The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulations, issued detailed and exhaustive research dedicated to the timeframes of procedures related to the medical device registration process describing the typical lifecycle of a medical device.
Medical Device Regulation Comparison: Various Approaches and National Specifics
The main goal of the research is to analyze the regulatory approach utilized by the foreign authorities and compare it to the way and manner the TGA operates. For this purpose, the authority and the consultants analyzed the appropriate processes in countries that are members of the International Medical Device Regulators Forum (IMDRF), an association of regulating authorities cooperating to improve the medical device regulatory framework. At the same time, it is also important to pay attention to certain country-specific aspects, such as:
- Requirements to the medical devices implemented on the national level,
- National risk-based classification of medical devices,
- The utilization of the risk-based approach, providing that each device should be treated due to the actual and potential risk associated with the use of the device.
It is also important to mention that the current regulatory approach utilized in Australia differs substantially from ones implemented in other countries included in the scope of the research. For instance:
- Pre-market approval and market authorization are separate steps, but in most countries they are performed in one single procedure (the device that passes successfully the conformity assessment is deemed approved to be marketed). This leads to the situation when foreign conformity assessment is widely used to apply for inclusion in the Australian Therapeutic Goods Register (ARTG).
- Australian conformity assessment for high-risk medical devices includes the assessment of both the device itself and the quality management system (QMS) employed by its manufacturer too, while most of the countries divide these procedures into the separate processes,
- Australia employs its specific approach to the calculation of time, providing that any term calculation should be temporarily suspended during the period of time the authority waits for the applicant to respond the inquiry, while the overall period is calculated from the date the application was submitted together with the appropriate payment to the date when the authority makes its decision regarding the matter. At the same time, other countries calculate terms using the concepts of “business days” and “calendar days”, and the overall period calculation starts from the date the authority responds to the applicant for the first time. Australia also does not use a differentiated approach to the timeframes depending on the complexity of the device subject to review or its class in accordance with the risk classification, while many countries provide extended timeframes for the cases related to high-risk devices since they require more time to be evaluated properly.
The document also states that after making the appropriate adjustments to acknowledge the different approaches utilized by the countries, the timeframes prescribed by the TGA for high-risk medical devices are compatible with ones used in other countries. Actually, the Australian approach is quite close to ones utilized the UK and the Netherlands, despite the fact that the conformity assessment in the other countries is performed by the independent non-governmental entities (notified bodies) that are not the part to the national system of regulating authorities while in Australia the national regulating authority, the TGA, also performs the compliance assessment of all medical device subject to review. At the same time, Australia’s TGA is the only authority that allows the use of foreign conformity assessment authorizations to supplement a marketing application. This approach allows significantly reducing the time necessary to pass all registration procedures and also the costs associated with placing the device on the domestic market.
Now, the TGA is going to take certain steps aimed at the improvement of the national medical device regulatory framework to implement some of the best practices introduced by the foreign national regulating authorities adapting them to the specifics of existing legislation.
Medical Device Regulation in Detail
The scope of the research covers Australia and 7 other countries representing different parts of the world, namely the UK, Netherlands, Brazil, Singapore, Japan, Canada and the US. The general comparison of the approaches utilized in these countries is based on such criteria as the classification of medical devices in general and the particular procedures applicable to low risk and higher risk medical devices. The list of particular findings includes the following:
- Classification of medical devices. All of the countries covered by the comparison implement risk-based classification while only some of them detach in-vitro diagnostic (IVD) medical devices as a separate category (all countries except Japan, Canada and the US).
- Low-risk medical devices. Australian TGA requires applicants to submit applications for entering the device on the ARTG. A similar approach is also used in Canada, where the national regulating authority also requires such applications for Class I medical devices but also does not review them. The UK and the Netherlands require the applicants to issue a declaration of conformity, and Brazil, Singapore, Japan and the US utilize the notifications-based approach (it is important to mention that in the US it is required to indicate a predicate – a similar medical device that is already present on the market). Thus, in most of the countries, prior approval is not required for low-risk medical devices that allow the applicants (the manufacturers or their authorized representatives, e.g. suppliers or importers) to place the devices on the market without any additional delays. In most countries the manufacturer should hold the appropriate license and in some of them, compliance with the Good Manufacturing Practices is also required.
- Higher risk medical devices. In all of the countries covered by the research, the assessment is required in some form. The type of assessment depends on the class of the device (moderate or high risk) and particular countries. In some of them, such assessment should be performed by the duly designated notified (certification) body that is an independent legal entity eligible to perform the assessment of certain types of medical devices (usually explicitly indicated in the scope of designation) while in other countries this function is performed by the national regulating authorities themselves. Other points taken into consideration when determining the scope of examinations needed include the complexity of the device, the necessity of the full assessment, presence of the similar devices on the market, approval of the device by other regulating authorities (including the approval in the country of origin), the information available regarding adverse events and other safety issues that took place in any other country, and the period for which the device has been marketed in other countries.
Summarizing the information provided above it is possible to state that in spite of certain differences in approaches to the regulation and various mechanisms used in specific features of national legislation systems, the general principles the medical device regulations are based on are the same in all countries since all regulatory frameworks are intended to establish an optimal balance between ensuring public safety and making medical devices available to the patients.
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