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 [email protected], or explore our FREE AI tools and database at https://pureglobal.ai.

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 [email protected], visit our website at https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

This episode provides a detailed overview of Colombia's medical device risk classification system as regulated by INVIMA under Decree 4725 of 2005. We explain the four-tiered risk classes (Class I, IIa, IIb, and III), the criteria used for classification such as invasiveness and duration of use, and how a device's class determines its regulatory pathway for market approval in this key Latin American market.

- What is the primary regulation governing medical device classification in Colombia?

- How does INVIMA define Class I, IIa, IIb, and III medical devices?

- What are the key factors used to determine a device's risk classification?

- Why is correct classification the most critical first step for market entry in Colombia?

- How does a device's risk class impact the INVIMA registration process and timeline?

- Which international classification models is Colombia's system harmonized with?

- Can you provide examples of devices for each of the four risk classes?

- What is the difference in the regulatory pathway for low-risk versus high-risk devices?

Pure Global offers end-to-end consulting to streamline your entry into over 30 global markets, including Colombia. Our local experts and advanced AI tools simplify complex regulatory challenges. We manage your technical dossier preparation, act as your official in-country representative for INVIMA, and develop a clear regulatory strategy to ensure your device meets all requirements under Decree 4725. With Pure Global, a single registration process can open doors to multiple markets, accelerating your global expansion efficiently. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI regulatory tools at https://pureglobal.ai.

This episode provides a comprehensive guide for foreign medical device manufacturers on registering their products in Colombia. We cover the role of the regulatory authority, INVIMA, the risk-based device classification system, and the essential documentation required for a successful submission, including the Certificate of Free Sale (CFS) and ISO 13485 certification. The host details the distinct timelines for low-risk and high-risk devices, explaining the expedited pathway for Class I and IIa products versus the more rigorous review for Class IIb and III devices.

- What is INVIMA's role in the Colombian medical device market?

- How does Colombia's risk-based classification system work?

- Why is a local legal representative mandatory for foreign manufacturers?

- What is a Certificate of Free Sale (CFS) and why is it essential?

- Do technical documents and labeling need to be in Spanish?

- What are the typical registration timelines for low-risk devices?

- How long does it take to register high-risk devices in Colombia?

- How long is a medical device registration valid for in Colombia?

Pure Global streamlines global market access for MedTech and IVD companies. Our experts act as your local representative in over 30 markets, including Colombia, managing the entire INVIMA registration process. We develop efficient regulatory strategies and use advanced AI to compile and submit your technical dossiers, minimizing delays and ensuring compliance. Let us help you navigate the requirements for the Certificate of Free Sale, quality system documentation, and local regulations to get your product to market faster. Contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools and database at https://pureglobal.ai.

This episode breaks down the critical responsibilities of Economic Operators—Manufacturer, Authorised Representative, Importer, and Distributor—and the Person Responsible for Regulatory Compliance (PRRC) under the EU's MDR and IVDR. We explore the common operational pitfalls, such as role confusion, misaligned contracts, and PRRC coverage gaps, that frequently lead to audit findings and can jeopardize your market access in the European Union.

Key Questions:

- What are the four legally distinct Economic Operators under the EU MDR?

- How do the responsibilities of an Importer differ from those of a Distributor?

- Who is required to appoint a Person Responsible for Regulatory Compliance (PRRC)?

- What are the primary duties of a PRRC in ensuring device compliance?

- How can poorly defined contracts between operators lead to audit failures?

- What are the risks of having a gap in your PRRC coverage?

- Why is the Authorised Representative essential for non-EU manufacturers?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We specialize in defining clear regulatory strategies, including the proper setup of economic operator roles and PRRC responsibilities to ensure EU MDR and IVDR compliance. Our experts act as your local representative in over 30 markets, managing technical dossiers and post-market surveillance. By combining local expertise with advanced AI tools, we help you navigate complex regulations efficiently. Need to align your compliance framework? Contact Pure Global at [email protected], visit us at https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.

This episode explores the growing tension between single-use medical devices and the push for sustainability. We delve into the complex world of reprocessing, examining the regulatory hurdles, validation requirements, and critical liability shifts under frameworks like the US FDA and the EU's Medical Device Regulation (MDR). We discuss how this trend impacts manufacturers, from Instructions for Use (IFU) to risk management, and what the future holds as the circular economy reshapes MedTech business models.

Key Questions:

- When is a single-use device no longer single-use?

- Who becomes the legal manufacturer when a device is reprocessed?

- What are the FDA and EU MDR requirements for device reprocessing?

- How does reprocessing impact liability for the original manufacturer?

- Why do Instructions for Use (IFU) need to be crystal clear about single-use claims?

- What validation is needed to prove a reprocessed device is safe and effective?

- How is the push for a circular economy changing medical device design and business strategy?

- What new risks must be considered when reprocessing a 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. Whether you're developing a regulatory strategy, compiling a technical dossier, or navigating post-market surveillance, our team can help. We act as your local representative in over 30 markets, using technology to accelerate approvals and ensure compliance. To access global markets faster and more efficiently, contact us at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.

