Betty Xu’s Post

On May 11, 2024, China’s National Medical Products Administration (NMPA) released the Announcement on Rules for the Classification of Medical Device Products (hereinafter referred to as the Rules). The enforcement of the Rules will start from September 1, 2024. Background The Rules will replace the current version of the working procedures and requirements for the classification of medical devices,   stipulated in Document No. 127 of 2017. In recent years, the medical device industry has developed rapidly, which presented new challenges for classifying and managing medical devices, such as for responding to the public emergency incidents. The need to further optimize the process, requirements, and efficiency of classification work has become urgent. Therefore, the NMPA organized the revision of the Rules, also aimed at supporting some of the tasks assigned in the Opinions of the National Medical Products Administration on Further Strengthening and Improving the Classification Management of Medical Devices, namely, enhancing the quality and efficiency of classification determination work, and promoting the innovative development of medical devices. The Rules encompass three parts: https://lnkd.in/gggZqxNs

On May 11, 2024, China’s National Medical Products Administration (NMPA) released the Announcement on Rules for the Classification of Medical Device Products (hereinafter referred to as the Rules). The enforcement of the Rules will start from September 1, 2024. Background The Rules will replace the current version of the working procedures and requirements for the classification of medical devices,   stipulated in Document No. 127 of 2017. In recent years, the medical device industry has developed rapidly, which presented new challenges for classifying and managing medical devices, such as for responding to the public emergency incidents. The need to further optimize the process, requirements, and efficiency of classification work has become urgent. Therefore, the NMPA organized the revision of the Rules, also aimed at supporting some of the tasks assigned in the Opinions of the National Medical Products Administration on Further Strengthening and Improving the Classification Management of Medical Devices, namely, enhancing the quality and efficiency of classification determination work, and promoting the innovative development of medical devices. https://lnkd.in/gggZqxNs

On May 11, 2024, China’s National Medical Products Administration (NMPA) released the Announcement on Rules for the Classification of Medical Device Products (hereinafter referred to as the Rules). The enforcement of the Rules will start from September 1, 2024. Background The Rules will replace the current version of the working procedures and requirements for the classification of medical devices,   stipulated in Document No. 127 of 2017. In recent years, the medical device industry has developed rapidly, which presented new challenges for classifying and managing medical devices, such as for responding to the public emergency incidents. The need to further optimize the process, requirements, and efficiency of classification work has become urgent. Therefore, the NMPA organized the revision of the Rules, also aimed at supporting some of the tasks assigned in the Opinions of the National Medical Products Administration on Further Strengthening and Improving the Classification Management of Medical Devices, namely, enhancing the quality and efficiency of classification determination work, and promoting the innovative development of medical devices. https://lnkd.in/gggZqxNs

Medical devices: Council adopts new measures to help prevent shortages The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation adopted today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: further extending the transition period for certain IVDs enabling a gradual roll-out of EUDAMED, the new electronic database requiring manufacturers to flag up potential shortages of critical medical devices and IVDs Overview of the key changes In 2017, new rules were introduced to modernise and update the EU framework for IVDs, guaranteeing their safety and effectiveness. The amendment adopted today extends the deadline for transitioning to the new system under certain conditions, to avoid shortages of critical IVDs without compromising on safety. The new regulation also enables a gradual roll-out of the European database on medical devices (EUDAMED) by requiring manufacturers to provide information about their products to existing EUDAMED modules without needing to wait for the remaining modules to be completed. This mandatory registration is expected to take effect as of late 2025. Today’s revision also introduces an obligation for manufacturers to give prior notice about any interruption of supply of certain critical medical devices or IVDs to relevant authorities, health institutions, healthcare professionals and economic operators to whom they supply the device. https://lnkd.in/d6vuMSzC

