Medical Device Global Market Access

Pure Global
  • 5.0 (1)
  • TECHNOLOGY

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.

  1. 22H AGO

    Singapore HSA: A Guide to Medical Device Risk Classification (Class A-D)

    This episode provides a detailed guide to Singapore's Health Sciences Authority (HSA) medical device risk classification system. We explore the four-tier structure (Class A to Class D), explain how it aligns with international GHTF/IMDRF principles, and discuss how factors like intended use and invasiveness determine a device's class. Understanding this foundational step is crucial as it dictates the entire regulatory pathway for market access in Singapore. Key Questions: - What are the four risk classes for medical devices in Singapore? - How does the HSA classify a device based on its intended use and technology? - Why is Singapore's system aligned with global standards like the GHTF? - What are some examples of Class A, B, C, and D devices? - How does risk classification impact the registration process and timeline? - What are the consequences of incorrectly classifying your medical device? - Which devices might be exempt from pre-market registration in Singapore? Navigating Singapore's regulatory landscape requires local expertise and strategic planning. Pure Global specializes in helping MedTech and IVD companies achieve market access in over 30 countries, including key Asia Pacific markets like Singapore. Our experts develop efficient regulatory strategies, manage technical dossier submissions, and act as your local representative. By leveraging advanced AI and data tools, we streamline the process, ensuring your device is classified correctly and your submission is optimized for success. Contact Pure Global at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai to accelerate your global expansion.

    3 min

  2. 1D AGO

    Singapore Medical Device Registration: Navigating the HSA & Health Products Act

    This episode provides a detailed overview of Singapore's medical device registration framework. We cover the role of the Health Sciences Authority (HSA), the foundational Health Products Act 2007 and Medical Devices Regulations 2010, the four-tiered risk classification system, and the various registration pathways available to manufacturers based on prior approvals in reference markets. - What is the primary legislation governing medical devices in Singapore? - How does the Health Sciences Authority (HSA) classify medical devices by risk? - What are the different registration pathways available for market entry? - Which countries are considered reference markets by the HSA? - Can approval from another country speed up your Singapore registration? - What is the ASEAN CSDT and why is it important for your submission? - Is a local representative required to register a medical device in Singapore? - Are all device classes required to undergo full product registration? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We leverage local expertise and advanced AI tools to streamline global market access, acting as your local representative in over 30 markets, including Singapore. Our services cover the entire product lifecycle, from regulatory strategy and technical dossier submission to post-market surveillance. Let us help you navigate complex frameworks efficiently. For more information, visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.

    3 min

  3. 2D AGO

    Navigating INVIMA: Colombian Rules for Medical Device Labeling, IFU, and Spanish Translation

    This episode provides a detailed overview of the regulatory requirements for medical device labeling, Instructions for Use (IFU), and Spanish translation for market entry into Colombia. We explore the specific rules set by the national authority, INVIMA, and explain how these elements are meticulously evaluated during the registration process to ensure patient safety and device efficacy. - What is INVIMA's primary language requirement for medical device labels in Colombia? - Which Colombian decree governs the rules for labeling and IFUs? - How does an inaccurate Spanish translation affect the device registration timeline? - What specific information must be included on a label for the Colombian market? - Why is a professional, technical translation of the IFU so critical for approval? - What are the most common pitfalls manufacturers face with labeling submissions to INVIMA? - How does INVIMA verify the accuracy of translated materials? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We specialize in navigating complex requirements like those in Colombia, acting as your local representative in over 30 markets. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers, minimizing rejections. From initial market research to post-market surveillance, Pure Global ensures your products meet all local standards for a faster 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.

    3 min

  4. 3D AGO

    Colombia's INVIMA Medical Device Registration: A Breakdown of Government Fees and Ongoing Costs

    This episode provides a detailed breakdown of the costs associated with registering a medical device in Colombia with the regulatory authority, INVIMA. We cover the official government application fees based on risk classification, as well as essential ongoing costs such as renewals, modification fees, and the expenses related to local representation and translation services, giving you a complete financial picture for market entry. - What are the official INVIMA government fees for medical device registration in Colombia? - How does the risk class of a device affect the registration cost? - Are there costs other than the government application fees? - What are the ongoing maintenance costs for a medical device registration in Colombia? - How much are renewal fees and how often are they required? - Do I need to budget for translation services? - Is a local legal representative required and what are the associated costs? - What happens if I need to make a modification to my registered device? 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 Colombia, developing efficient regulatory strategies and using advanced AI to compile and submit technical dossiers. Our services ensure ongoing compliance through post-market surveillance and continuous regulatory monitoring. By integrating local expertise with data-driven tools, we help you navigate complex environments and expand your global footprint. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

    3 min

  5. 4D AGO

    Colombia's INVIMA Registration: Is FDA or CE Mark Approval a Must?

