Explore Our Videos
Join us for a series of videos and webinars focused on MedTech regulations, compliance, and innovation.
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Understand FDA small business qualification, reduced device user fees and the determination process discussed in this video.
Learn about Peru's medical device registration routes and the DIGEMID review times and fees covered in this video.
Explore South Korea's device classes, MFDS registration routes, review clocks and five-year renewal.
An introduction to the EU MDR clinical evaluation report, evidence requirements and keeping the CER up to date.
Learn when an EU authorized representative is needed and what MDR and IVDR Article 11 require.
Explore IVDR classification, Annex VIII rules and the legacy IVD transition deadlines covered in this video.
Understand the PRRC role under EU MDR and IVDR Article 15, including qualifications and responsibilities.
Learn how the 22 Annex VIII rules determine EU MDR device classes and how to apply the strictest relevant rule.
A video guide to NMPA device classes, registration routes, review clocks and China's medical device GMP framework.
Explore Hong Kong's MDACS listing framework, the CMPR and the changes covered in this video.
Learn when a device may need FDA premarket approval and how PMA evidence, fees and review clocks fit together.
Understand the Philippine FDA's CMDN and CMDR pathways and the registration changes discussed in this video.
A guide to post-market clinical follow-up under the EU MDR, including PMCF plans, evaluation reports and timing.
Learn how to use NANDO to check a notified body's designation and scope for your device under the EU MDR.
Find out what an FDA Certificate to Foreign Government covers, when exporters may need it and how requests work.
Explore substantial equivalence, predicates, eSTAR and the FDA 510(k) submission fees discussed in this video.
Understand FDA Pre-Sub meetings, Q-Submission types, timelines and how to prepare focused questions.
Learn how investigational device exemptions apply to device studies, risk determinations and FDA approval.
An overview of 21 CFR 803, medical device reporting deadlines, five-day reports and electronic MDR submissions.
Learn what the EU Medical Device Coordination Group does and how its guidance supports MDR and IVDR implementation.
Meet Vietnam's IMDA and explore medical device classes A–D, registration routes and fees.
Understand Form 483 observations, response timing, warning letters and FDA inspection outcomes.
A guide to the MHRA, UK medical device regulation and the CE and UKCA marking pathways discussed in this video.
Learn when a connected medical device may need ANATEL radio homologation in Brazil and what the process involves.
An introduction to FDA and CDRH, medical device risk classes, submission routes and user fees.
Understand MDEL and MDL, Canada's medical device classes and the licensing fees covered in this video.
Explore the sixth edition of ISO 10993-1, biological evaluation and the FDA transition discussed in this video.
Learn what Australia's ARTG covers and how device sponsors, registration and TGA fees fit together.
An overview of Malaysia's Medical Device Authority, device registration, local representation and Class A fees.
A video guide to Japan's PMDA, device classes, notification, certification, ministry approval and review timelines.
The resolution took effect in March twenty twenty-three.
The Saudi Food and Drug Authority regulates medical devices and in vitro diagnostics.
HSA is Singapore’s Health Sciences Authority.
Issued in two thousand five, the decree governs medical devices for human use in Colombia.
The standard specifies symbols for information supplied with medical devices.
COFEPRIS is Mexico’s federal health-risk regulator under the Ministry of Health.
The Thai FDA regulates health products under the Ministry of Public Health.
MHLW is Japan’s Ministry of Health, Labour and Welfare.
ANVISA is Brazil’s health regulatory agency.
INVIMA is Colombia’s national health-product regulator.
Watch how Mexico’s General Health Law connects to COFEPRIS, device registration and three practical checks for medical device teams.
This video walks you through the complete FDA registration process for medical devices in the United States, from classification and documentation to appointing a US Agent and submitting your application. Learn how to navigate the world’s largest medtech market, where over 40% of global device sales take place, and where FDA clearance sets the global standard. Whether you’re a first-time entrant or expanding your US presence, this guide helps you avoid costly delays and launch with confidence.
As we look back on 2025, we’re grateful for a year defined by innovation, growth, and teamwork at Pure Global. From launching AI-driven regulatory solutions to expanding our global footprint, it was a year of meaningful milestones and shared moments. Thank you to our clients, partners, and incredible team for making it possible—here’s to even greater impact in 2026.
This video explains the AMAR registration framework, device classification scheme, and the critical role of an Israeli Representative (IR). Learn how Pure Global streamlines compliance to help you enter one of the world’s most innovation-driven healthcare systems.
This video explains SFDA’s medical device regulations, the role of an Authorized Representative (AR), and the steps foreign manufacturers must take to gain market access. Learn how Pure Global streamlines compliance and helps you scale across the Middle East.
The Philippines’ medical device market is set to hit USD 1.04 billion by 2029, driven by strong healthcare investment and reliance on imports. This video explains FDA (CDRRHR) rules for device classification, dossiers, labeling, and the critical role of a local representative. Learn how Pure Global accelerates registration and ensures smooth market entry across the Philippines and beyond.
This video explains Mexico’s new Abbreviated Regulatory Pathway, launching September 1, 2025. It enables faster COFEPRIS approvals by recognizing prior authorizations from an expanded list of international regulators. With a 30-business-day target review timeline, this framework reduces redundancy, aligns with global best practices, and accelerates patient access.
