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Therapeutic Goods Administration



  • オーストラリア薬品・医薬品行政局(TGA)は、欧州CEマーキングに加え、その他の外国医療機器規制当局の認証や承認も市販申請に使用することを認める予定です。
  • TGAは、米国FDA、カナダ保健省、日本医薬品医療機器総合機構(PMDA)、そして医療機器単一審査プログラム(MDSAP)監査組織の登録や認定を申請に有効な証拠として認める計画です。
  • オーストラリアで市販申請をする事業者は、上記機関の承認や登録があれば、TGAの審査が迅速に行われる可能性があります。

Update on ANZTPA Medical Device Regulatory Harmonization in Australia and New Zealand

Medical device market regulators in Australia and New Zealand have implemented a series of projects involving adverse event notification, device recall information and quality system inspections as part of the countries' long-term effort to establish a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).

Joint Australia-New Zealand Medical Device Regulatory System Closer to Implementation

Health ministers of Australia and New Zealand report progress toward launching a joint regulatory body for oversight of medical devices in both countries. Once operational, the new system will replace both the Australian Medicines and Medical Devices Safety Authority.