EU MDR Transition web publication service From Therapeutic Goods Administration (TGA) 🇦🇺 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
Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for industry and FDA staff on predetermined change control plans for medical devices in the premarket phase. 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 1 month ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) 🇺🇸 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. Regulation. Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices From European Medicines Agency (EMA) 🇪🇺 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) 🇦🇺 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
Guiding principles: Predetermined change control plans for machine learning-enabled medical devices From Health Canada 🇨🇦 FDA, Health Canada and MHRA jointly identified 5 guiding principles for predetermined change control plans, drawing upon GMLP guiding principles, particularly stating that deployed models are monitored for performance and re-training risks are managed. 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 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Medical Devices Compliance Program Bulletin From Health Canada 🇨🇦 Information on regulatory activities, process changes and hot issues regarding medical device establishment licencing. 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 26, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Updates to the list of recognized standards for medical devices and draft guidance: Notice From Health Canada 🇨🇦 Notice on Health Canada's proposed changes to the guidance on recognized standards for 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 July 25, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Share your views: Updates made to list of recognized standards for medical devices and draft guidance From Health Canada 🇨🇦 Health Canada invites you to comment on proposed changes to the guidance on the list of recognized standards for 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 July 25, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Vapes: information for wholesale, transport, logistics and storage facilities From Therapeutic Goods Administration (TGA) 🇦🇺 Learn what the regulatory changes mean for the supply and commercial possession of therapeutic vapes. 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Vapes: information for sponsors, importers and manufacturers From Therapeutic Goods Administration (TGA) 🇦🇺 Learn what the regulatory changes mean for the importation and manufacture of therapeutic vapes. 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Changes to the regulation of vapes From Therapeutic Goods Administration (TGA) 🇦🇺 Find out about changes to the regulation of all vapes in Australia. 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Vapes: information for prescribers From Therapeutic Goods Administration (TGA) 🇦🇺 Learn what the regulatory changes mean for prescribing therapeutic vapes for patients for smoking cessation or the management of nicotine dependence. 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Vapes: information for pharmacists From Therapeutic Goods Administration (TGA) 🇦🇺 Learn about changes to the regulation of vapes, what the changes mean for sourcing these products and the requirements for dispensing. 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guide to Fees for Human Products From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document outlining fees associated with human products. 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 July 3, 2024 Other (Public Domain) 0 reuses 0 favorites
Regulatory changes for software based medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device). 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 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems From Therapeutic Goods Administration (TGA) 🇦🇺 Publication of submissions to the public consultation paper Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed changes to the classification of active implantable medical devices and their accessories From Therapeutic Goods Administration (TGA) 🇦🇺 Publication of submissions to the public consultation paper Proposed changes to the classification of active implantable medical devices and their accessories 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA thanks respondents who provided a submission in response to the public consultation paper 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 June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ZL201_00_001e_WL Guidance document Renewal and discontinuation of authorisation or change of status (main authorisation/export licence) From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Guidance document on renewing, discontinuing, or changing the status of authorizations or export licenses. 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 June 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites