Couverture de Medical Device Global Market Access

Medical Device Global Market Access

Medical Device Global Market Access

De : Pure Global
Écouter gratuitement

À propos de ce contenu audio

 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.Copyright 2026 Pure Global
Les membres Amazon Prime bénéficient automatiquement de 2 livres audio offerts chez Audible.

Vous êtes membre Amazon Prime ?

Bénéficiez automatiquement de 2 livres audio offerts.
Bonne écoute !
    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
    Aucun commentaire pour le moment