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AMDR comments to the Spanish Royal Decree …
- https://amdr.org/2021/07/amdr-comments-to-the-spanish-royal-decree-regulating-medical-devices/
- First Global Regulatory Standards for “Single-Use” Medical Device Reprocessing and Remanufacturing Published by the Association of Medical Device Reprocessors June 6th, 2022 U.S. …
Spain: New project for royal decree regulating …
- https://www.globalcompliancenews.com/2021/07/06/spain-new-project-for-royal-decree-regulating-medical-devices21062021/
- The Spanish Ministry of Health is working on a project for a new royal decree regulating medical devices following the adoption of a new framework at the European level through Regulation (EU) …
KSA update: New Saudi medical device regulation, GHTF
- https://www.emergobyul.com/news/ksa-update-new-saudi-medical-device-regulation-ghtf-applications-ai-requirements-and-more
- A royal decree of the Kingdom of Saudi Arabia (KSA) established a new medical device regulation, to take effect later this year. The Saudi Food and Drug …
MDS-REQ 3 Requirements for Safe Use of Medical …
- https://www.sfda.gov.sa/sites/default/files/2022-03/MDS-REQ3E.pdf
- a) Maintenance of medical device, including periodic preventive maintenance (PPM), corrective maintenance, calibration and quality assurance tests. b) Reprocessing …
Draft text of new Spanish regulation on medical devices …
- https://www.engage.hoganlovells.com/knowledgeservices/news/draft-text-of-new-spanish-regulation-on-medical-devices-is-opened-for-contributions
- The draft text will be available for contributions by 10 July 2021. The direct application of Regulation (EU) 2017/745 of the European Parliament and of the Council of …
Draft text of new Spanish regulation on medical devices …
- https://www.jdsupra.com/legalnews/draft-text-of-new-spanish-regulation-on-9596858/
- In this respect, the new regulation aims to: (i) repeal the existing legal texts on medical devices (Royal Decree 1591/2009) and active implantable medical devices …
Legislation | FAMHP
- https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/legislation
- The Act dated 15 December 2013 – concerning medical devices. The Royal Decree dated 15 November 2017 – Royal Decree concerning the notification of a contact …
Pharmaceutical & medical device advertising regulation …
- https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/spain
- In general terms, the failure to comply with the relevant rules applicable to the advertising of medicines and medical devices may entail administrative infringements punishable with …
Royal Decree Medical Devices | Day of Difference
- https://dayofdifference.org.au/r-medical/royal-decree-medical-devices.html
- The Royal Decree forms part of a package of measures for the implementation of Regulation (EU) 2017/745 on medical devices, also known as the Medical Device …
New Belgian legislation on the distribution of medical …
- https://www.engage.hoganlovells.com/knowledgeservices/news/new-belgian-legislation-on-the-distribution-of-medical-devices
- The Royal Decree forms part of a package of measures for the implementation of Regulation (EU) 2017/745 on medical devices, also known as the …
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