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This week in medical device regulatory news, Thailand has introduced new refer and transfer guidelines, Europe released an updated Q&A on IVDR and MDR vigilance terms, and Romania has new rules for Economic Operators.

This week, we bring you medical device regulatory update coverage from around the world, including new registration Q&A resources in Taiwan and Japan, UK relaunches ILAP pathway, Mexico will apply a new acquisition model, and more.

This week in medical device regulatory news, EU parliament moves toward a revision of the EU MDR, the UK enhances post-market surveillance requirements, US FDA prioritizes guidance revisions for 2025, and more.

Peru joins IMDRF, updated clinical trial guidance in Denmark, Romania implements new compliance requirements for professionals users, and more in this week's medical device regulatory update.

A necessary evil of a medical device company’s post-market responsibilities.

Ensuring compliance across various jurisdictions can be challenging, but advances in artificial intelligence (AI) are changing the way companies in the medtech sector function.

The co-founder of Pure Global discusses the regulatory consultancy's use of AI to support clients’ marketing submissions and other needs, as well as the AI-enabled medtech landscape and opportunities in China and Southeast Asia for accessing patient data for AI development purposes.

This week in medical device regulatory news: updated guidance on MDR requirements for legacy devices, China released new product guidelines, revised UK guidance on Conditional Marketing Authorizations, and more.

As the MedTech markets expand globally, the need for user-centered design has never been greater. According to the FDA, human factors engineering (HFE) and usability engineering (UE) focus on studying how people interact with technology and how user interface design impacts medical device interactions.

This week in medical device regulatory news: Brazil expedites registration of IVDs for mosquito-born diseases; new US FDA guidance on endosseous dental implants and abutments.

Our first round-up of October 2024 medical device regulatory updates includes new CLSI guidelines and an upcoming webinar in the US, new MDCG guidance documents in Europe, and new industry standards from the NMPA in China.

End of September 2024 brought updates from major markets: EU IVDR transition guidance for Class D IVDs, biocompatibility guidance from the US FDA, IVD family grouping regulations from Brazil, and more.

The Pure Global Resource Center consolidates data from over 30 global markets with local expertise, simplifying global standards to identify the most effective market entry routes.

Medical device regulatory news from the Americas includes enhanced safety and performance standards in Brazil; new device classifications from the US FDA; and a policy for classifying combination products in Canada.

This week, we cover more ANVISA updates from Brazil, including new labeling requirements for certain devices and a clear path for registration transfers, along with new appraisal requirements for high-risk devices in Vietnam.

The platform amalgamates data from over 30 markets, providing various tools to navigate regulatory requirements, monitor medical device registrations, and analyse clinical trials utilising AI-driven insights.

Regulatory authorities have long expected medical device companies to manage the cybersecurity of their products effectively.

September 2024 brings several medical device regulatory developments in Singapore, new ASEAN classification guidance in Malaysia, imminent UDI implementation in Colombia, and more.

The platform consolidates data from over 30 global markets, combining local expertise to simplify global standards and identify optimal market entry routes.

A summary of July and August 2024 medical device and IVD regulatory developments, including insights on the IVDR transition extension, Eudamed and Swissdamed module roll outs, and more.

With minimal regulatory barriers, developers can expedite product development cycles health and wellness apps. However, developers of health products need to be aware that market pressures may eventually lead to initial product designs being classified into new regulatory categories.

Starting August 2024, the Agency will process requests via RIMS, expand consultations for China's med device industry, and launch an NPRA pilot project.

Health Canada updates device standards: new version recognition, 6 new, 12 updated. Temporary inspections start July 1, 2024. Consultation: July 25 - Sep 23, 2024. Stay informed!

In this episode, Medtech Insight senior reporter Hannah Daniel interviews DJ Fang, COO and co-founder of Pure Global. Pure Global employs AI to assist device manufacturers in navigating global regulations. Their discussion covers clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on certain Chinese-made medical devices.

NMPA fosters medical device innovation through regulatory consultations, tailored plans, guidance, updates on approvals, and compliance with MDR, IVDR, and MPDG.

