Épisodes

  • Singapore MedTech Compliance: Navigating HSA Registrant & Representative Roles

    Singapore MedTech Compliance: Navigating HSA Registrant & Representative Roles
    Feb 23 2026
    This episode details the mandatory requirement for foreign medical device manufacturers to appoint a Singapore Registrant. We explain the role and responsibilities of this local authorized representative as required by the Health Sciences Authority (HSA), the strategic implications of choosing a representative, and how it impacts market access for Class B, C, and D devices. - What is a Singapore Registrant and why is it mandatory for foreign manufacturers? - Who is eligible to act as a local authorized representative in Singapore? - What are the key legal responsibilities of the company holding the device license? - How does the Registrant control your medical device registration and market access? - Should your distributor also be your Singapore Registrant? - What happens to your HSA registration if you decide to change distributors? - Which medical device risk classes require the appointment of a local Registrant? Pure Global offers expert, independent local representation to act as your Singapore Registrant, ensuring you maintain full control over your device licenses. Our services streamline the HSA registration process, from compiling technical dossiers using advanced AI to managing post-market surveillance. By separating regulatory ownership from distribution, we provide MedTech and IVD companies with the flexibility to scale their business in Singapore and beyond. To secure your market access and build a resilient regulatory strategy, contact us at info@pureglobal.com, visit https://pureglobal.com/, or explore our FREE AI tools at https://pureglobal.ai/.
    Afficher plus Afficher moins
    3 min
  • Singapore HSA Pathways: A Guide to Immediate, Expedited & Abridged MedTech Registration

    Singapore HSA Pathways: A Guide to Immediate, Expedited & Abridged MedTech Registration
    Feb 22 2026
    This episode provides a detailed guide to the Singapore Health Sciences Authority (HSA) medical device registration pathways for Class B, C, and D devices. We explore the four main evaluation routes—Full, Abridged, Expedited, and Immediate—and explain how leveraging prior approvals from key international reference agencies like the US FDA and EU Notified Bodies can significantly accelerate your product's entry into the Singaporean market. - What are Singapore's four main evaluation routes for medical devices? - How can a US FDA approval or CE Mark speed up your HSA registration? - Which pathway is required for a novel device with no other market approvals? - What are the specific criteria for the Abridged route for Class B, C, and D devices? - Can your high-risk Class C or D device qualify for an Expedited review? - What are the requirements to get a Class B device registered almost immediately? - Which five global regulatory bodies does Singapore's HSA recognize? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We act as your local representative in over 30 markets, developing efficient regulatory strategies to get your product approved faster. Our advanced AI and data tools streamline the compilation and submission of technical dossiers, helping you identify the best markets for expansion. Whether you are a startup or a multinational, our integrated approach allows a single registration process to access multiple markets, combining global reach with local expertise. Contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our FREE AI tools at https://pureglobal.ai.
    Afficher plus Afficher moins
    3 min
  • Singapore HSA: A Guide to Medical Device Risk Classification (Class A-D)

    Singapore HSA: A Guide to Medical Device Risk Classification (Class A-D)
    Feb 21 2026
    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.
    Afficher plus Afficher moins
    3 min
  • Singapore Medical Device Registration: Navigating the HSA & Health Products Act

    Singapore Medical Device Registration: Navigating the HSA & Health Products Act
    Feb 20 2026
    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.
    Afficher plus Afficher moins
    3 min
  • Navigating INVIMA: Colombian Rules for Medical Device Labeling, IFU, and Spanish Translation

    Navigating INVIMA: Colombian Rules for Medical Device Labeling, IFU, and Spanish Translation
    Feb 19 2026
    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.
    Afficher plus Afficher moins
    3 min
  • Colombia's INVIMA Medical Device Registration: A Breakdown of Government Fees and Ongoing Costs

    Colombia's INVIMA Medical Device Registration: A Breakdown of Government Fees and Ongoing Costs
    Feb 18 2026
    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.
    Afficher plus Afficher moins
    3 min
  • Colombia's INVIMA Registration: Is FDA or CE Mark Approval a Must?

    Colombia's INVIMA Registration: Is FDA or CE Mark Approval a Must?
    Feb 17 2026
    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.
    Afficher plus Afficher moins
    3 min
  • Colombia INVIMA Medical Device Registration: Technical Files, CFS, and Apostille Requirements

    Colombia INVIMA Medical Device Registration: Technical Files, CFS, and Apostille Requirements
    Feb 16 2026
    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.
    Afficher plus Afficher moins
    3 min