Medical Devices Regulations - SOR/98-282 From Department of Justice Canada π¨π¦ Federal laws of Canada Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 week ago Open Government License 2.0 (Canada) 0 reuses 0 favorites
Fees In Respect of Medical Devices Regulations - SOR/98-432 From Department of Justice Canada π¨π¦ Federal laws of canada Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 week ago Open Government License 2.0 (Canada) 0 reuses 0 favorites
Fees in Respect of Drugs and Medical Devices Regulations - SOR/2011-79 From Department of Justice Canada π¨π¦ Federal laws of canada Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 week ago Open Government License 2.0 (Canada) 0 reuses 0 favorites
EU MDR Transition web publication service From Therapeutic Goods Administration (TGA) π¦πΊ The EU MDR Transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Medical devices From European Medicines Agency (EMA) πͺπΊ Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
How we are managing medical device supply disruptions resulting from changes in Europe From Therapeutic Goods Administration (TGA) π¦πΊ We are managing the impact of the European Union Medical Devices Regulation (EU MDR) transition in Australia. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices overview From Therapeutic Goods Administration (TGA) π¦πΊ Overview of medical devices regulation Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices: UK approved bodies From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 2, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the βsell offβ periods From European Commission πͺπΊ Q&A on implementing EU Regulation 2023/607, covering MDR transitional period extension and removal of "sell off" periods. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 10, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
MDR/IVDR forms From National Institute of Pharmacy and Nutrition (OGYΓI) ππΊ A document containing forms related to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 24, 2024 Other (Public Domain) 0 reuses 0 favorites
Online assessment tool and online notification form From Therapeutic Goods Administration (TGA) π¦πΊ Use our online assessment tool and notification form to transition to the new EU MDR, so you can continue supplying medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
EU MDR Transition From Therapeutic Goods Administration (TGA) π¦πΊ Overview and management of the EU European Union Medical Devices Regulation (MDR) transition under the Australian regulatory framework. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Common specification requirements for in vitro diagnostic devices From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 21, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical devices: new guidance for industry and notified bodies From European Medicines Agency (EMA) πͺπΊ A document providing updated guidance for the medical device industry and notified bodies. Metadata quality: Metadata quality: Data description empty Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices regulations: compliance and enforcement From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Information on MHRA's enforcement duties and how to report a non-compliant medical device. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 17, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Preliminary re-assessment review (PRAR) form template (MDR) From European Commission πͺπΊ A template for the Preliminary Re-assessment review (PRAR) form under the MDR. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 16, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Preliminary assessment review (PAR) form template (MDR) From European Commission πͺπΊ A template for Preliminary Assessment Review (PAR) form under the MDR. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 16, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD From European Commission πͺπΊ Guidance on surveillance for devices covered by MDD or AIMDD certificates under Article 120 of the MDR. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 27, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations From Health Canada π¨π¦ 2006 Health Canada guidance document providing guidance for medical devices manufacturers on the use of standards in demonstrating compliance with the Safety and Effectiveness Requirements and Labelling Requirements of the Canadian Medical Devices Regulations Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 15, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Medical Devices; Technical Amendments From Food and Drug Administration (FDA) πΊπΈ Document number 2024-05473. The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to update a citation for information collection and conform the regulatory provisions to the Federal Food, Drug, and Cosmetics Act (FD&C Act). The rule does notβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 15, 2024 Other (Public Domain) 0 reuses 0 favorites