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Description
Navigate every market. Accelerate every launch.
Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut.
Why listen?
• Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other regimes, showing exactly how long each milestone really takes and where companies get stuck.
• First-hand war stories – Hear candid interviews with regulatory veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale.
• Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve.
• Actionable templates – From clinical evaluation checklists to technical-file skeletons, we break down the documents you’ll need and the pitfalls reviewers love to flag.
• AI-powered insights – Because Pure Global mines millions of public filings, tenders, and recalls, we surface data-backed best practices you won’t hear at conferences—or from competitors.
What you’ll hear
• Launching SaMD under multiple risk classes in parallel
• Surviving an unannounced ISO 13485 audit
• Building a “reg-first” QMS that scales
• Mastering Latin-American registrations without endless language cycles
• Leveraging real-world evidence to shorten clinical timelines
• Aligning cybersecurity, privacy, and post-market surveillance rules across regions
Whether you’re plotting first entry, managing lifecycle expansions, or rescuing a delayed submission, subscribing could shave months—and millions—off your path to revenue.
⸻
Brought to you by Pure Global – the AI-native consultancy that already guides MedTech innovators through regulatory and market-access hurdles in 30 + countries. Ready for expert help on your next submission? Visit https://pureglobal.com or email info@pureglobal.com to start accelerating today.
Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut.
Why listen?
• Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other regimes, showing exactly how long each milestone really takes and where companies get stuck.
• First-hand war stories – Hear candid interviews with regulatory veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale.
• Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve.
• Actionable templates – From clinical evaluation checklists to technical-file skeletons, we break down the documents you’ll need and the pitfalls reviewers love to flag.
• AI-powered insights – Because Pure Global mines millions of public filings, tenders, and recalls, we surface data-backed best practices you won’t hear at conferences—or from competitors.
What you’ll hear
• Launching SaMD under multiple risk classes in parallel
• Surviving an unannounced ISO 13485 audit
• Building a “reg-first” QMS that scales
• Mastering Latin-American registrations without endless language cycles
• Leveraging real-world evidence to shorten clinical timelines
• Aligning cybersecurity, privacy, and post-market surveillance rules across regions
Whether you’re plotting first entry, managing lifecycle expansions, or rescuing a delayed submission, subscribing could shave months—and millions—off your path to revenue.
⸻
Brought to you by Pure Global – the AI-native consultancy that already guides MedTech innovators through regulatory and market-access hurdles in 30 + countries. Ready for expert help on your next submission? Visit https://pureglobal.com or email info@pureglobal.com to start accelerating today.
214 Episodes
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This episode explores the transformation of the U.S. hearing aid market following the FDA's landmark 2022 rule that established an over-the-counter (OTC) category. We analyze the impact on accessibility, device innovation, and affordability, while also examining the continued importance of the prescription hearing aid channel. The discussion covers early market analyses from 2024 and the outlook for 2025, highlighting the factors that make hearing aids a key medical device category.
- What was the FDA's landmark hearing aid rule in 2022?
- How did the creation of an OTC category change market access for consumers?
- Why did so few people who needed hearing aids use them historically?
- What technological innovations are emerging in OTC hearing aids?
- What is the ongoing role of prescription hearing aids fitted by audiologists?
- What do early 2024 and 2025 analyses reveal about the new market?
- Why are hearing aids one of the most popular device categories for 2025?
- How can manufacturers navigate this dual OTC and prescription market?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and advanced AI. We act as your local representative in over 30 markets, developing efficient regulatory strategies and using AI to compile technical dossiers. From initial market research to post-market surveillance, our integrated approach helps you expand efficiently. Whether you're a startup or a multinational enterprise, Pure Global provides the solutions to get your innovations to patients faster. To learn more, visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
This episode explores the robust and growing U.S. market for Continuous Positive Airway Pressure (CPAP) and Automatic Positive Airway Pressure (APAP) devices used to treat obstructive sleep apnea (OSA). We delve into the key factors driving sustained, double-digit demand, including the high prevalence of OSA among American adults. The discussion also covers the maturation of the clinical and payer ecosystem, which now better supports long-term patient adherence through innovations like home sleep testing, tele-monitoring, and diverse mask options, ensuring the continued dominance of this essential home-use medical device.
Key Questions:
- Why is CPAP therapy considered the first-line treatment for obstructive sleep apnea?
- How large is the estimated patient population for OSA in the United States?