    This episode explores the requirements for medical device registration in Colombia, focusing on whether prior approval from a reference country like the US or EU is mandatory. We detail the role of a Certificate of Free Sale (CFS), the different regulatory pathways defined by INVIMA based on device risk classification (Class I, IIa, IIb, III), and the specific process available for novel devices that have not yet received marketing authorization in any country. - Is a Certificate of Free Sale (CFS) mandatory for medical device registration in Colombia? - Which countries does INVIMA recognize as reference markets for prior approval? - How does device risk class affect the registration timeline and process in Colombia? - Can you register a novel medical device in Colombia without FDA approval or a CE mark? - What is the difference between INVIMA's "automatic" and "controlled" review pathways? - What is the function of INVIMA's Medical Device Reviewing Commission? - Are the requirements the same for both low-risk and high-risk devices? - What key decree governs medical device registration in Colombia? Pure Global provides comprehensive solutions for MedTech and IVD companies seeking to enter or expand in over 30 global markets, including Colombia. Our local experts and advanced AI tools streamline the entire process, from developing a regulatory strategy and compiling technical dossiers to acting as your official in-country legal representative. We accelerate market access and ensure ongoing compliance, allowing you to reach patients faster. Discover our free AI-powered regulatory tools and database at https://pureglobal.ai, or contact us at info@pureglobal.com and visit https://pureglobal.com to learn how we can support your global expansion.

    3 min

  6. 5D AGO

    Colombia INVIMA Medical Device Registration: Technical Files, CFS, and Apostille Requirements

    This episode provides a detailed guide on the essential documents required for medical device registration in Colombia through the regulatory body, INVIMA. We cover the critical importance of the Certificate of Free Sale (CFS), the specific requirements for legalization and apostilles, the necessity of a local legal representative, and the comprehensive components of the technical file, including the mandatory Spanish language requirement. - What is the role of INVIMA in Colombia's medical device approval process? - Why is a Certificate of Free Sale (CFS) a mandatory document for registration? - What is an apostille, and when is it required for your submission documents? - Do foreign manufacturers need a local representative in Colombia? - What key information must be included in the technical file for INVIMA? - Is it possible to submit documents in English, or is Spanish mandatory? - What are the requirements for device labeling and Instructions for Use (IFU)? - How long is a medical device registration valid in Colombia? Pure Global offers expert regulatory consulting to streamline your MedTech or IVD company's entry into complex markets like Colombia. Our team acts as your local representative, leveraging in-country expertise and advanced AI tools to manage technical dossier submissions and ensure compliance with INVIMA's stringent requirements. We handle everything from regulatory strategy to post-market surveillance, allowing you to access over 30 global markets with a single, efficient process. 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 accelerate your global expansion.

    3 min

  7. 6D AGO

    Colombia's INVIMA Approval Timelines: Standard vs. Expedited Medical Device Pathways

    This episode explores the medical device registration process in Colombia, focusing on the timelines set by the regulatory authority, INVIMA. We break down the key differences between the standard (controlled) review pathway for high-risk devices and the expedited (automatic) process for lower-risk devices, including eligibility requirements and realistic time-to-market estimates for each. This is essential information for any MedTech company considering market entry into Colombia. - What is INVIMA and what is its role in regulating medical devices in Colombia? - How long does the standard review process for Class IIb and III medical devices typically take? - What is the expedited or automatic registration pathway in Colombia? - Which device classes are eligible for the faster, automatic registration process? - What is a Certificate of Free Sale and why is it crucial for expedited entry? - Which foreign approvals does INVIMA recognize for its fast-track process? - How can manufacturers leverage existing FDA or CE approvals to speed up Colombian registration? - What are the realistic, real-world timelines for both the standard and expedited pathways? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies entering markets like Colombia. Our experts develop efficient regulatory strategies, leveraging pathways like INVIMA's automatic registration to accelerate your time-to-market. We manage the entire process, from compiling the technical dossier with AI-powered tools to acting as your local legal representative. With a presence in over 30 markets, we can turn a single registration process into multi-market access. To learn how we can help your company 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.

    3 min

  8. FEB 14

    Colombia's INVIMA Regulations: Legal Representative Duties for Medical Device Registration

    This episode details the mandatory requirement for a local authorized representative for medical device registration in Colombia. We explore the legal responsibilities this representative assumes as stipulated by the regulatory authority, INVIMA, under Decree 4725 of 2005. The discussion covers their central role in registration, post-market surveillance (technovigilance), and communication with authorities, while also highlighting the strategic importance of choosing an independent representative over a distributor to maintain market control. - Is a local representative required to sell medical devices in Colombia? - What are the specific legal duties mandated by INVIMA for this representative? - Who legally holds the product registration in Colombia—the manufacturer or the local representative? - What is the difference between a legal representative and an importer in Colombia? - How is post-market surveillance, or technovigilance, managed by the representative? - Which Colombian decree establishes the requirement for a local representative? - What are the risks of appointing a commercial distributor as your legal representative? - Why is selecting an independent third-party representative often the better long-term strategy? Pure Global offers end-to-end solutions for MedTech and IVD companies, streamlining global market access. We act as your local legal representative in over 30 countries, including Colombia, managing your registration submissions and ensuring ongoing compliance. Our experts, backed by advanced AI tools, help you develop efficient regulatory strategies, prepare technical dossiers, and monitor post-market activities. This integrated approach allows you to access multiple markets through a single, efficient process, saving time and resources. 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.

    3 min
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About

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.

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