Medical devices play an immensely important role in patient care by enabling effective diagnosis, monitoring, and treatment of many medical conditions. Medical devices are classified into various types on the basis of risk associated with their use. In India, medical devices are classified into four categories, whereas in the United States, it has been classified into three categories. Realizing the significance of safe and effective use of medical devices, regulatory agencies around the world have formulated suitable guidelines for their import as well as their manufacturing. Post-marketing surveillance of medical devices has also been initiated in many countries to avoid any untoward events during the use of medical devices. Union government of India has initiated Materiovigilance Program of India (MvPI) to track the adverse events associated with the use of medical devices, to generate safety data, create awareness among the different stakeholders, and recommend the best practices and interventions to improve the patient's safety.

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Medical Device and Medical Device Regulations

  • Bikash Ranjan Meher,
  • Vishnoukumaar Sivaji

摘要

Medical devices play an immensely important role in patient care by enabling effective diagnosis, monitoring, and treatment of many medical conditions. Medical devices are classified into various types on the basis of risk associated with their use. In India, medical devices are classified into four categories, whereas in the United States, it has been classified into three categories. Realizing the significance of safe and effective use of medical devices, regulatory agencies around the world have formulated suitable guidelines for their import as well as their manufacturing. Post-marketing surveillance of medical devices has also been initiated in many countries to avoid any untoward events during the use of medical devices. Union government of India has initiated Materiovigilance Program of India (MvPI) to track the adverse events associated with the use of medical devices, to generate safety data, create awareness among the different stakeholders, and recommend the best practices and interventions to improve the patient's safety.