Training details section

Indian Medical Device Regulations & Risk Management

Risk management in medical devices is a crucial aspect of ensuring patient safety and compliance with regulatory requirements.

Indian Medical Device Regulations & Risk Management

In India, the regulation and oversight of medical devices are primarily governed by the Central Drugs Standard Control Organization (CDSCO), which is the national regulatory authority for drugs and medical devices.

The CDSCO is responsible for ensuring the safety, quality, and efficacy of medical devices available in the Indian market.


Here are the key aspects of risk management and regulation of medical devices in India:

  • Classification of Medical Devices
  • Medical Device Rules (MDR)
  • Medical Device Registration
  • Quality Management System (QMS
  • Risk Classification and Assessment
  • Post-Market Surveillance
  • Labelling and Packaging
  • Clinical Trials
  • Import and Export
  • Collaboration with International Standards

By actively managing risks, complying with regulations, and promoting a culture of safety, healthcare organizations can effectively navigate the complex regulatory landscape and deliver high-quality care to patients.