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Important Notice! Australian TGA ends acceptance of ISO 13485 certificates as evidence of IVD product approval
2024-01-10

Recently, the Australian Medical Device Regulatory Authority (TGA) issued a statement announcing that the transition period for ISO 13485 certificates as evidence for manufacturers of in vitro diagnostic (IVD) medical devices has ended on May 26, 2023.
Key points of the classification of mechanical font sizes: the differences between mechanical Ⅰ, mechanical Ⅱ and mechanical Ⅲ
2024-01-10

The difference between medical device classification levels Medical devices have different classification levels in the domestic market to distinguish their risk levels and management requirements. These classification levels are called mechanical font sizes, including mechanical Ⅰ, mechanical Ⅱ and mechanical Ⅲ. Understanding the differences between these machine font sizes is critical for manufacturers, regulators and consumers alike. The following will introduce the differences between Mac
Understand these 6 questions about European representatives and choose your EU authorized representative correctly
2024-01-10

EU Authorized Representative An EU Authorized Representative is an institution or a natural person who represents a non-EU manufacturer within the EU. They are charged with ensuring that manufacturers comply with EU regulations and communicating and coordinating with EU regulators, customers and other stakeholders.

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