- What market trends are driving the sustained, double-digit demand for these devices?
- How has the healthcare ecosystem evolved to overcome challenges with patient adherence?
- What role are consumer wearables playing in the future of sleep apnea diagnosis?
- Are there emerging alternative therapies to CPAP/APAP devices?
- What makes the CPAP market a unique example of a popular home-use medical device?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and advanced AI. Our services cover the entire product lifecycle, from initial regulatory strategy and technical dossier submission to post-market surveillance. By leveraging our global network and technology-driven efficiency, we help companies navigate complex regulatory landscapes and accelerate their entry into over 30 markets worldwide. To learn how we can help you access global markets faster, visit us at https://pureglobal.com/, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
This episode explores the dynamic landscape of Cardiac Implantable Electronic Devices (CIEDs), including pacemakers, ICDs, and CRT devices. We discuss why these devices are now a routine therapy, driven by an aging population and technological advancements. We cover key innovations like leadless technology, remote monitoring, and MRI-conditional labeling, and examine market trends for 2024-2025, including conduction-system pacing, highlighting how these devices remain a cornerstone of modern cardiology.
Key Questions:
- What factors are driving the widespread adoption of CIEDs?
- How many new CIEDs are implanted annually in the U.S. alone?
- What are the most significant recent innovations in pacemaker and ICD technology?
- How does cloud-based remote monitoring improve patient outcomes and clinic efficiency?
- What does the large existing patient base mean for the future of the CIED market?
- What key trends for 2024–2025 are shaping the next generation of cardiac implants?
- Why are these devices considered a mainstay for treating arrhythmias and heart failure?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate the complex global market for devices like CIEDs. We develop efficient regulatory strategies and use advanced AI to compile technical dossiers for submission, streamlining your path to market access. Whether you're a startup or a multinational enterprise, our local experts across 30+ markets can act as your representative and ensure continuous compliance. To accelerate your global expansion and access free AI tools and regulatory databases, visit us at https://pureglobal.ai or contact info@pureglobal.com.
This episode delves into the U.S. market for hip and knee replacement implants, analyzing data from the American Joint Replacement Registry’s 2024 report. We explore the procedural volumes, key market trends for 2025 such as the shift to outpatient settings, the rise of robotics, and the growing demographic of younger patients seeking joint arthroplasty to maintain active lifestyles.
- What does the American Joint Replacement Registry's 2024 report reveal about the U.S. market?
- Why do knee replacements constitute nearly half of all major joint arthroplasty cases?
- How is the industry-wide shift to outpatient settings impacting implant manufacturers?
- What role are robotics and cementless fixation playing in modern orthopedic surgery?
- Why are younger patients increasingly seeking hip and knee implants?
- What are the dominant market dynamics for orthopedic devices in the U.S. for 2025?
- How can medical device companies adapt their regulatory strategy to these evolving trends?
Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies seeking to accelerate global market access. We combine in-country expertise across more than 30 markets with advanced AI and data tools to streamline your journey. From developing regulatory strategy and compiling technical dossiers to acting as your local representative and ensuring post-market compliance, we offer end-to-end solutions. Our unique 'single process, multiple markets' approach maximizes efficiency, helping startups and multinational enterprises alike. To learn how we can help you navigate the global landscape, visit us at https://pureglobal.com/, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
This episode explores the rapid adoption of Continuous Glucose Monitors (CGMs) and insulin pumps in the United States, detailing how changes in reimbursement policy, specifically from the Centers for Medicare & Medicaid Services (CMS) in April 2023, transformed these devices from niche products to mainstream standards of care for a growing number of people with both type 1 and type 2 diabetes.
- How did CGM technology transition from a niche to a mainstream medical device in the U.S.?
- What critical role did CMS play in expanding market access for CGMs?
- Why are more people with type 2 diabetes now using CGMs than those with type 1?
- What specific policy change in April 2023 opened the door for millions more patients?
- How have both public and commercial insurance plans fueled the CGM boom?
- What technological advancements are driving competition among manufacturers in 2025?
- How are policy, technology, and data combining to reshape modern diabetes care?
Navigating complex regulatory environments like the U.S. requires deep expertise. Pure Global offers end-to-end consulting for MedTech and IVD companies, leveraging local experts and advanced AI to streamline global market access. We develop efficient regulatory strategies, manage technical dossier submissions, and act as your local representative to ensure your product gets to market quickly and stays compliant. Whether you are a startup or a multinational, our solutions are tailored to your needs. Contact us at info@pureglobal.com, visit our website at https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.