This video explains how to register medical devices in Hong Kong under the voluntary MDACS system managed by the MDD. Learn why early registration, especially for higher-risk devices, can give you a competitive edge, and how appointing a Local Responsible Person (LRP) is essential for foreign manufacturers. Pure Global’s expert team ensures compliance and smooth market entry from start to finish.
This video explains how to register medical devices in Thailand under the Thai FDA’s AMDD-aligned regulations, including risk-based classification, licensing requirements, and the mandatory role of a Local Authorized Representative. Learn how to navigate Thailand’s USD $2.29 billion medtech market efficiently and compliantly. Pure Global’s experts in Bangkok streamline your entry into Thailand and the broader ASEAN region.
This video explains how foreign medical device manufacturers can register with the MHRA, achieve UKCA marking, and enter the UK’s $17.67 billion market. Learn why appointing a UK Responsible Person (UKRP) is mandatory, how risk-based classification affects your regulatory pathway, and how expert guidance can accelerate both UK market entry and multi-country expansion.
This video breaks down the MOH’s regulatory framework, device classification (Classes A–D), and the critical role of a Marketing Authorization Holder (MAH) in securing market access. Learn how expert guidance can help you fast-track approvals and tap into one of Southeast Asia’s most dynamic medtech markets.
This video walks you through how to enter Indonesia’s booming medical device market. Learn how NADFC regulations, risk-based classifications, and the requirement for a licensed local representative shape market entry, and what documentation is essential for approval. With the right strategy, Indonesia offers one of Southeast Asia’s biggest growth opportunities for medical device manufacturers.
This video explains how to register medical devices in Malaysia under the MDA’s risk-based system, covering classification, CAB reviews, and the critical role of a Local Authorized Representative. Learn how foreign manufacturers can navigate the process efficiently and meet post-market obligations. Pure Global’s expert team in Kuala Lumpur streamlines MDA registration and opens doors to multiple markets.
This video walks you through the full medical device registration process in Japan, from classification and QMS compliance to appointing a DMAH and submitting your application to PMDA. Learn how to navigate one of the world’s most regulated yet opportunity-rich markets.
This video breaks down the essential steps to achieve CE marking under the EU MDR, from device classification and Notified Body assessment to EUDAMED registration and post-market surveillance. Learn what manufacturers must do to legally market devices in Europe’s $181.6B medtech market. Whether you're self-certifying or preparing for NB review, this is your roadmap to MDR compliance.
This video explains Brazil’s new UDI requirements under ANVISA and the upcoming compliance deadlines that start July 10, 2025 for Class IV devices. Learn how the SIUD database works, what labeling changes are required, and how to prepare your product portfolio for the phased rollout.
Dr. Oliver Eikenberg explains the EU’s new MDCG 2025-5 guidance on IVD performance studies under the IVDR. Learn when submissions to ethics committees and competent authorities are required, how to handle study modifications, and why Good Study Practice is critical for CE marking. These insights help IVD manufacturers and sponsors avoid rejections and stay ahead of regulatory expectations.
This video explains the full process for registering a medical device in Canada with Health Canada, from risk classification and licensing requirements to MDSAP audits and post-market compliance. Learn how to navigate the Canadian Medical Devices Regulations (CMDR) so you can enter one of the world’s fastest-growing medtech markets with confidence. Whether you’re new to Canada or expanding your global presence, this guide shows you the exact steps to secure a Medical Device Licence and stay compliant.
This video walks you through how to register a medical device in Singapore, one of Asia’s fastest-growing medtech markets. Learn about HSA’s four-tier classification system, key dossier and labeling requirements, and why appointing a local Registrant is essential for market entry and compliance. Whether you’re entering Singapore for the first time or expanding across APAC, this guide gives you a clear path to approval.
Expanding into international markets is a massive opportunity for medical device manufacturers, but it comes with significant risks. This video explores how to balance commercial goals with regulatory requirements, from market research and partner selection to post-market vigilance and control over distribution. Learn how an integrated approach turns global expansion into a disciplined, high-impact growth engine.
This video walks you through the full medical device registration process in Colombia with INVIMA, including classification, documentation, and local representation requirements. As one of Latin America’s fastest-growing medtech markets, Colombia offers strong demand, but also strict regulatory expectations. Learn what it takes to enter and succeed in this high-opportunity market.
In this recorded webinar, Dr. Oliver Eikenberg and Eva Camatini, Notified Body - IMQ, break down the most pressing challenges of IVDR compliance for IVD manufacturers. From defining intended purpose to meeting clinical evidence standards and preparing for critical deadlines, this session offers clear, actionable guidance.
This video walks you through the full NMPA registration process for medical devices in China, including classification, dossier preparation, clinical trials, and local representation. With China’s $40B+ medtech market growing rapidly, understanding regulatory expectations is essential for successful entry. Learn how to navigate one of the world’s most complex but high-potential medical device markets.
This video breaks down the full process for registering a medical device in Brazil with ANVISA, including classification, technical documentation, local representation, and post-market surveillance. With Brazil’s healthcare market rapidly expanding and over half of all devices imported, understanding regulatory requirements is key to unlocking growth. Learn what it takes to achieve and maintain compliance in one of Latin America’s most important medtech markets.
This recorded session offers a clear, practical overview of EUDAMED and what manufacturers need to know as the EU moves toward mandatory registration by 2026. Learn how to navigate the system, meet your compliance obligations, and avoid disruptions to EU market access.
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