Registration of medical devices is a state procedure designed to ensure that only quality

medical devices

Registration of medical devices is a state procedure designed to ensure that only quality, effective and safe products are placed on the market. The Registration Certificate (RC) is a document confirming the compliance of medical devices with the established requirements and confirming the fact of their registration in Australia. Therefore, Australia is a necessary document for the circulation of a medical device on the market. In other words, registration of medical devices is a prerequisite for their import, use, sale and production in Australia. This is according to the Australian Medical Devices Industry Association (AMDI). Medical devices can be classified into categories:

Patient care – medical devices used to monitor patients.

Advocacy – medical devices used to communicate information or to advocate on behalf of patients. Cost effective – medical devices used in order to decrease costs.

Medical devices, just like other manufactured goods in Australia are subject to quality requirements, which means that they are required to conform to quality standards and regulatory requirements. Compliance with regulatory requirements depends on the type of product being registered.

Medical devices are required to meet minimum standards to ensure quality, safety and to demonstrate the adherence to the quality requirements. Compliance with these requirements can require a significant investment in the manufacturing process. Besides the costly process of registration and the investment required for quality control in the production process, these requirements include requirements for manufacturing and testing in order to demonstrate the minimum regulatory compliance required for medical devices. Furthermore, they require the testing of medical devices for compliance with the standards and regulations which vary according to the product category. To demonstrate the compliance of the medical devices, patients and clinicians must provide evidence of the efficacy of the product.

These compliance requirements are not present in other industries, even those which have very strict regulatory requirements, such as automotive and aircraft. On the contrary, these regulations are very strict, considering that medical devices are used in addition to clinical procedures or medically unnecessary processes. This is the case because medical devices are intended to assist patients. Besides evaluating and assessing the performance of medical devices, medical practitioners also have to comply with the requirements of technical