The RAQA Deep Dive Sessions are 30 minute fast paced, highly focused Zoom broadcasted sessions for regulatory affairs and quality assurance professionals. The intention is to let viewers get valuable and practical tips and guidance on how to improve their operations.
Theme: Demystifying the regulatory landscape, building a solid foundation
Expert Speaker:: Martin King
Welcome to the Hoodin RAQA Deep Dive Sessions blog post! In this edition, we'll explore insights from our recent session with industry expert Martin King on navigating global regulatory challenges in medical devices and in vitro diagnostics (IVD).
Here, we'll summarize key takeaways and practical tips shared during the session. Whether you're seeking guidance on overcoming regulatory hurdles, staying updated with industry shifts, or anticipating future trends, this post has you covered. Additionally, we'll address audience questions, offering expert insights to boost your regulatory confidence.
So, sit back, relax, and let's unravel the world of regulatory affairs and quality assurance!
Some of the questions discussed were:
What are the three biggest challenges one might face when navigating the global regulatory landscape?
What are some effective strategies RA professionals can use to stay current on the latest developments?
Looking ahead, what emerging trends or regulatory changes do you see impacting the medical device and IVD industry in the next few years?
Further down in this blog post, you will also find the Questions that came from viewers and Martin King's answers plus assets and links.
Watch the Full Webinar
🎙️ Speaker: Martin King
📚 Theme: Demystifying the regulatory landscape, building a solid foundation
🗓️ When: April 4, 4pm CET / 11am EST
⏱️ Duration: 33 minutes
Q&A and Resources:
How should startups adjust their regulatory strategies and mindset to effectively navigate this global expansion?
Startups need to adopt a proactive approach to regulatory compliance, integrating it into their business strategy from the outset. It's important to allocate adequate resources for experienced regulatory expertise, prioritize markets based on product demand and regulatory requirements, and establish a scalable regulatory framework to accommodate expansion.
Is there an optimal sequence for regulatory alignment for European medical device startups aiming for global expansion?
Initiating compliance with the EU Medical Device Regulation (MDR), including UK Conformity Assessed (UKCA) marking and Mutual Recognition Agreements (MRA), followed by adherence to US FDA regulations, and subsequently leveraging the Medical Device Single Audit Program (MDSAP) for broader international reach, represents a strategic sequence for regulatory alignment.
Are there any countries that accept FDA or EU MDR/IVDR approvals, or do separate approvals need to be obtained for each country outside Europe?
While some countries may accept FDA or EU MDR/IVDR approvals through mutual recognition agreements or reliance mechanisms, many require separate approvals. However, initiatives like the MDSAP aim to streamline regulatory processes across multiple jurisdictions, facilitating international market access.
Several countries outside of the EU recognized CE Marking as part of their country specific regulatory submission but not always as a 1:1 Including but not limited to . UK, Türkiye Cumhuriyeti, Switzerland, EFTA countries, EEA Countries, Australia, New Zealand, Canada, Israel, Japan, India, North Macedonia, Serbia, Montenegro, Singapore, Saudi Arabia, UAE, Egypt, Morocco, South Africa, Argentina In some countries CE Marking is a good reference that can help expedite approval.
Do we have any suggestions for a template for regulatory strategy?
Crafting a comprehensive regulatory strategy requires a tailored approach based on product characteristics, target markets, and business goals. While there's no one-size-fits-all template, RA professionals can utilize resources provided by regulatory agencies, industry associations, and consultancy firms to develop a robust strategy encompassing compliance, risk management, and market access. It is strongly recommended to use MDCG templates when available for EU submissions.
Assets with Links from the Session: