How to do Australian TGA certification for medical apparatus?
I. Understand the basic concept of TGA certification
Before going into the process, it is first necessary to clarify the responsibilities of TGA and the meaning of certification. TGA is mainly responsible for regulating medical apparatus, drugs, supplements and other therapeutic supplies in Australia to ensure that their safety, quality and performance meet the requirements of Australian regulations. Obtaining TGA certification means that the product has been recognized to meet the regulatory standards of Australia and can be legally sold in the market.
It should be noted that the scope of TGA's supervision covers a variety of medical apparatus, from surgical equipment, diagnostic supplies to implantable devices, etc. Different categories of products may have different certification processes and requirements. Enterprises need to make accurate judgments on the classification of their products first.
2. Preparations: Understanding Regulations and Classification
Before applying for TGA certification, it is first necessary to clarify the classification and regulatory requirements of the product. Medical apparatus in Australia is divided into three grades according to the risk level: low, medium and high, and each grade corresponds to different regulatory requirements.
1. How to judge which category a product belongs to?
can be classified according to the use, design and technical parameters of the product. Low-risk medical apparatus, such as some basic surgical tools, may belong to the lower risk category; while implantable equipment, complex diagnostic instruments may belong to the high risk category. Enterprises should judge in combination with the classification standards and guidelines issued by the Australian TGA.
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