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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, Australia, China, etc.), so that you can know and update the laws and regulations involved in a timely manner.
This week's (0714-0721) regulatory updates are as follows:
法规更新清单表（0714-0721） | ||||
Number | Country | Release Date | Title | Link |
1 | European Union | 2023.07.18 | Rev. 1 - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 | https://health.ec.europa.eu/latest-updates/rev-1-qa-practical-aspects-related-implementation-regulation-eu-2023607-2023-07-18_en |
2 | European Union | 2023.07.17 | Updated - Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices | https://health.ec.europa.eu/latest-updates/updated-factsheet-authorities-non-eueea-states-medical-devices-and-vitro-diagnostic-medical-devices-2023-07-17_en |
3 | America | 2023.07.17 | Qualification of Medical Device Development Tools | https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-medical-device-development-tools |
4 | Britain | 2023.07.17 | Updated - Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices | https://health.ec.europa.eu/latest-updates/updated-factsheet-authorities-non-eueea-states-medical-devices-and-vitro-diagnostic-medical-devices-2023-07-17_en |
5 | Britain | 2023.07.18 | MHRA launches public consultation on reclassification of opioid-containing cough medicine | https://www.gov.uk/government/news/mhra-launches-public-consultation-on-reclassification-of-opioid-containing-cough-medicine |
6 | South Korea | 2023.07.20 | Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices | https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=72627&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1 |
7 | South Korea | 2023.07.20 | Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices | https://www.mfds.go.kr/eng/brd/m_40/view.do?seq=72628&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1 |
8 | China | 2023.07.18 | Guidelines for Registration Review of Continuous Glucose Monitoring Systems (Revised 2023) (No. 24 of 2023) | https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230719144356135.html |
9 | China | 2023.07.18 | Guidelines for Registration and Review of Transcatheter Aortic Valve Systems (No.25 in 2023) | https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230719144712199.html |
10 | China | 2023.07.20 | Guiding Principles for Registration and Review of Extracorporeal Membrane Pulmonary Oxygenation (ECMO) Temperature Control Equipment (No. 26, 2023) | https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230720100050146.html |
11 | China | 2023.07.18 | Guiding Principles for Registration and Review of Vascular Interventional Devices with Lubricating Coatings (No. 25 of 2023) | https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230719144807150.html |
12 | China | 2023.07.18 | Guiding Principles for Registration and Review of Non vascular Self expanding Metal Stent Systems (No. 25 of 2023) | https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230719144929157.html |
13 | China | 2023.07.20 | Guiding Principles for Registration and Review of Mobile ECG Atrial Fibrillation Detection Products (No. 26, 2023) | https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230720100122167.html |
14 | China | 2023.07.20 | Guiding Principles for Registration and Review of High Flow Respiratory Therapy Equipment (No. 26 of 2023) | https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230720100222117.html |
15 | China | 2023.07.20 | Guiding Principles for Registration and Review of Insulin pump (No.26 in 2023) | https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230720100152131.html |
16 | China | 2023.07.18 | Technical Guidelines for Benefit-Risk Determination of Medical Device Products (Revised 2023) (No. 25 of 2023) | https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20230719145028159.html |
17 | China | 2023.07.19 | Opinions of the State Food and Drug Administration on Further Strengthening and Improving the Classification Management of Medical Devices | https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20230719162218145.html |
Note: The above list is only for sharing purposes and is not exhaustive, and there may be omissions.
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