This episode explores how MedTech companies are leveraging advanced AI agents to overcome traditional hurdles in global medical device regulation. We discuss the shift from slow, manual processes to an automated, intelligent strategy that monitors real-time regulatory changes, streamlines technical dossier preparation for over 30 markets, and accelerates time-to-market by up to 75%, transforming the landscape for startups and multinational enterprises alike.
- How can AI agents monitor real-time regulatory changes across 30+ countries?
- What are the biggest challenges in traditional global medical device registration?
- Can AI really reduce the time-to-market for a new medical device by 75%?
- How does an AI-powered approach minimize submission rejections from authorities like the FDA or Notified Bodies?
- What specific tasks in dossier preparation can be automated with AI?
- How can you leverage your existing technical documentation for faster entry into new markets?
- What does the future of MedTech regulatory affairs look like with the rise of AI?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, leveraging AI to streamline global market access. Our experts, combined with powerful data tools, help you navigate complex landscapes across 30+ markets, from the US and EU to Asia. We develop efficient regulatory strategies, use AI to compile technical dossiers, and act as your local representative to get your products to market faster. If you're looking to accelerate your global expansion, visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
This episode explores real-world case studies of MedTech companies using advanced AI agents to accelerate FDA submissions, expand into multiple European markets simultaneously, and maintain compliance in complex regions like Japan. We break down how AI is reducing preparation times by 70%, driving revenue growth by 300%, and preventing costly regulatory missteps for Class II, Class III, and diagnostic devices.
- How can AI reduce FDA submission preparation time by over 70%?
- What tools help companies identify and enter 8 new European markets at once?
- How did one company achieve a 300% revenue increase in 18 months through regulatory strategy?
- What is the most effective way to monitor real-time regulation changes in key markets like Japan?
- How can AI agents improve the accuracy and compliance confidence of your regulatory team?
- What proactive measures can prevent costly recalls from missed regulatory updates?
- What are the tangible benefits of AI for companies with Class II and Class III medical devices?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, leveraging AI and local expertise to accelerate global market access. Our AI-powered tools streamline technical dossier preparation, our market access agents identify the most efficient registration pathways, and our compliance monitors provide real-time updates to protect your market presence. We act as your local representative in over 30 markets, turning a complex global strategy into a streamlined process. To learn how we can help your company expand, visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
This episode details the full range of medical devices and regulatory services supported for global market access. We explain our expertise with both MedTech and In-Vitro Diagnostic (IVD) products, from simple tools to complex software. The discussion covers the complete lifecycle of our services, including initial regulatory strategy, AI-powered technical submissions, local representation in over 30 markets, post-market surveillance, and continuous compliance monitoring tailored for startups, scaleups, and large multinational enterprises.
- What specific types of MedTech and IVD devices do you support?
- How can a 'Single Process, Multiple Markets' approach accelerate global expansion?
- What is the role of AI in streamlining technical dossier submissions?
- Which services are critical for maintaining market compliance after a product is launched?
- How is regulatory support tailored for startups versus multinational corporations?
- What does an end-to-end regulatory solution include?
- Why is a local, in-country representative essential for market access?
- How can you stay ahead of constantly changing international regulations?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with a unique blend of local expertise and advanced AI. Our services cover the entire product lifecycle, from regulatory strategy and technical dossier submissions to post-market surveillance and quality assurance. By acting as your local representative in over 30 markets, we enable a 'Single Process, Multiple Markets' approach, accelerating your expansion. Discover how our technology-driven solutions can help your company grow. Visit https://pureglobal.com, contact us at info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
This episode explores how regulatory strategies for MedTech and IVD devices must adapt to a company's growth stage. We discuss the unique challenges and tailored solutions for startups seeking initial market entry, scaleups planning international expansion, and multinational enterprises managing complex global portfolios. Learn how a strategic approach, from agile guidance to AI-powered compliance, can support your company at every step of its journey.
- How do the regulatory challenges of a startup differ from those of a multinational enterprise?
- What should a fast-growing scaleup look for in a global regulatory partner?
- Can a single registration process be leveraged to enter multiple international markets?
- How can AI and data tools streamline technical dossier submission and market research?
- What are the key strategies for maintaining compliance across a diverse global product portfolio?
- Are there cost-effective ways for startups to navigate complex regulations in the EU, US, or Asia?
