Canada, with its population of over 38 million, relies heavily on imports to meet approximately 70% of its domestic demand for medical devices. The country's medical device sector is witnessing a surge in demand, fueled by an increase in chronic diseases and an aging population.
This presents a significant opportunity for global medical device manufacturers who are prepared to navigate CMDR Canada medical device registration and approval requirements.
Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO), established under the Drugs and Cosmetics Act of 1940. While the Act has undergone multiple amendments, the regulatory framework for medical devices remains relatively simple. India’s current system provides a specific list of medical device types that require registration, but lacks the sophistication found in other countries’ regulatory processes.
Recent Regulatory Updates
A significant regulatory shift took place on October 1, 2023. From this date, all medical devices—regardless of their notification status or risk classification—are required to have manufacturing, import, sales, and distribution licenses, and must be registered with either central or state regulators in India.
These changes were introduced through amendments to the Drugs and Cosmetics Act of 1940, the Drugs and Cosmetics Rules of 1945, and the Medical Device Rules of 2017. While this has expanded regulatory oversight, the process remains basic, with government notifications previously listing the specific devices requiring registration.
Canada, with its population of over 38 million, relies heavily on imports to meet approximately 70% of its domestic demand for medical devices. The country's medical device sector is witnessing a surge in demand, fueled by an increase in chronic diseases and an aging population.
This presents a significant opportunity for global medical device manufacturers who are prepared to navigate CMDR Canada medical device registration and approval requirements.
Regulatory Environment for Medical Devices
Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO), established under the Drugs and Cosmetics Act of 1940. While the Act has undergone multiple amendments, the regulatory framework for medical devices remains relatively simple. India’s current system provides a specific list of medical device types that require registration, but lacks the sophistication found in other countries’ regulatory processes.
Recent Regulatory Updates
A significant regulatory shift took place on October 1, 2023. From this date, all medical devices—regardless of their notification status or risk classification—are required to have manufacturing, import, sales, and distribution licenses, and must be registered with either central or state regulators in India.
These changes were introduced through amendments to the Drugs and Cosmetics Act of 1940, the Drugs and Cosmetics Rules of 1945, and the Medical Device Rules of 2017. While this has expanded regulatory oversight, the process remains basic, with government notifications previously listing the specific devices requiring registration.
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