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PODCAST

Medical Device Global Market Access

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

technology

All Episodes

03:12

Beyond the Clinical Trial: Unlocking MedTech Market...

Medical Device Global Market Access ·

2026/03/06

This episode explores the pivotal shift from traditional clinical trial data to the increasing demand for continuous Real-World Evidence (RWE) for medical devices. We delve into why global regulators and payers now require robust post-market data to prove a device's long-term safety, effectiveness, and value. We also unpack the significant infrastructure and analytical challenges that MedTech companies face in building a compliant and effective RWE program.Key Questions: - What is the difference

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03:16

EU AI Act: Navigating High-Risk Classification & Dual...

Medical Device Global Market Access ·

2026/03/05

This episode delves into the EU's new Artificial Intelligence Act and its significant impact on medical device manufacturers. We explore the "high-risk" classification for most AI-driven medical devices, the new compliance obligations that run parallel to existing MDR/IVDR requirements, and the critical timelines manufacturers must meet. We break down the challenges and strategies for navigating this dual regulatory framework, from data governance to human oversight.- What is the EU AI Act and why

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03:21

FDA's QMSR Shift: Harmonizing US Quality Systems with...

Medical Device Global Market Access ·

2026/03/04

This episode breaks down the FDA's final rule transitioning the Quality System Regulation (21 CFR Part 820) to the ISO 13485-aligned Quality Management System Regulation (QMSR). We cover the February 2, 2026, compliance deadline, the key differences and retained FDA requirements, and the strategic steps medical device manufacturers must take to harmonize their global quality documentation and ensure a seamless transition.- What is the FDA's new Quality Management System Regulation (QMSR)? - When

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03:24

EU MDR Compliance: Surviving the Notified Body...

Medical Device Global Market Access ·

2026/03/03

This episode delves into the critical capacity crisis among Notified Bodies under the EU's Medical Device Regulation (MDR). We explore how the stringent requirements of the MDR, combined with a reduction in the number of designated Notified Bodies, have created a massive bottleneck for certifying new and legacy medical devices. We discuss the significant risk this poses to manufacturers, who face the possibility of their products being forced off the market as old certificates expire, and examine

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03:12

Countdown to EUDAMED: Mastering the EU's May 2026...

Medical Device Global Market Access ·

2026/03/02

This episode dives into one of the most significant challenges facing medical device manufacturers in 2026—the mandatory EUDAMED registration deadline. We break down what the May 2026 milestone means, the complexities of uploading technical and Unique Device Identification (UDI) data, and the critical steps companies must take now to avoid being locked out of the European Union market. Key Questions: - What is the EUDAMED and why is it critical for EU market access? - When is the final deadline for

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03:20

Singapore HSA Fees: A Cost Breakdown for Class B, C,...

Medical Device Global Market Access ·

2026/03/01

This episode provides a detailed breakdown of the medical device registration fees charged by Singapore's Health Sciences Authority (HSA). We cover the standard application fee and the specific evaluation costs for Class B, Class C, and Class D devices. The host explains how different evaluation routes—such as Full, Abridged, Expedited, and Immediate—impact the final cost and how leveraging prior approvals from reference agencies can lead to significant savings. - What are the latest HSA

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02:51

Singapore MedTech Compliance: Mastering the SS 620...

Medical Device Global Market Access ·

2026/02/28

This episode provides a detailed overview of Singapore's mandatory Good Distribution Practice for Medical Devices (GDPMDS) certification. We explore the governing standard, SS 620:2016, and explain why it is an essential requirement enforced by the Health Sciences Authority (HSA) for any company seeking to import or wholesale medical devices in this key Asian market. Learn about the core components of the standard, from quality management systems to traceability and storage, to ensure your supply

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03:07

Singapore MedTech Market: A Guide to HSA's Importer,...

Medical Device Global Market Access ·

2026/02/27

This episode provides a detailed guide to the three types of medical device dealer licenses required by Singapore's Health Sciences Authority (HSA): manufacturer, importer, and wholesaler. We clarify the specific activities each license permits and highlight the critical, non-negotiable requirement for a compliant Quality Management System (QMS), referencing key standards like GDPMDS and ISO 13485.- What are the three types of dealer licenses for medical devices in Singapore? - If I import a

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03:04

Navigating Singapore's HSA: The Class A Medical...

Medical Device Global Market Access ·

2026/02/26

This episode delves into a key regulatory pathway in Singapore for low-risk medical devices. We explore the Health Sciences Authority's (HSA) exemption from product registration for Class A non-sterile devices, a crucial topic clarified by guidance from June 1, 2022. We detail the specific requirements that are waived, as well as the crucial obligations that remain, such as dealer licensing and post-market surveillance. This is essential listening for any MedTech company looking to enter the

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02:52

Unlocking Singapore: Mastering the ASEAN CSDT for...

Medical Device Global Market Access ·

2026/02/25

This episode provides a detailed guide on using the ASEAN Common Submission Dossier Template (CSDT) for medical device registration in Singapore. We cover the structure of the CSDT, specific documentation required by Singapore's Health Sciences Authority (HSA), and how requirements vary based on device risk classification, ensuring you have the information to prepare a successful submission.- What is the ASEAN Common Submission Dossier Template (CSDT)? - How does the CSDT streamline medical device

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02:45

Singapore HSA Fast-Track: Leveraging FDA, CE Mark &...

Medical Device Global Market Access ·

2026/02/24

This episode explores Singapore's Health Sciences Authority (HSA) abridged evaluation route, a streamlined pathway for medical device registration. We detail how manufacturers can leverage prior approvals from five major reference agencies—including the US FDA and EU Notified Bodies—to accelerate market access for Class B, C, and D devices in this key ASEAN hub. - What are Singapore's five reference regulatory agencies for medical devices? - How can a US FDA approval or EU CE Mark speed up your

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02:58

Singapore MedTech Compliance: Navigating HSA...

Medical Device Global Market Access ·

2026/02/23

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

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03:14

Singapore HSA Pathways: A Guide to Immediate,...

Medical Device Global Market Access ·

2026/02/22

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

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03:21

Singapore HSA: A Guide to Medical Device Risk...

Medical Device Global Market Access ·

2026/02/21

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

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02:55

Singapore Medical Device Registration: Navigating the...

Medical Device Global Market Access ·

2026/02/20

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

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02:58

Navigating INVIMA: Colombian Rules for Medical Device...

Medical Device Global Market Access ·

2026/02/19

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

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03:11

Colombia's INVIMA Medical Device Registration: A...

Medical Device Global Market Access ·

2026/02/18

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

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03:05

Colombia's INVIMA Registration: Is FDA or CE Mark...

Medical Device Global Market Access ·

2026/02/17

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)

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03:10

Colombia INVIMA Medical Device Registration:...

Medical Device Global Market Access ·

2026/02/16

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

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03:07

Colombia's INVIMA Approval Timelines: Standard vs....

Medical Device Global Market Access ·

2026/02/15

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

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