Swiss Medical Device Ordinance

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New regulations applicable to medical devices as of 26 …

https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/neue-regulierug-mep-26-05-2021.html

These enter into force on 26 May 2021, at the same time as the completely revised Medical Devices Ordinance (MedDO) and a new Ordinance on Clinical Trials with Medical Devices (CTO-MedD). In the context of aligning Swiss medical devices …

812.213 Medical Devices Ordinance - admin.ch

https://fedlex.data.admin.ch/filestore/fedlex.data.admin.ch/eli/cc/2001/520/20200801/en/pdf-a/fedlex-data-admin-ch-eli-cc-2001-520-20200801-en-pdf-a.pdf

Medical Devices Ordinance 3 812.213 2 They must be manufactured on written prescription and under the responsibility of a duly qualified professional. 3 The …

812.213 - Medical Devices Ordinance of 17 October 2001 (MedDO)

https://lex.weblaw.ch/lex.php?norm_id=812.213&source=sr&lex_id=7188&use_lang=en

1 Medical devices are instruments, apparatus, appliances, software, materials, accessories or other medical technology articles, whether used alone or in …

(MedDO) - Weblaw AG

https://lex.weblaw.ch/lex.php?norm_id=812.213&source=SR&lex_id=7184&file=en-pdf_file_a.pdf

Medical Devices Ordinance 3 812.213 Section 2 Definitions and References to European Legislation Art. 3 Medical device and accessories 1 Medical devices are instruments, …

(MedDO) - admin.ch

https://fedlex.data.admin.ch/filestore/fedlex.data.admin.ch/eli/cc/2001/520/20150415/en/pdf-a/fedlex-data-admin-ch-eli-cc-2001-520-20150415-en-pdf-a.pdf

Medical devices are instruments, apparatus, appliances, software, materials, acces-sories or other medical technology articles, whether used alone or in combination, including the …

Regulation | Swiss Medtech

https://www.swiss-medtech.ch/en/regulation

Medical Device Regulation in Switzerland. Switzerland has had a national medical device regulation since 1996. The partial revision of the Law on Therapeutic …

Regulation of medical devices - Swissmedic

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices.html

Basic information on medical devices. Unlike medicinal products, medical devices do not undergo an official authorisation procedure. For these devices, Switzerland …

Placing Medical Devices on the Swiss Market After the EU MDR …

https://www.emergobyul.com/news/placing-medical-devices-swiss-market-after-eu-mdr-date-application

However, from the Date of Application of the EU Medical Devices Regulation (MDR) on May 26, 2021, this is no longer the case; Switzerland will become a …

Switzerland approves MedDO revision and …

https://www.emergobyul.com/news/switzerland-approves-meddo-revision-and-moves-toward-mdr-harmonization

The Swiss Federal Council has approved a thorough revision of the Medical Devices Ordinance ( MedDO ), along with the new Ordinance on Clinical Trials …

Swiss medical device regulations, medical device ordinance, CH …

https://www.ch-repservices.com/swissmedic-mandate

The EEA and the EU-based countries have various grace periods for different risk classes of the devices till July 31, 2022. Under IVDO. Foreign manufacturers other …

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