- How can a company choose the right international markets for strategic expansion?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies at every stage of growth. Whether you're a startup needing agile guidance, a scaleup expanding globally, or a multinational enterprise optimizing a complex portfolio, our solutions are designed for your specific needs. We leverage our local expertise in over 30 markets and advanced AI data tools to accelerate your growth, from initial strategy and technical dossier submission to post-market surveillance. Contact Pure Global at info@pureglobal.com, visit us at https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
This episode explores the evolution of regulatory consulting for MedTech and IVD devices. We contrast the traditional, fragmented consulting model with Pure Global's integrated, technology-driven approach. Discover how AI, a unified global-local team, and an end-to-end service model are revolutionizing how companies achieve faster, more efficient market access in over 30 countries.
- Why does the traditional multi-consultant model often lead to higher costs and delays?
- How can a "single process, multiple markets" strategy accelerate your global expansion?
- What role does Artificial Intelligence play in compiling technical dossiers and submissions?
- How does having dedicated local offices differ from a network of third-party agents?
- Can you leverage one partner for everything from initial strategy to post-market surveillance?
- What advantages does a database of over 5 million products offer for clinical data analysis?
- How is a technology-driven approach changing regulatory affairs from a cost center to a strategic advantage?
Pure Global offers end-to-end regulatory solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. Our integrated approach enables a single registration process for multiple markets, from the US and EU to Asia. We support startups and multinationals with regulatory strategy, technical submissions, and post-market surveillance. For faster, technology-driven market access, visit https://pureglobal.com or contact info@pureglobal.com. Explore our free AI tools and regulatory database at https://pureglobal.ai.
This episode explores how MedTech and IVD companies can overcome the complexities of international expansion. We discuss a unified, technology-driven approach to registering medical devices in over 30 global markets simultaneously, covering everything from initial regulatory strategy and market selection to the role of local representation and AI-powered technical dossier submissions.
Key Questions:
- How can you enter 30+ global MedTech markets with a single registration process?
- What are the critical first steps in developing a global regulatory strategy?
- Why is local representation essential for market access in countries like Brazil or South Korea?
- How can AI accelerate the creation and submission of your technical dossiers?
- What's the key to selecting the most promising international markets for your device?
- How do you maintain compliance after your product is approved abroad?
- Can one unified approach work for both startups and multinational corporations?
Pure Global provides end-to-end regulatory consulting solutions for MedTech and IVD companies, streamlining access to over 30 global markets. We combine local expertise with advanced AI to manage the entire product lifecycle, from regulatory strategy and market selection to technical dossier submission and post-market surveillance. Our unique 'Single Process, Multiple Markets' approach simplifies expansion, saving you time and resources. Whether you're a startup or a multinational, we act as your local representative to ensure a smooth path to commercialization. For expert guidance, visit https://pureglobal.com/, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
This episode breaks down the crucial differences between free and paid resources in the complex world of medical device market access. We explore what you can achieve with publicly available information from regulatory bodies and when it becomes essential to invest in expert services for strategy, submission, and reimbursement to ensure a successful product launch. - What essential regulatory information is available for free?
- Are government websites and databases sufficient for building a full market entry strategy?
- When does it become critical to invest in paid consulting and local representation?
- How can you determine the return on investment for paid market access services?
- What are the hidden costs and risks of relying solely on free resources?
- Why is navigating reimbursement and Health Technology Assessment (HTA) bodies impossible without expert support?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We combine local expertise in over 30 markets with advanced AI tools to streamline global market access, from initial strategy and technical dossier submission to post-market surveillance. Our integrated approach allows a single registration process to unlock multiple markets, saving you time and resources. Whether you are a startup or a multinational enterprise, our solutions are tailored to get your innovations to patients faster. Contact us at info@pureglobal.com, visit our website at https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.
This episode explores the critical distinction between standalone AI SaaS tools and a fully integrated, service-based approach for MedTech global market access. We dissect why expensive software alone often falls short and how combining advanced AI with on-the-ground human expertise, local representation, and end-to-end regulatory services provides a more efficient and effective path to launching and maintaining products in over 30 international markets.
Key Questions:
- Is your expensive AI SaaS tool actually accelerating your global market access?
- What is the critical gap most standalone software solutions leave for your regulatory team?
- How can a single registration process unlock access to over 30 countries?
- What does an integrated service model offer that a pure SaaS platform cannot?
- Why is local, human expertise still irreplaceable in the age of AI?
- How can AI be used to empower a global team rather than just automate a single task?
- What should you look for in a true global regulatory partner?
Pure Global offers the end-to-end solution discussed in this episode. We don't just sell software; we provide a complete partnership for MedTech and IVD companies. Our approach combines advanced AI for efficiency with the critical expertise of local representatives in over 30 markets. From initial regulatory strategy and technical dossier submission to post-market surveillance, we streamline your entire global market access journey. Let us handle the complexities so you can focus on innovation. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai to see the difference.
This episode explores the strategies and regulatory hurdles involved in bringing medical devices to underserved and emerging global markets. We discuss how to leverage existing approvals, the critical role of local representation, and the use of technology to streamline multi-country submissions, focusing on promising regions like Latin America and Southeast Asia.
Key Questions:
- How can you leverage your existing US or EU approvals to enter new regions?
- What are the primary regulatory hurdles in Latin American and Southeast Asian markets?
- Why is local representation critical for success in underserved economies?
- How can technology streamline submissions for multiple, non-harmonized markets?
- What is the first step in identifying the most promising underserved markets for your device?
- Is it possible to use a single registration process to access dozens of countries?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with a unique blend of local expertise and advanced AI. We help you develop efficient regulatory strategies, act as your local representative in over 30 markets, and use AI to compile technical dossiers for faster submissions. Our integrated approach allows a single registration process to unlock multiple international markets simultaneously. To accelerate your global expansion and access our FREE AI tools and regulatory database, visit us at https://pureglobal.ai or contact our team at info@pureglobal.com.
This episode explores how Artificial Intelligence is revolutionizing the medical device registration process, breaking down financial barriers and enabling broader global market access. We discuss the shift from costly, manual submissions to an efficient, technology-driven model that allows MedTech companies of all sizes to bring life-saving innovations to patients worldwide. Learn how AI is not just a tool for efficiency but a force for democratizing global healthcare access.
Key Questions:
- How can AI drastically reduce the cost of medical device registration?
- What are the traditional barriers preventing MedTech companies from entering global markets?
- How does lowering registration costs impact patient access to life-saving devices?
- Can AI help you bring 10 times more products to 10 times more countries?
- Which global markets can be navigated using AI-powered regulatory intelligence?
- What specific tasks in the regulatory submission process can be automated?
- How is technology making global compliance accessible for startups and smaller companies?
Pure Global offers end-to-end regulatory solutions for MedTech and IVD companies, leveraging AI and local expertise to accelerate global market access. We help you develop regulatory strategies, compile technical dossiers with advanced AI, and act as your local representative in over 30 markets. Our goal is to make global expansion efficient and affordable, from initial strategy to post-market surveillance. Visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai to start your journey.
This episode explores the transformative impact of free AI-powered tools on the medical device industry. We discuss how making regulatory intelligence and global device databases accessible at no cost is breaking down financial barriers, enabling MedTech companies to expand their reach into new international markets more efficiently and affordably. This shift promises to accelerate the availability of life-saving technologies to patients around the world.
- How is Artificial Intelligence revolutionizing the MedTech regulatory landscape?
- What if you could access global medical device registration databases for free?
- Can AI genuinely lower the cost of market entry for life-saving devices?
- What specific AI-powered tools are now available to streamline compliance in over 30 markets?
- How can your company leverage free AI for device classification and regulatory pathway analysis?
- What is the vision behind making core regulatory AI agents completely free?
- How does this shift impact market access in regions like South America, Asia, and Africa?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, leveraging advanced AI to streamline global market access. We help you identify the best markets, develop efficient regulatory strategies, and use AI to compile and submit technical dossiers. Our integrated approach allows a single registration process to unlock multiple international markets, supported by local experts in over 30 countries. Whether you're a startup or a multinational enterprise, our technology-driven solutions accelerate your time-to-market. Explore our free AI tools and databases at https://pureglobal.ai, visit our website at https://pureglobal.com, or contact us at info@pureglobal.com.
This episode provides a detailed overview of Colombia's foundational medical device regulation, Decree 4725 of 2005. We explore the critical role of INVIMA, the risk-based classification system, key submission requirements for market approval, and post-market surveillance obligations for MedTech and IVD manufacturers looking to enter the Colombian market.
Key Questions
- What is Decree 4725 and why is it essential for market access in Colombia?
- How does INVIMA classify medical devices based on risk?
