Medical Device Global Market Access

This episode delves into the UK's Medicines and Healthcare products Regulatory Agency (MHRA) guidance, updated 20 May 2025, on utilizing Real-World Data (RWD) in randomised controlled trials for regulatory decisions. We explore the scope, design considerations, safety monitoring, and regulatory acceptability of RWD-based trials, highlighting their potential to streamline drug development, particularly for label expansions and repurposing existing medicines. Key Questions: • What is the MHRA's latest stance on using Real-World Data in clinical trials as of May 2025? • How can RWD potentially reduce burdens and accelerate regulatory submissions for medicinal products? • What are the critical design elements for a successful RWD-based randomised controlled trial? • When might blinding be necessary in RWD studies, and why? • How does the MHRA view the evidentiary value of RWD trials compared to traditional RCTs? • What are "Type A" clinical trials, and how does this classification impact safety reporting requirements? • What are some of the most suitable scenarios for leveraging RWD in clinical investigations, such as drug repurposing? • Are there specific considerations for designing non-inferiority trials that use RWD sources? • How is the guidance expected to evolve concerning medical devices and RWD? • Where can sponsors obtain further advice from the MHRA on their specific RWD trial proposals? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30 + markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode unpacks the UK MHRA's updated May 20, 2025, guidance on employing Real-World Data (RWD) in clinical studies for regulatory approval. We discuss the scope, the critical emphasis on data quality, essential considerations for sponsors using RWD sources like EHRs and wearables, and how the MHRA is shaping the future of evidence generation for medical products. Key Questions: • What exactly is Real-World Data and how is it changing regulatory submissions? • According to the MHRA's 2025 update, what defines high-quality RWD for clinical studies? • What are the major advantages and potential pitfalls of integrating RWD into your development strategy? • Which specific data quality aspects must sponsors meticulously address in their RWD study protocols? • How are emerging digital health technologies influencing RWD collection and its regulatory acceptance? • What scrutiny can be expected from MHRA during inspections of clinical trials utilizing RWD? • When is it advisable to proactively seek scientific advice from the MHRA on your RWD plans? • How can leveraging RWD ultimately streamline the path to market for new medical innovations? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of Brazil’s ANVISA process—and 30 + other markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode offers medical device manufacturers an essential overview of navigating global wireless compliance when integrating radio frequency (RF) modules. We explore crucial considerations from selecting RF module suppliers and understanding international certification pathways—like modular versus system-level approvals—to compiling necessary documentation and addressing specific restrictions for medical applications. Learn how early planning and a clear understanding of each target market's regulations can streamline your path to launching wireless medical devices worldwide. Key Questions: • What are the first steps when planning international wireless compliance for your medical device? • How can you effectively vet RF module suppliers for global markets? • Modular vs. System-level approval: Which path is right for your wireless device and what are the hidden complexities? • What critical documentation will you need from your RF module supplier for international submissions? • Are there unique regulatory challenges when using wireless modules in medical applications, like data transmission or SAR? • How do you ensure your wireless medical device meets varying country-specific technical standards? • What strategies can help avoid costly delays in getting your wireless medical device to global markets? • Who typically owns the RF module certification, and does it need to be transferred? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of wireless compliance and global market access for medical devices—in over 30 markets worldwide, including complex regions for RF certification. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode delves into the latest medical device registration data from Brazil, focusing on trends observed in March and April 2025. We explore the prevalence of Class I and II devices, particularly in diagnostics, the types of higher-risk Class IV devices gaining approval, and the manufacturing landscape, highlighting both strong domestic production and key international players from countries like China, Germany, and the USA. The host discusses specific device categories and the implications for manufacturers looking to enter or expand in the Brazilian market.Key Questions:• What types of medical devices are most frequently registered in Brazil according to recent 2025 data?• Which risk classes dominate the Brazilian medical device landscape?• Are Class IV devices being approved, and what are some examples from early 2025?• How significant is domestic manufacturing versus international sourcing in Brazil's MedTech sector?• Which countries were key exporters of medical devices to Brazil in early 2025?• What does the recent data reveal about the demand for diagnostic products in Brazil?• What are the key takeaways for MedTech companies considering the Brazilian market based on Q1 2025 insights?• When were these highlighted device registrations primarily published or updated?Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of Brazil’s ANVISA process—and 30+ other markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.