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Medical device legislation refers to the laws and regulations that govern the design, development, testing, manufacturing, and marketing of medical devices. The primary purpose of medical device legislation is to ensure that medical devices are safe and effective for their intended use. Here are a few examples of medical device legislation and regulatory bodies that are in place in different countries:
United States: In the United States, medical devices are regulated by the Food and Drug Administration (FDA). The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for reviewing and approving medical devices before they can be marketed to the public. The FDA’s Medical Device Reporting (MDR) program is responsible for monitoring the safety of medical devices once they are on the market.
European Union: In the European Union (EU), medical devices are regulated by the European Medicines Agency (EMA). The EMA’s Medical Devices Coordination Group (MDCG) is responsible for reviewing and approving medical devices before they can be marketed within the EU. The EMA’s Vigilance and Post-Market Surveillance (VPMS) program is responsible for monitoring the safety of medical devices once they are on the market.
Canada: In Canada, medical devices are regulated by Health Canada. The Medical Devices Bureau (MDB) is responsible for reviewing and approving medical devices before they can be marketed to the public. Health Canada’s Medical Device Incident Reporting program is responsible for monitoring the safety of medical devices once they are on the market.
Japan: In Japan, medical devices are regulated by the Ministry of Health, Labour and Welfare (MHLW). The Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for reviewing and approving medical devices before they can be marketed to the public.
Australia: In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). The TGA is responsible for reviewing and approving medical devices before they can be marketed to the public and for monitoring the safety of medical devices once they are on the market.
This is not an exhaustive list, but highlights some examples of the key regulatory bodies for medical devices in different countries. Each country has its own set of laws and regulations that govern the approval and monitoring of medical devices, which are intended to provide a high level of protection for patients and healthcare professionals while ensuring that they have access to safe and effective medical devices.
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