- What are the core components of a technical dossier for submission in Colombia?
- Is a local legal representative required to register a medical device in Colombia?
- What are a manufacturer's post-market surveillance responsibilities under Colombian law?
- How does Colombia's regulatory framework compare to others globally?
- What are the first steps to begin the medical device registration process in Colombia?
Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies targeting Latin America. We act as your local representative in Colombia, developing efficient regulatory strategies to navigate INVIMA's requirements under Decree 4725. Our experts and advanced AI tools streamline the compilation and submission of your technical dossier, helping you access the Colombian market faster. Whether you are a startup or a multinational, we ensure your market entry and post-market activities are fully compliant. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
This episode provides a detailed overview of Mexico's Technovigilance requirements for medical devices under COFEPRIS regulation NOM-240-SSA1-2012. We explore the mandatory post-market surveillance system, including the roles of the Sanitary Registration Holder, adverse event reporting timelines, and the documentation required for registration renewal. We also discuss the significant updates proposed in the draft 2024 version of the standard, which will impact software devices and distributor obligations.
- What is Technovigilance and why is it mandatory for medical devices in Mexico?
- Who is responsible for reporting adverse events to COFEPRIS?
- What are the specific reporting deadlines for serious and non-serious incidents?
- How does post-market surveillance impact the 5-year renewal of your sanitary registration?
- What is the function of a Mexico Registration Holder (MRH) in the Technovigilance process?
- What key changes are introduced in the draft PROY-NOM-240-SSA1-2024?
- Will Software as a Medical Device (SaMD) be covered under the new Technovigilance rules?
- What are the core components of a compliant Technovigilance unit?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, including Mexico, managing your registration and Technovigilance obligations. Our experts develop efficient regulatory strategies and use advanced AI to compile technical dossiers, ensuring compliance with bodies like COFEPRIS. Let us help you maintain your market presence with continuous regulatory monitoring and post-market surveillance support. For a seamless path to market, contact us at info@pureglobal.com, visit our website at https://pureglobal.com, or explore our free AI tools at https://pureglobal.ai.
This episode provides a critical update on Mexico's new mandatory standard for medical device labeling, NOM-137-SSA1-2024. The host breaks down the key changes from the previous 2008 version, including the strict Spanish language requirement, new provisions for electronic labeling and Software as a Medical Device (SaMD), and updated rules for symbols and date formats. We cover the official publication and effective dates, helping manufacturers understand the timeline for compliance to maintain market access in Mexico.
- What is the new mandatory labeling standard for medical devices in Mexico?
- When does NOM-137-SSA1-2024 officially come into effect?
- Are English labels still acceptable in Mexico under the new regulation?
- How does the new standard address electronic labeling and Software as a Medical Device (SaMD)?
- What are the specific requirements for displaying expiration dates and using symbols?
- What happens if my device labeling is not compliant by the deadline?
- How does this 2024 update differ from the previous NOM-137-SSA1-2008?
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We streamline global market access using a blend of local expertise and advanced AI. Whether you're navigating Mexico's new NOM-137 standard or expanding into any of our 30+ markets, our team can help with regulatory strategy, technical dossier submission, and post-market surveillance. Our technology-driven approach ensures efficiency and accuracy, helping you get to market faster. Explore our services at https://pureglobal.com, contact us at info@pureglobal.com, or access our FREE AI tools and database at https://pureglobal.ai.
This episode provides a detailed overview of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. The host breaks down the key requirements for medical device manufacturers, including the implementation of a Quality Management System, risk management protocols, and alignment with ISO 13485. We discuss the standard's scope, its effective date, and the practical implications for companies seeking to enter or remain compliant in the Mexican market.
Key Questions
- What is NOM-241-SSA1-2021 and why is it critical for the Mexican market?
- How does this standard impact the entire lifecycle of a medical device?
- What are the core requirements of a compliant Quality Management System under NOM-241?
- How does NOM-241 align with the international ISO 13485 standard?
- Are you prepared for a GMP inspection by Mexican authorities?
- What documentation is essential for demonstrating compliance?
- When did this mandatory standard become fully effective?
- Does this regulation affect foreign manufacturers importing into Mexico?
Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. We help you develop efficient regulatory strategies, compile technical dossiers, and act as your local representative in over 30 markets, including Mexico. Our technology-driven approach ensures you navigate complex standards like NOM-241 with confidence. For assistance with your market access needs, visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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