FPA Patent Attorneys’ Post

🕠 One patent every 30 minutes: this is the level of research and innovation brought by the medical technology sector in Europe    Medical technology is the second highest among all industrial sectors in Europe for the number of patent applications.    Read the new MedTech Europe’s Facts & Figures 2024 to discover the sector's impact in Europe 👉 https://bit.ly/3U8Q3AE 

This article explores the critical aspects of conducting medical device clinical trials in Mexico.

Pure Global is Heading to CMEF Shenzhen 2024! 🚀 From October 12th to 15th, the China International Medical Equipment Fair (CMEF and ICMD) will gather innovators and thought leaders across the medtech world—and guess what? Pure Global will be there! While we won’t have a booth this year, our Pure Global China team will be attending, ready to connect and discuss how we can support your regulatory and compliance journey. Whether it's navigating complex global markets, ensuring your products meet the highest safety standards, or accelerating time to market, we’re excited to share our expertise. Let’s make the most of this opportunity to engage and grow! If you're attending, drop us a message or look out for the Pure Global team on the ground. We’d love to connect. #CMEF2024 #PureGlobal #MedicalDevices #MedTech #RegulatoryAffairs #ChinaMedTech #Compliance #GlobalMarkets #Shenzhen

#2023relections The 1st UK-China Medical Devices Access to China Roundtable - Unleash your export potential Troy Chen highlighted two key factors for UK companies considering entering China from a venture capitalist perspective. #innovation #healtheconomics 🌟Enjoy and stay tuned for more video-clips on #MarketAccess #UKSMEEXPORT

In the growing market of electromedical devices, achieving global market access is crucial for sustainable growth — especially for startups and SMBs. A key component of accessing target markets worldwide is demonstrating compliance with varying standards, including key standards like IEC 60601/ ISO 80601 series, IEC 61010 series, and local regulatory requirements. However, the regulatory landscape governing medical devices and equipment is both intensive and complex. Often this leads to challenges that cause delays and frustrations for manufacturers that may result in increased costs. Learn how you can leverage a global network of certification experts to seize global market opportunities today: https://bit.ly/4cNaWe8

Are you struggling to navigate the intricacies and requirements of usability/human factors study in China and the US? Our guest speaker Di Lu, manager, digital health of regulatory affairs from MCRA, our principal Grace Fu Palma , regulatory and clinical project manager Yan Sheng will present: Usability/Human Factors Study: Understanding the Requirements in China and the U.S Time: Jun 27, 2024 11:00 AM in EST The role of usability and human factors in medical devices has become globally important across most of the key countries. In this session, we will focus on US and China to review the human factors extending beyond design and into registration and post-market phases. Join us for a comprehensive webinar that explores this crucial topic, focusing on the unique landscapes of China and the United States. • The Global Rising Importance: An introduction to why usability and human factors have become integral in medical device lifecycle. • Regulatory Insights: A comparative study of the regulatory guidelines in China and the U.S., highlighting the common and different requirements • Key Steps of Human Factor Studies & Design Strategies: how to design and implement the human factor studies • Real-world Examples & Best Practices 😊 Free Registration: https://lnkd.in/e_Rz6kQ8 #Chinamarket #USmarket #regulatoryaffairs #NMPA #ChinaFDA #medicaldevice #usabilitystudy #humanfactorstudy

The NMPA's Center for Medical Device Evaluation recently released a second draft of the "Guidance Principles for the Registration review of Human Factors Design in Medical Devices" for public review. PDD is a founding executive member of the Human Factors Special Committee and has been promoting HFE principles in China since 2015. From our studio in Shanghai, we partner with global healthcare clients to develop solutions that meet the needs of patients and HCPs in China and Asia. Our work ranges from wearable and handheld drug delivery devices to diagnostics, monitoring and large-scale imaging equipment. This article outlines how the latest draft will impact companies looking to enter or expand in China and how integrating HFE early in the development process, can future-proof their business in this competitive, rapidly evolving market. If you would like to learn more get in touch with Vicky Hong who would be happy to answer any questions you may have. You can read the full article here 👉 https://lnkd.in/gkBYxKQp #NMPA #humanfactors #medicaldevices #healthcareinnovation #drugdelivery #diagnostics #china

In the growing market of electromedical devices, achieving global market access is crucial for sustainable growth — especially for startups and SMBs. A key component of accessing target markets worldwide is demonstrating compliance with varying standards, including key standards like IEC 60601/ ISO 80601 series, IEC 61010 series, and local regulatory requirements. However, the regulatory landscape governing medical devices and equipment is both intensive and complex. Often this leads to challenges that cause delays and frustrations for manufacturers that may result in increased costs. Learn how you can leverage a global network of certification experts to seize global market opportunities today: https://bit.ly/4cNaWe8

Did you know? 😮   The global market for Software as a Medical Device (#SaMD) is growing rapidly and, according to various forecasts, will be worth 86.5 billion US dollars by 2027.   Japan has recognized the potential of SaMD and has taken steps to promote the development and commercialization of these innovative medical solutions. So the time is right for European #MedTech and #DigitalHealth companies to enter or expand into the Japanese market. 🇯🇵🤝🇪🇺   🤔 But how does market entry in Japan work? What current conditions need to be considered and what other trends besides SaMD are there in the Japanese life science sector?   😀 To share as much knowledge as possible with all interested parties, MAGIA2Market Alliance & KOBE Biomedical Innovation Cluster (#KBIC) invite you to a webinar on 𝗠𝗮𝗿𝗰𝗵 𝟮𝟳, 𝗳𝗿𝗼𝗺 𝟵:𝟬𝟬 𝘁𝗼 𝟭𝟬:𝟭𝟱. Sign up – it's free of charge ⏩ https://lnkd.in/dWQ_x8YR   And the lineup is worth seeing!   🎯 Sarah Niemann, #LifeScienceNord: Overview of the #MAGIA/#FBRI Collaboration   🎯 Takako Yokochi, FBRI: Exploring the Kobe Biomedical Innovation Cluster   🎯 Tadanori YASUDA, FBRI: Understanding SaMD in Japan: Market, Regulation, and Reimbursement   🎯 Keiko Kobayashi, FBRI: Innovation in Bio-Pharma and Regenerative Medicine   🎯 U. D. Haul, Dürr Dental Japan K.K.: Case Study – Dürr Dental's Success in Japan   🎯 Daniel Gralki, EU-Japan Centre for Industrial Cooperation: Fostering EU-Japan Business Collaborations   We are of course delighted that our MAGIA activities together with bioPmed - Piemonte Healthcare Cluster, BioWin - The Health Cluster of Wallonia, Lyonbiopôle Auvergne-Rhône-Alpes and our close friends in #Japan continue to bear fruit!

Is Regulatory Affairs more science than art? This is the topic of Regulatory Affairs Professionals Society (RAPS) Euro Convergence 2024 here in Berlin. Flora Giorgio of the European Commission explains well how this painting by Degas represents all the various stakeholders in the orchestra (regulatory bodies) are creating an environment to help manufacturers (the ballerinas) bring medical devices and drugs to patients (the audience). Both science and art then. What are your thoughts? Are you more artist or scientist? #RAPSEuroConvergence