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Regulations are a topic that keeps up with the times. As both enterprises and registrants, they need to have a keen ability to identify regulations to ensure that the latest regulations can be adopted in a timely and effective manner, and to avoid related issues in the conformity assessment process. It can be seen how important it is to have a comprehensive and timely communication of regulatory updates.
The Guorui Zhong'an Group IVDAER team will regularly summarize the update of laws and regulations in Relevant market and regulatory websites (such as the EU, the United States, Australia, the United Kingdom, China, etc.), so that you can know and update the laws and regulations involved in a timely manner.
This week's (0721-0728) regulatory updates are as follows:
List of Regulatory Updates (0721-0728) | ||||
Number | Country | Release Date | Title | Link |
1 | European Union | 2023.07.24 | EUHPP Live Webinar: Meeting on EU Reference Laboratories (EURLs) for public health - Stakeholder Webinar (29 August 2023, 15.00 - 16.30 CEST) | https://health.ec.europa.eu/latest-updates/euhpp-live-webinar-meeting-eu-reference-laboratories-eurls-public-health-stakeholder-webinar-29-2023-07-24_en |
2 | Britain | 2023.07.27 | Submitting an application for review by the ACBS | https://www.gov.uk/government/publications/how-to-submit-an-application-for-acbs-approval |
3 | America | 2023.07.24 | Sterilization for Medical Devices | https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices |
4 | European Union | 2023.07.25 | Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 31 March 2023) | https://health.ec.europa.eu/latest-updates/updated-document-notified-bodies-survey-certifications-and-applications-mdrivdr-survey-results-data-2023-07-25_en |
5 | European Union | 2023.07.26 | Advice on the influenza virus on request from the Medical Device Coordination Group | https://health.ec.europa.eu/latest-updates/advice-influenza-virus-request-medical-device-coordination-group-2023-07-26_en |
6 | America | 2023.07.26 | Hydrogen Peroxide Solution | https://www.fda.gov/medical-devices/contact-lenses/hydrogen-peroxide-solution |
7 | Australia | 2023.07.25 | Vaping products, medicinal cannabis and the wellness industry included in 2023-24 compliance and enforcement priorities | https://www.tga.gov.au/news/news/vaping-products-medicinal-cannabis-and-wellness-industry-included-2023-24-compliance-and-enforcement-priorities |
8 | Britain | 2023.07.26 | Software and Artificial Intelligence (AI) as a Medical Device | https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device |
9 | Britain | 2023.07.27 | Implementation of medical devices future regime-Implementation of the Future Regulations | https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations |
10 | China | 2023.07.24 | Letter from the Comprehensive Department of the National Drug Administration on Agreeing to Establish a Centralized Unit for Standardization Technology of Medical Device Packaging | https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20230724162910119.html |
11 | China | 2023.07.24 | Notice of the Equipment Review Center of the National Drug Administration on Issuing the Guiding Principles for Clinical Evaluation, Registration and Review of Hip Joint Prostheses of the Same Variety (No. 27 of 2023) | https://www.cmde.org.cn/xwdt/shpgzgg/gztg/20230724140030180.html |
12 | China | 2023.07.24 | Notice of the National Drug Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation (No. 33 of 2023) | https://www.cmde.org.cn/flfg/fgwj/tz/20230725085258194.html |
13 | China | 2023.07.28 | The structural composition of the registered product includes the host and accessories (consumables). The host has been discontinued. Can I apply for a change in registration to delete the host and only retain the attachments to meet the compatibility needs of the existing host | https://www.cmde.org.cn/splt/ltgxwt/20230728104033158.html |
14 | China | 2023.07.28 | How to choose extraction solvents in the study of extraction performance of contact lens products | https://www.cmde.org.cn/splt/ltgxwt/20230728104125148.html |
Note: The above list is only for sharing purposes and is not exhaustive, and there may be omissions.
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