Different countries have introduced regulations that mandate bicomapatibility and other functionalities fo medical devices.The regulatory authorities include Australian Therapeutic Goods Administration (TGA) (Australia), Health Canada (Canada), China Food and Drug Administration (China), The National Agency for the Safety of Medicines and Health Products (ANSM) (France), Federal Institute for Drugs and medical Devices (BfArM) (Germany), Medicines & Healthcare products Regulatory Agency (MHRA) (UK), US Center for Devices and Radiological Health (CDRH) (US), Food and Drugs Administration (FDA).
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