Indian Medical Device Regulation Changes in 2015?

India’s health ministry, the Department of Health and Family Welfare, will submit proposed changes to the country’s medical device and pharmaceutical laws to Parliament in 2015.

Medical device regulatory reform in India coming in 2015?The proposed Drugs and Cosmetics (Amendment) Bill, 2015 would adopt definitions of medical devices as well as in vitro diagnostic (IVD) products more in line with that established by the European Medical Device Directives, and would establish more explicit and systemized requirements for device importation, manufacturing, sales and distribution. More detailed and thorough regulatory requirements for clinical trials involving medical devices are also included in the proposed law.

In addition, the law would create a Medical Devices Technical Advisory Board to consult with central and state Indian governments regarding technical and administrative issues.

News of the proposed amendments to India’s medical device regulations coincides with the Central Drugs Standards Control Organization’s (CDSCO) announcement of the agency’s regulatory initiatives for 2015, including:

  • Revised Good Manufacturing Practice quality management system standards based more fully on international standards
  • Finalized accreditation standards for clinical trials, ethics committees and investigators
  • Implementation of a system for online submission of clinical trial applications for both drugs and medical devices

Together, these developments suggest a coordinated and hopefully imminent effort on the part of Indian regulators to launch a more formalized and transparent market authorization process for medical device manufacturers.

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