Episodios

  • ANVISA's Gateway to Brazil: Why Korean MFDS Approval is Non-Negotiable

    ANVISA's Gateway to Brazil: Why Korean MFDS Approval is Non-Negotiable
    Jan 14 2026
    This episode delves into the single most critical requirement for Korean medical device manufacturers entering the Brazilian market: providing proof of country of origin market authorization. We explain why Brazil's ANVISA requires official approval from Korea's Ministry of Food and Drug Safety (MFDS) and how this documentation serves as vital evidence of a device's safety and efficacy. We also explore the direct impact that your domestic regulatory timeline in Korea has on your ability to access the Brazilian market, highlighting the need for a coordinated global registration strategy. Key Questions: - What is the most important document for a Korean MedTech company entering Brazil? - How does Brazil's ANVISA verify the safety of foreign medical devices? - Why is your Korean MFDS approval critical for Brazilian market entry? - Can you register a device in Brazil without approval in its home country? - How can delays in your Korean registration impact your global expansion plans? - What strategic considerations must Korean manufacturers make when planning for Brazilian market access? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies seeking to access new international markets like Brazil. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers for ANVISA registration, ensuring your Korean MFDS approval is leveraged effectively. We act as your local representative, managing the entire process to get your product approved faster. Explore our free regulatory AI tools and database at https://pureglobal.ai, or contact us at info@pureglobal.com and visit https://pureglobal.com to accelerate your global expansion.
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    3 m
  • Brazil's INMETRO Certification: A Guide for Korean Electro-Medical Device Manufacturers

    Brazil's INMETRO Certification: A Guide for Korean Electro-Medical Device Manufacturers
    Jan 13 2026
    This episode focuses on a critical regulatory hurdle for Korean medical device companies entering the Brazilian market: the mandatory INMETRO certification for electro-medical devices. We break down why this certification, which requires local testing in Brazil, is often an unexpected challenge for manufacturers accustomed to the MFDS system. We cover the specific devices affected, the typical timelines of three to twelve months, and the ongoing costs associated with maintenance audits, providing a clear overview of this significant market access barrier. Key Questions: - What is INMETRO certification and why is it mandatory for certain medical devices in Brazil? - How does Brazil's local testing requirement differ from the process recognized by Korea's MFDS? - Which international standard, IEC 60601, triggers the need for INMETRO certification? - What is the expected timeline for achieving this certification, from start to finish? - Are there ongoing costs and audits required to maintain INMETRO certification after approval? - Why must Korean companies budget for this as a separate, significant market access expense? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and advanced AI. Whether you're navigating Brazil's INMETRO certification or entering any of our 30+ markets, our team provides comprehensive support from regulatory strategy and technical dossier submission to post-market surveillance. We act as your local representative, ensuring a smooth path to market. To accelerate your global expansion and leverage our powerful AI and data tools, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free resources at https://pureglobal.ai.
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    3 m
  • Cracking the Code: Brazil's Complex Import Taxes for Korean MedTech

    Cracking the Code: Brazil's Complex Import Taxes for Korean MedTech
    Jan 12 2026
    This episode delves into the single most significant barrier for Korean medical device manufacturers entering the Brazilian market: the intricate and burdensome import taxation system. We break down the multiple federal and state-level taxes—including II, IPI, PIS, COFINS, and ICMS—that can collectively exceed 60% of a product's value, and explain why a nuanced understanding of landed costs and product classification is essential for success. - Why is Brazil's import tax system so challenging for Korean MedTech companies? - What are the five key taxes levied on imported medical devices in Brazil? - How can the total tax burden impact the competitiveness of your product? - Why does the importing state in Brazil change the final cost of your device? - What is a 'landed cost' and why is it critical to calculate it accurately? - How does Brazil's tax structure differ from Korea's import duties? - What strategic adjustments must Korean companies make to their pricing for the Brazilian market? Pure Global provides end-to-end regulatory consulting for MedTech and IVD firms, streamlining global market access with local expertise and advanced AI. We help you develop efficient regulatory strategies, manage technical dossier submissions, and navigate complex markets like Brazil. Our services include acting as your local representative in over 30 countries and ensuring continuous regulatory monitoring. By integrating technology and deep market knowledge, we help you overcome barriers and accelerate your entry into new territories. For a strategic partner in your global expansion, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools at https://pureglobal.ai.
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    3 m
  • Brazil's ANVISA: The Portuguese Language Barrier for Korean MedTech