This episode details the significant regulatory complexities for Companion Diagnostics (CDx) under the European Union's In Vitro Diagnostic Regulation (IVDR). We explore why these devices are now in a higher risk class, the impact of mandatory consultations with medicinal authorities like the EMA, and the critical need for seamless coordination between IVD manufacturers and their pharmaceutical partners to ensure timely market access.

Key Questions:

- What makes Companion Diagnostics (CDx) a unique challenge under the EU IVDR?

- Why are most CDx considered high-risk Class C devices?

- How does the mandatory consultation with the European Medicines Agency (EMA) impact timelines?

- What are the new clinical evidence requirements for CDx performance evaluation?

- How can IVD manufacturers and pharma partners align their regulatory strategies?

- What happens if the drug and device timelines are not synchronized?

- Why is early-stage coordination crucial for successful market entry?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We streamline global market access by combining local expertise in over 30 markets with advanced AI and data tools. Our services cover the entire lifecycle, from regulatory strategy and technical dossier submission to post-market surveillance. By leveraging a single registration process for multiple markets, we help you expand efficiently. Whether you're a startup or a multinational enterprise, our technology-driven solutions ensure compliance and speed. Contact Pure Global at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.

This episode demystifies the requirements for In-Vitro Diagnostic (IVD) performance studies under the EU's IVDR. We explore the crucial guidance document, MDCG 2025-5, published in June 2024, to clarify common points of confusion for manufacturers. We cover the key differences between study notifications and applications, what constitutes a 'substantial modification,' the rules for using leftover samples, and how to manage combined studies, helping you avoid costly delays and regulatory rework.

Key Questions:

- What is the difference between a performance study notification and an application under IVDR?

- When do I need to re-submit if I make changes to my study protocol?

- Can we use leftover patient samples for our IVD performance study?

- What does MDCG 2025-5 say about substantial modifications?

- How does the EU regulate studies combining an IVD and a medicinal product?

- Why is correctly classifying my IVD study crucial for avoiding delays?

- What are the documentation requirements for studies using archived samples?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. Our experts, backed by advanced AI tools, streamline global market access. We develop efficient regulatory strategies for performance studies and pre-submission activities to minimize rejections. Our team handles the compilation and submission of technical dossiers, ensuring compliance with complex regulations like the EU IVDR. Whether you're a startup or a multinational, Pure Global provides the local expertise and technology-driven solutions to get your product to market faster. Contact us at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.

This episode provides a detailed breakdown of the three pillars of performance evaluation required under the EU's In Vitro Diagnostic Regulation (IVDR): scientific validity, analytical performance, and clinical performance. We focus specifically on the heightened requirements and common pitfalls for manufacturers of high-risk Class C and D devices, explaining why underestimating the clinical evidence burden is a primary cause of delays in obtaining CE marking.

- What are the three essential pillars of a successful IVDR performance evaluation?

- Why is a Scientific Validity Report the foundational first step for your technical documentation?

- What specific data is required to demonstrate analytical performance under the new regulation?

- How has the burden for clinical performance evidence changed for Class C and D IVDs?

- What are the most common reasons for CE marking delays related to performance studies?

- How can you develop a robust clinical performance study plan that satisfies Notified Body scrutiny?

- What is the critical difference between analytical performance and clinical performance in the eyes of regulators?

Pure Global helps IVD companies conquer the challenges of global regulations like the EU IVDR. Our experts develop efficient regulatory strategies and manage the creation of technical dossiers, including complex Performance Evaluation Reports. We leverage advanced AI tools to streamline literature reviews and manage clinical data, ensuring your submission is robust and complete. Whether you're a startup or a multinational, we provide the support needed to navigate pre-submission activities and get your innovative IVDs to the European market faster. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

This episode delves into the critical requirements for medical device cybersecurity in the European Union. We explore the concept of "state of the art" as defined by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), focusing on the key guidance document, MDCG 2019-16 Rev. 1. Learn how this guidance impacts your design controls, risk management, post-market surveillance, and change management processes to avoid common and costly audit nonconformities.

- What does "state of the art" mean for medical device cybersecurity in the EU?

- Why is MDCG 2019-16 Rev. 1 a critical document for your technical file?

- How do you integrate "secure by design" principles into your product lifecycle?

- Are your post-market surveillance activities adequately addressing cybersecurity vulnerabilities?

- When does a cybersecurity patch trigger a significant change notification to your Notified Body?

- What are the most common cybersecurity-related nonconformities in MDR and IVDR audits?

- How does vulnerability handling connect to your vigilance reporting obligations?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers, ensuring compliance with complex requirements like cybersecurity. Our experts provide continuous regulatory monitoring to keep you ahead of changes that impact your market access. With a presence in over 30 markets, we act as your local representative, managing post-market surveillance and ensuring ongoing compliance. Let us help you navigate the global landscape. Contact us at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.