COFEPRIS regulates the transfer of rights to ensure legal and technical compliance for medicines, medical devices, and biological products. Requirements include an application format, proof of payment, legal documentation, and a notice of operation. Transfers must be transparent, with continuous monitoring. Modifications now resolve within 24 hours instead of 3 months.

The Clinical Trials Coordination Group (CTCG) published a Q&A for clinical trial sponsors on safety reporting. Highlights include active RFI monitoring, immutable annual reports, and CTIS transition guidelines.

Recent global regulatory updates include changes for software-based medical devices, prescription lenses, and microbial, recombinant, or animal substances. Effective June 15 and July 1, 2024, with reclassification by July 1, 2026. High-risk devices have limited audits; spectacle lenses are ARTG exempt from June 15.

The two companies are enhancing their ability to navigate regulatory landscapes and effectively facilitate market access.

As regulatory requirements get more complex, the need for speed within the regulatory function becomes increasingly important. Amid these changes, a fundamental question arises: do compliance and regulation have to be so challenging?

In the dynamic landscape of medical device and in vitro diagnostic (IVD) manufacturing, balancing the critical elements of time, resources and regulatory compliance is crucial, reports Phyllis Meng, cofounder and CEO of Pure Global.

In May 2024, major regulatory updates were announced across the UK, EU and Switzerland to enhance medical and in vitro diagnostic devices. The COMBINE project was launched to streamline regulations, and new standards and frameworks were proposed to improve safety, compliance, and timely access to innovative treatments.

In an interview with TechNews180, Pure Global CEO Phyllis Meng discusses how AI and data analytics are revolutionizing market access and regulatory compliance for MedTech companies. Meng highlights Pure Global's platform, which provides seamless access to global registration data and clinical trial information, eliminating manual searches.

Pure Global, a leader in global market access services, and MEDIcept, known for its expertise in US and EU regulatory, quality, and clinical services, have announced their strategic collaboration.

In a significant move to advance the medical device and in vitro diagnostics (IVD) industries, Pure Global and MEDIcept have announced a strategic collaboration designed to streamline global market access and regulatory pathways.

Pure Global, a provider of global market access services, and MEDIcept, a consultancy offering U.S. and EU regulatory, quality, and clinical services, are joining forces to support regulatory compliance and speed market access for medical device and in vitro diagnostics (IVD) providers.

Unlock efficient market access with Pure Global & MEDIcept's collaboration. From registration to regulatory expertise, we offer comprehensive solutions worldwide. Drive growth & innovation in MedTech.

Keep up to date on the most recent developments in the EU regulatory landscape for the medical device sector. Explore our thorough overview of recent updates, encompassing fresh standards, legislative measures, and advisory materials. Delve into the details now to ensure compliance.

Phyllis Meng, CEO of Pure Global, shares her inspirational journey to becoming the founder of Pure Global.

Malaysia, a key gateway to Southeast Asia, offers strategic access for businesses. Understanding medical device regulations is crucial for market entry.

In the dynamic world of MedTech compliance, AI plays a pivotal role. It streamlines regulatory research, enhances data analytics for compliance, and automates tasks, ensuring efficiency and accuracy. Looking ahead, AI-driven digital tools promise even greater efficiency, enabling global collaboration and driving the MedTech industry towards innovation and growth.

Stay updated with the latest EU regulations and guidance in the medical device industry. Check out our comprehensive summary of key updates including new standards, legislative acts, and guidance documents. Dive in now to stay compliant and informed!

Phyllis Meng, CEO of Pure Global, shares insights into their innovative approach to revolutionizing the medical device industry.

Pure Global introduces a new brand and website to boost global outreach and improve client service clarity.

Pure Global COO, DJ Fang, Engages in Key Talks at AstraZeneca's China-Brazil Biomedical Forum to discuss medical innovation.

ANVISA's DICOL Discusses Essential Medical Device Regulations, Enhancing Safety and Regulatory Convergence in Brazil.

Pure Global Secures Two Class II Medical Device Certificates in Brazil, Bolstering International Expansion Capabilities.