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Related websites
Medical Devices Regulations ( SOR /98-282) - Site Web de la
WEBTable of Contents. Medical Devices Regulations. 1 - Interpretation. 2 - Application. 6 - Classification of Medical Devices. 8 - PART 1 - General. 8 - Application. 9 - Manufacturer’s Obligations. 10 - Safety and Effectiveness Requirements.
Laws-lois.justice.gc.caLegislation and Guidelines - Medical devices - Canada.ca
WEBLinks to acts and regulations, guidance documents and policies related to medical devices from Health Canada.
Canada.caMedical devices - Canada.ca
WEBFeb 22, 2023 — Resources related to and required for sale of medical devices in Canada including legislation, Health Canada guidelines, applications and submissions, fees, licences and quality system requirements.
Canada.ca2017/745 - EN - Medical Device Regulation - EUR-Lex
WEBRegulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.
Eur-lex.europa.euFrequently Asked Questions - Medical Devices Regulations
WEBThe Medical Devices Regulations include rules to help classify devices into four risk classes. Class I presents the lowest potential harm; Class IV presents the highest potential harm. Safety and Effectiveness and Labelling Requirements.
Canada.caMedical devices - European Medicines Agency (EMA)
WEBThe Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC. on medical devices and the Directive 90/385/EEC. on active implantable medical devices. The In Vitro Diagnostic Devices Regulation applies since 26 May 2022.
Ema.europa.euRegulations Amending the Medical Devices Regulations (Medical Devices
WEBJan 3, 2024 — Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) Amendments. 1 The heading of Part 1.1 of the Medical Devices Regulations 1 is replaced by the following: Medical Devices for an Urgent Public Health Need. 2 The heading before section 68.01 of the Regulations is replaced by the …
Gazette.gc.caRegulations and standards - Canada
WEBHealth Canada's website has a section for medical device regulations: Acts and Regulations. Guidance Documents. Medical Devices Active Licence Listing (MDALL) Date modified: 2011-11-22. Access information on regulations and learn about quality system requirements in Canada, Europe and the United States.
Ised-isde.canada.caREGULATION (EU) 2017/ 745 OF THE EUROPEAN …
WEBMay 6, 2017 — Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst suppor ting innovation.
Eur-lex.europa.euMedical Device Regulation comes into application
WEBMay 26, 2021 — The medical device regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products.
Ema.europa.eu