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Australia’s Therapeutic Goods Administration (TGA) is proposing to review products currently classified as Class I medical devices to see if they should be reclassified as consumer goods. Read More
The UK’s Medicines and Health products Regulatory Agency (MHRA) has issued new guidance on how to register a device manufacturer or authorized representative with the agency in order to sell devices and IVDs. Read More
The FDA is delaying UDI rule requirements for soft contact lenses until one year after it resolves a technical problem — and the agency has granted a third extension for labelers of the lenses. Read More