Why is it so important to review and update your regulatory strategy?
Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with Brexit and the introduction of the new MDD and further changes planned for the coming years, it is important that a regulatory strategy is reviewed and updated as new and updated requirements are identified. New requirements and/or updates could have a significant impact on existing or new products. Regulatory standards are used to assess the safety, efficacy and quality of medical devices throughout the product lifecycle. There’s a direct relationship between regulatory strategy and product development.
It is recommended on a periodic basis that the organisation is proactive in performing regular checks of regulator websites (i.e. TGA, MHRA), harmonized standards and other applicable product resources, to ensure that your organisation is compliant with the applicable guidelines, regulation and standards. Signing up to regulatory agencies newsletters can be a quick and effective way to stay notified of what’s changing in the world.
It is important to demonstrate that the review has been performed. The organisation should ensure that there is a periodic check of guidelines, this can be reported in regulatory summaries presented at management review meetings or the manufacturer should be able to provide documented evidence to demonstrate that they have considered updates for applicability and that the device complies with the selected standards. This documentation can include the standard itself on file and how it was applied to the product i.e. gap analysis or risk analysis.
The medical device market can change in terms of technology, risk and marketing, therefore it’s imperative for manufacturer to be up to date on regulatory requirements and new developments.
KD&A can help you ensure that your regulatory strategy is current by performing an assessment of your current regulatory strategy or support the development of a regulatory strategy for new products. A regulatory strategy is critical as it maps the requirements to achieve successful market entry. For further information, please contact us and visit our web site.
About K D & A
KD&A provides expert regulatory consulting service to medical device and IVD companies selling on Australian and international markets.
TGA Medical Device Class I Update – Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices
November 9, 2020
June 4, 2020