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Is it necessary to have FDA certification to export to Australia?
Category：行业资讯 Date：2024-08-15 16:46:06 Author: Source:
​No, it is not necessary to have FDA certification to export medical devices to Australia. Australia has its own regulatory body, the Therapeutic Goods Administration (TGA), which oversees the approval and certification of medical devices. To export medical devices to Australia, you must obtain TGA registration, which ensures that your device meets Australian safety and performance standards. FDA certification is not a requirement for the Australian market, although having FDA approval might facilitate the process in some cases due to the perceived quality assurance it represents. However, you need to ensure compliance with TGA regulations to legally sell your products in Australia.

No, it is not necessary to have FDA certification to export medical devices to Australia. Australia has its own regulatory body, the Therapeutic Goods Administration (TGA), which oversees the approval and certification of medical devices. To export medical devices to Australia, you must obtain TGA registration, which ensures that your device meets Australian safety and performance standards. FDA certification is not a requirement for the Australian market, although having FDA approval might facilitate the process in some cases due to the perceived quality assurance it represents. However, you need to ensure compliance with TGA regulations to legally sell your products in Australia.7(2).jpg

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