FCC) for the communication needs of diagnostic and therapeutic medical implants and body-worn medical devices. Devices operating on MedRadio include cardiac pacemakers ...
Substance-based medical devices encompass a varied array of products that fall under the purview of Regulation (EU) 2017/745 (MDR). Based on their intended purpose, they are classified according to rule 21 ("Devices composed of substances that are introduced via a body orifice or applied to the skin") of Annex VIII of the MDR. [2]
Medical device design in the United States. The United States medical device industry is one of the largest markets globally, exceeding $110 billion annually. In 2012 it represented 38% of the global market and more than 6500 medical device companies exist nationwide. These companies are primarily small-scale operations with fewer than 50 ...