LFH Regulatory Limited’s Post

🌟 Catch my video below reflecting on the last 3 days at MEDICA - Leading International Trade Fair ! 🌟 From navigating new regulatory changes to answering specific compliance queries, our team is here to address the regulation questions we’re hearing most frequently at the UK Pavilion. If you’re at MEDICA and need guidance on regulatory requirements, stop by our stand – we’d love to discuss how we can support your pathway to market success! #MEDICA2024 #RegulatorySupport #MedicalDevices #Compliance #UKPavilion

After the 2024 HFES - Human Factors and Ergonomics Society conference, Julee Harlow Henry and I fielded lots of questions about China NMPA’s latest guidance released last Thursday. Join some other members our team for a deeper dive into the latest and greatest!

🚨 New MHRA Policy Alert! 🚨 On May 21, 2024, the MHRA announced a groundbreaking policy for the UK market, recognizing international regulatory approvals for medical devices. 🌍 This move aims to streamline the approval process, reduce regulatory burdens, and focus on high-risk and innovative products. Key Points: ➡️ Recognition of approvals from Australia, Canada, EU, and USA. ➡️ Reduced duplication for manufacturers. ➡️ Focus on high-risk and novel devices. Read the full NAMSA details here: https://lnkd.in/ggiQ-_4p #MedicalDevices #NAMSAKnows #RegulatoryAffairs #MHRA #HealthcareInnovation

In case you have not heard, Emergo by UL reports on the UK MHRA announcement (21 May) about global harmonization. The MHRA has released their proposed policy to leverage regulatory authorizations, as they have titled “international recognition of medical devices”. Read our Regulatory Update (with our Program Manager Karen Hill) for a synopsis, and an understanding of the following: Comparable Regulator Countries (CRCs), how indefinite CRC authorizations would be time limited, basis for UK classification, and the access routes: https://lnkd.in/gJP7awJG . Image of first page of the UK MHRA draft policy document. Article two will discuss the access routes in greater detail as well as the timing of this initiative. Cheers for global harmonization! Regulatory reliance as discussed at the IMDRF 25th Annual Meeting, here we come! #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #UK #MHRA #regulatoryreliance #globalharmonization #IMDRF #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

Meet our experts at Hospitalar in Brazil on May 21-24. (booth: H-169) Do not miss this good opportunity to discuss with our team about complex regulatory challenges. #weareulsolutions #EmergobyUL #Hospitalar2024 #medicaldevice #Brazil #regulatory

Established after #Brexit, the UK Responsible Person Association (#UKRPA) was created to represent and promote professionals working as a #UK #ResponsiblePerson (#UKRP) in the medical technologies (#medtech) sector. This article from Mika Reinikainen in the #June 2024 issue of #RegulatoryRapporteur discusses the evolving role of the #UKRP and the future requirements such as post-market surveillance. Read #RegulatoryRapporteur online now 👉 https://lnkd.in/ep9mCpXr #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This edition focuses on access to #medicines and looks at how #regulators, #HTA bodies and other organisations are facilitating #patients access to #medicines through creation and participation in intricate global networks. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join

Nine European countries presented a top-line #MDR/IVDR reform proposal to the EU Council that would give more centralized device authority to the European Medicines Agency and seek to remove some “administrative obligations” for companies. The proposal comes at the start of a new term of the European Commission that includes a remit to consider legislative changes to the device regulations: https://bit.ly/4ionP0J #medtech

#ICYMI: Nine European countries presented a top-line #MDR/IVDR reform proposal to the EU Council that would give more centralized device authority to the European Medicines Agency and seek to remove some “administrative obligations” for companies. The proposal comes at the start of a new term of the European Commission that includes a remit to consider legislative changes to the device regulations: https://bit.ly/4ionP0J #medtech

New RDC 848/2024: What changes in safety and performance evaluation of medical devices in Brazil from September 2024?

In September 2024, Collegiate Board Resolution (RDC) No. 848 will come into force, imposing strict new guidelines on the safety and performance evaluation of medical devices in Brazil. These regulations, in line with international standards such as ISO 14971 and ISO 10993, reinforce the importance of comprehensive testing and detailed documentation to ensure that medical devices are safe for clinical use.      The new RDC aims to ensure that medical devices do not pose undue risks to patients, healthcare professionals or third parties, and that they perform as expected under real clinical conditions. The process involves risk analyses, tests for compliance with safety standards and biocompatibility studies, as well as functional and clinical validations.      To find out more about how this new regulation will impact the departament and the steps needed to ensure the compliance of medical devices, read the full article on our blog. Be sure to check it out and keep up to date with best practices and regulatory requirements for medical devices.      Access link:  https://lnkd.in/dMHPPENV     #ANVISA #RDC848