Medical equipment is included in the List of goods subject to state registration in order to obtain a registration certificate from the Federal Service for Surveillance in Healthcare and Social Development in accordance with the administrative regulations on the execution of the state function of registering medical devices in Australia. A voluntary certificate may be issued for this type of product on the basis of a protocol confirming the compliance of the product with the Uniform Sanitary and Epidemiological Norms and Requirements.
Medical device compliance systems are published in the Healthcare Product Regulations (HPR) for certain medical devices for compliance with the requirements of the Food and Drugs Regulations, and include a system of pre-approval for medical devices.
Research and development of the medical device is subject to the Australian Government. Where a product is designed as a medicinal product or an investigational device, it must be registered with the Commonwealth Government’s Medicines and Healthcare Products Regulatory Agency, before it is marketed in Australia.
Issues relating to medical device compliance systems in developing countries
In developing countries, the Ministry of Health is responsible for the compliance of medical devices with their local regulations. The decision to approve medical devices must be in compliance with the current regulations in the country, and generally a mandatory safety assessment must be carried out in accordance with the national guidelines of the Ministry of Health. Failure to comply with regulations and the decisions of the Ministry of Health in the context of the pre-licensing, post-licensing or post-approval stages may result in the cancellation of the licensing application.
Other issues for medical device compliance systems in developing countries
Implementation of the requirements for medical device compliance systems must also comply with the countries legislation, regulations and existing practices, which often do not comply with international standards. As a result, medical device compliance systems are developed and implemented in a situation where international standards are not applicable. Compliance in developing countries therefore requires the involvement of medical devices compliance systems consultants in the development of these systems and their use for compliance purposes.
Specific devices and systems are excluded from the List of medical devices subject to state registration in Australia and may not be registered. The HPR specifically excludes registered medical devices with a 510(k) clearance (i.e. pre-market approval from the US FDA) under the US National Institute of Drug Abuse (NIDA), or a Food and Drug Administration (FDA) pre-market clearance.