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  • Free AI Agents: The Future of Medical Device Registration in the US, EU, and Beyond

    Free AI Agents: The Future of Medical Device Registration in the US, EU, and Beyond
    2025/11/23
    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.
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    3 分
  • Colombia Medical Device Registration: Unpacking Decree 4725 of 2005

    Colombia Medical Device Registration: Unpacking Decree 4725 of 2005
    2025/11/22
    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.
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    3 分
  • Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success

    Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success
    2025/11/21
    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.
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    3 分
  • Mexico's New Medical Device Labeling Standard: A Deep Dive into NOM-137-SSA1-2024

    Mexico's New Medical Device Labeling Standard: A Deep Dive into NOM-137-SSA1-2024
    2025/11/20
    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.
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    3 分
  • Navigating NOM-241-SSA1-2021: Medical Device GMP Compliance in Mexico

    Navigating NOM-241-SSA1-2021: Medical Device GMP Compliance in Mexico
    2025/11/19
    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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    3 分
  • Navigating COFEPRIS: A Deep Dive into Mexico's 'Reglamento de Insumos para la Salud' for Medical Devices

    Navigating COFEPRIS: A Deep Dive into Mexico's 'Reglamento de Insumos para la Salud' for Medical Devices
    2025/11/18
    This episode provides a detailed overview of Mexico's medical device regulations, focusing on the Reglamento de Insumos para la Salud. We explore the role of the regulatory authority, COFEPRIS, the risk-based device classification system, and the available registration pathways, including the Standard and Equivalency routes. The host also covers the crucial updates from the 5th edition of the Mexican Pharmacopoeia's supplement, which became effective in July 2023. - What is the primary regulation for medical devices in Mexico? - How does COFEPRIS classify medical devices based on risk? - What is the difference between the Standard and Equivalency registration routes? - Which foreign approvals can be used to expedite registration in Mexico? - What key changes were introduced in the July 2023 regulatory update? - What are the documentation and language requirements for a submission? - Why is a Mexico Registration Holder (MRH) necessary for foreign manufacturers? - What is the role of the NOM-241 standard in Mexico's QMS requirements? 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 act as your local representative in over 30 markets, including Mexico, developing efficient regulatory strategies and using AI to compile and submit technical dossiers. Our services ensure your products meet all local standards for a faster path to market. 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 to learn how we can accelerate your global expansion.
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    3 分
  • Mexico's COFEPRIS Framework: A Deep Dive into the Ley General de Salud for Medical Devices

    Mexico's COFEPRIS Framework: A Deep Dive into the Ley General de Salud for Medical Devices
    2025/11/17
    This episode provides a comprehensive overview of Mexico's foundational health regulation, the Ley General de Salud, and its impact on medical device market access. We explore the role and authority of the regulatory body, COFEPRIS, and break down the key requirements manufacturers must meet, from pre-market registration and GMP compliance to post-market technovigilance and import controls. Key Questions - What is the Ley General de Salud and why is it critical for MedTech companies? - How does COFEPRIS regulate medical devices in Mexico? - What are the essential components of Mexico's regulatory framework for medical devices? - Are foreign manufacturers required to have a local representative in Mexico? - What are Norma Oficial Mexicana (NOMs) and how do they apply to manufacturing? - What is "technovigilance" and what are the post-market requirements? - Does Mexico have a risk-based classification system for medical devices? 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 tools. Our Market Access & Registration services help you identify the best markets, develop efficient regulatory strategies, and prepare technical dossiers for submission. Acting as your local representative in over 30 markets, we manage the entire registration process to get your product approved and ready for sale. Visit https://pureglobal.com/, email us at info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai to learn more.
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    3 分
  • Brazil GMP Certification: A Deep Dive into RDC 687/2022 for Class III/IV Devices

    Brazil GMP Certification: A Deep Dive into RDC 687/2022 for Class III/IV Devices
    2025/11/16
    This episode provides a detailed analysis of Brazil's RDC 687/2022, a critical regulation from ANVISA governing Good Manufacturing Practices (GMP) certification for Class III and IV medical device manufacturers. We explore the key requirements, audit procedures, and documentation needed to secure the mandatory CBPF certificate, highlighting the changes from the previous RDC 183/2017 and what international manufacturers must do to successfully enter the Brazilian market for high-risk devices. Key Questions: - What is ANVISA's RDC 687/2022 and who does it apply to? - How does this regulation impact manufacturers of Class III and IV medical devices? - What are the mandatory steps to obtain GMP certification in Brazil? - What replaced the previous RDC 183/2017 regulation, and when? - How long is the Brazilian GMP certificate valid for? - What kind of documentation is required for the submission to ANVISA? - Why is this certification a prerequisite for market entry in Brazil? Navigating regulations like Brazil's RDC 687/2022 is where Pure Global excels. We offer end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and AI tools. Our team acts as your local representative in Brazil and over 30 other markets, developing efficient pathways for ANVISA approval and using AI to compile technical dossiers. We manage submissions and ensure ongoing compliance so you can access markets faster. For comprehensive support, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 分