    Brazil's ANVISA: The Portuguese Language Barrier for Korean MedTech
    Jan 11 2026
    This episode details the single most critical challenge for Korean medical device manufacturers entering Brazil: ANVISA's strict Portuguese-only documentation requirement. We explore why this is a major hurdle, how it differs from Korea's MFDS policies, and the significant risks of improper translation, including costly delays and registration failures. Key Questions: - Why is entering the Brazilian market uniquely challenging for Korean medical device companies? - What is ANVISA's strictest documentation requirement for all submissions? - How does Brazil's language policy for medical devices differ from Korea's MFDS? - What are the primary risks of improper translation for ANVISA submissions? - Why do general translation services often fail for MedTech regulatory documents? - What specific expertise is needed to successfully translate a technical dossier for Brazil? - How can Korean firms avoid costly delays and rejections related to documentation? Pure Global provides end-to-end regulatory solutions to help MedTech and IVD companies navigate complex market access challenges. Our team acts as your local representative in Brazil, ensuring all submissions meet ANVISA's stringent requirements. We leverage advanced AI tools to efficiently compile and manage technical dossiers, combined with expert review to ensure every document is accurately translated and compliant. This integrated approach streamlines your path to market, minimizing delays and costs. To learn how we can accelerate your entry into Brazil and over 30 other markets, 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 m
  • Korean MedTech in Brazil: Navigating ANVISA's B-GMP Certification

    Korean MedTech in Brazil: Navigating ANVISA's B-GMP Certification
    Jan 10 2026
    This episode unpacks the most critical step for Korean medical device companies entering the Brazilian market: ANVISA's Brazilian GMP (B-GMP) certification. We detail the mandatory B-GMP requirements for Class III and IV devices and compare the two main compliance pathways. Discover the significant time and cost advantages of leveraging MDSAP certification, which can extend certificate validity to four years and potentially waive on-site inspections, versus the timeline and costs associated with a direct ANVISA audit at your Korean facility. We also explain how to use your existing K-GMP certification as a strong foundation for B-GMP readiness. - What is B-GMP and why is it essential for selling high-risk medical devices in Brazil? - How can MDSAP certification streamline the ANVISA approval process for Korean manufacturers? - What are the potential time and cost savings of using the MDSAP pathway for B-GMP? - What does the B-GMP process look like for companies without MDSAP certification? - How long does a direct ANVISA on-site audit in Korea typically take? - Can my existing K-GMP certification help me achieve B-GMP compliance? - What is the validity period for a B-GMP certificate obtained through MDSAP versus a direct audit? 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 Brazil, developing efficient regulatory strategies and using advanced AI to compile technical dossiers. Our integrated approach allows a single registration process to access multiple markets. Whether you're a startup or a multinational, we help you navigate complex requirements like ANVISA's B-GMP. Visit us at https://pureglobal.com, email info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai to accelerate your market entry.
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    3 m
  • Korean MedTech in Brazil: Unlocking ANVISA Approval with a Brazilian Registration Holder (BRH)

