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This week in medical device regulatory news, the European Commission has updated official guidance on the classification of IVDs under the IVDR; Brazil has opened public consultation on UDI database management and suspended electronic signature requirements; and China revised its regulations on domestic production of imported medical devices.

In this week's regulatory update, we bring you news from Brazil and China, including new guidelines for medical device clinical trial inspections from China's NMPA and the availability of medical device price monitoring data on ANVISA's Business Intelligence dashboards.

This week's round up of medical device regulatory news covers digital advancements, including the official publication of the Regulation on the European Health Data Space (EHDS) in the EU and the introduction of Avisalegis, a subscription-based notification service that alerts users about new regulatory publications in Brazil.

This week in global medical device news: Brazil's ANVISA goes 100% digital, more Approved Bodies in the UK, revised guidance on HIV self-test kits in Malaysia, and more.

The fifth revision to the EU's guidance on Notified Body requirements under the MDR and IVDR has been released. Canada published new guidance on machine learning-enabled devices, findings from China's Medical Device Standards Management Annual Report, and more in this week's round-up of medical device regulatory news.

To close out January 2025, we are reporting on medical device regulatory developments in the European Union and Switzerland, including IVDR compliance challenges cited in the MedTech Europe 2024 Regulatory Survey, as well as guidance, FAQ, and form updates from Swissmedic.

Wrapping up January 2025, medical device regulatory developments include new forms for NBs in Europe, new PMS guidance in the UK, an expedited approval partnership between China and Malaysia, and warnings of supply chain disruptions for pediatric patients in the US.

Medical device regulatory developments from the US and Thailand include: final FDA guidance on modular review for premarket approval applications and humanitarian device exemptions, and new expedited regulatory routes for low-risk devices and chronic disease prevention devices in Thailand.

This week, we are reporting on medical device regulatory updates from Canada, Europe, Brazil, and China. China's NMPA released registration review timelines, clarification on MDR and IVDR vigilance terms is now available, and Health Canada updated validation rules for non-eCTD transactions.

To kick off 2025, we bring you a round up of medical device regulatory updates from across Europe and the US, including a new position paper from TEAM-NB on MDR certification processes and numerous guidance updates from the US FDA.

Closing out 2024, we bring you substantial medical device updates from Europe, Brazil, and beyond, including the launch of public consultation on EU device regulations, an updated roadmap for regulatory implementations in the UK, and several new and updated resolutions in Brazil.

Early December 2024 regulatory news brings updates from Europe, US, Brazil, China, and Japan, including new FDA guidance on change controls for AI-enabled devices and an innovation-focused approach to clinical research regulations in Brazil.

An extensive round-up of medical device regulatory news from November 2024 includes new and updated guidance documents, Q&As, and directives from Europe and the US, including the new EU Product Liability Directive for AI and Smart Products.

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.

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.

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.

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.

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

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.

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.

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.

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.

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!

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

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