30May24 :Medical devices: Council adopts new measures to help prevent shortages "The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation adopted today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: - further extending the transition period for certain IVDs - enabling a gradual roll-out of EUDAMED, the new electronic database - requiring manufacturers to flag up potential shortages of critical medical devices and IVDs In 2017, new rules were introduced to modernise and update the EU framework for IVDs, guaranteeing their safety and effectiveness. The amendment adopted today extends the deadline for transitioning to the new system under certain conditions, to avoid shortages of critical IVDs without compromising on safety. The new regulation also enables a gradual roll-out of the European database on medical devices (EUDAMED) by requiring manufacturers to provide information about their products to existing EUDAMED modules without needing to wait for the remaining modules to be completed. This mandatory registration is expected to take effect as of late 2025." #EUMDR #Medicaldevice https://lnkd.in/egjP_ii6

What are the common specifications for medical devices’ intended purpose? What are the technical and clinical evaluation requirements? Learn more about these requirements from our latest blog. https://lnkd.in/dikBRQf3 #MedicalDevices #CommonSpecifications #TechnicalRequirements #ClinicalEvaluation #RegulatoryAffairs #FryerSolutions #Blogs

Join us to learn more about the TGA Medical Devices Reforms. This second webinar will be focus on regulatory framework for personalised medical devices (PMD). 

📢 Announcement from TS Quality & Engineering: Introducing swissdamed – the Swiss Database for Medical Devices 🌐📊 We’re thrilled to announce that the first module of the swissdamed medical devices database is now live! 🎉 What is swissdamed? swissdamed is the brand-new Swissmedic database designed for registering economic operators and medical devices, including in vitro diagnostic medical devices, within the Swiss market. Check here: https://lnkd.in/dQK6UdCs Key Features: Transparency Boost: Starting from August 6, 2024, swissdamed will provide crucial information about medical devices available in Switzerland, along with the responsible economic operators. This transparency initiative aims to enhance safety and accountability. Two Modules: The database comprises two modules: “Actors” and “Devices.” Phased Roll-Out: They’re launching swissdamed in phases, with ongoing optimizations to ensure a seamless experience. Upcoming Milestones: August 6, 2024: Register your economic operators. 2025: Voluntary registration of “Regulation Devices” (MDR and IVDR) using XML files in the EUDAMED format. 🔍 Stay informed! Don’t miss any updates on swissdamed by visiting our website: swissdamed updates 👥 Let’s collaborate to create a safe and transparent medical devices data environment in Switzerland! 🙌 #healthcare #medicaldevices #transparency #Swissmedic #swissdamed

Another medical device settlement announced by the Dept of Justice – this one with Ra Medical over its DABRA laser for artery disease (Ra Medical is now merged into Catheter Precision and had already settled some aspects of the below allegations a few years ago).   Core allegations that are good reminders on areas of continued government scrutiny:   1. Marketing devices for unapproved uses: Ra Medical marketed its DABRA Laser for use in atherectomies, a procedure where plaque is mechanically removed from occluded blood vessels in patients suffering from peripheral artery disease. The FDA had not approved the DABRA Laser for use in atherectomy procedures.   2. Marketing despite knowing about performance issues: Ra Medical marketed the DABRA Laser despite product performance issues causing frequent calibration and overheating problems, which posed a risk to physicians and patients, and prompted a recall in August 2019.   3. Providing Kickbacks: Ra Medical paid physicians to induce them to use the DABRA Laser in violation of the Anti-Kickback Statute. The payments allegedly consisted of cash and fees paid in connection with purported training events and consulting services. The government alleged that Ra Medical tracked utilization of its high-volume physician customers using an internal document titled “Who Deserve[] Love,” which was used to identify physicians that RMS should target with offers of improper remuneration. Two of the recipients of the alleged kickbacks also settled with the government as part of this investigation. 

The Medical Device Coordination Group #MDCG has endorsed the new revision to MDCG 2021-5, Guidance on standardisation for medical devices. Among the changes to the #guidance are updates on 'state of the art': -  it is commonly considered that the most recent versions of standards with the technical solutions they contain reflect the “state of the art” - compliance with the most recent version of a standard the reference of which has not been published in the OJEU does not automatically imply compliance with the requirements of the applicable EU legislation When using #SOTA concepts with your device, you must remember that "state-of-the-art” standards as such do not confer any presumption of conformity if their references are not cited in the OJEU. https://lnkd.in/eZF4eFkc #standards #standardization #standardisation #medicaldevices #NSB #IVD