    Korean MedTech in Brazil: Unlocking ANVISA Approval with a Brazilian Registration Holder (BRH)
    Jan 9 2026
    This episode explores the single most critical regulatory requirement for Korean medical device companies entering the Brazilian market: the mandatory appointment of a Brazilian Registration Holder (BRH). We delve into why foreign companies cannot register directly with ANVISA, contrast Brazil's system with Korea's MFDS, and outline the extensive legal and operational responsibilities of a BRH, from registration and GMP inspections to post-market surveillance. Learn why selecting the right local partner is essential for your success in Brazil. Key Questions: - What is a Brazilian Registration Holder (BRH) and why is it mandatory for market entry? - How does Brazil's ANVISA registration process differ from Korea's MFDS system for foreign manufacturers? - Can a Korean medical device company register its product in Brazil without a local representative? - What are the key legal responsibilities of a BRH in Brazil? - How does the BRH manage GMP inspections and post-market surveillance? - Why is cultural and regulatory understanding crucial when selecting a BRH partner? - What are the risks of choosing the wrong local representative in Brazil? Navigating complex markets like Brazil requires expert local knowledge. Pure Global provides end-to-end regulatory solutions for MedTech and IVD companies, acting as your local representative and Brazilian Registration Holder (BRH) to streamline market access. Our team of in-country experts, supported by advanced AI tools, manages everything from initial regulatory strategy and technical dossier submission to post-market surveillance. We bridge the gap between your company and ANVISA, ensuring a compliant and efficient path to market. 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 m
  • EU MDR Clinical Investigations: Navigating Deadlines and Data Requirements for European Market Access

    EU MDR Clinical Investigations: Navigating Deadlines and Data Requirements for European Market Access
    Jan 8 2026
    This episode provides a detailed overview of the clinical investigation requirements under the European Union's Medical Device Regulation (MDR). We explore the critical distinctions between pre-market clinical investigations and post-market clinical follow-up (PMCF), the role of the Clinical Evaluation Report (CER) as a living document, and the key transitional deadlines that manufacturers of legacy devices must meet to maintain market access. We also touch on the function of the EUDAMED database in enhancing transparency. - What are the primary differences between clinical data requirements under the old MDD and the current MDR? - How does the MDR define a pre-market clinical investigation versus a post-market clinical follow-up (PMCF) study? - What were the critical compliance actions required by the May 26, 2024, deadline for legacy devices? - What is the significance of the September 26, 2024, deadline for agreements with Notified Bodies? - Why is the Clinical Evaluation Report (CER) now considered a living document that requires continuous updates? - What are the final transition deadlines for different device risk classes to become fully MDR compliant? - How will the EUDAMED database impact the transparency of clinical investigations in the EU? - What are the general requirements for reporting serious adverse events during a clinical investigation under the MDR? Navigating the EU MDR's stringent clinical evidence requirements demands deep regulatory expertise. Pure Global provides 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, use AI to compile technical dossiers, and act as your local representative to ensure you meet all pre-market and post-market obligations. To learn how we can accelerate your entry into over 30 global markets, 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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    4 m
  • Navigating COFEPRIS: A Guide to Dental Device Registration and Market Access in Mexico

    Navigating COFEPRIS: A Guide to Dental Device Registration and Market Access in Mexico
    Jan 7 2026
    This episode provides a comprehensive guide to the regulatory landscape for dental devices in Mexico. We delve into the role of the national regulatory body, COFEPRIS, and explore the classification system for dental equipment and supplies. The discussion covers the essential requirements for market entry, including the mandatory appointment of a Mexican Registration Holder (MRH), the different registration pathways available—such as the Standard and Equivalency routes—and the critical importance of post-market technovigilance for maintaining compliance. Key Questions: - What is COFEPRIS and what is its role in regulating dental devices in Mexico? - How are dental devices classified according to risk in the Mexican market? - What is a Mexican Registration Holder (MRH) and why is it essential for foreign manufacturers? - What are the primary regulatory pathways for getting a dental device approved in Mexico? - Can approvals from the FDA or Health Canada expedite the registration process in Mexico? - What are the post-market surveillance and technovigilance requirements? - How often do sanitary registrations need to be renewed? - What recent regulatory updates impact dental device registration in Mexico? 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. We act as your local representative in over 30 markets, developing efficient regulatory strategies and using AI to compile and submit technical dossiers. Our services ensure your products get to market faster and maintain compliance. For startups, scaleups, or multinational enterprises, Pure Global provides tailored solutions to navigate complex regulatory environments. 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 m
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