Regulatory obligation for exempt medical devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Exempt therapeutic goods do not need to be included in the ARTG. They do still need to comply with other regulatory requirements. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 in vitro diagnostics - Guidance on ongoing requirements for sponsors and manufacturers From Therapeutic Goods Administration (TGA) ๐ฆ๐บ A guide for sponsors of COVID-19 IVDs about their ongoing obligations 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Digital tools and medical devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ This guidance helps providers of digital mental health services or products to understand their regulatory obligations and outlines the key differences between regulation and oversight by the TGA for digital mental health tools and products. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Registration of in vitro diagnostic medical devices in the national database From Ministry of Health (Italy) (MDS) ๐ฎ๐น Waiting for the fully functionality of European Database Eudamed , at the moment in Italy the obligations provided for in Article 10 of Legislative Decree 332/2000 shall continue to apply, untill twenty-four months after the date of the publication of the notice on the functionality of Eudamed. 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 14, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Medical device labelling obligations From Therapeutic Goods Administration (TGA) ๐ฆ๐บ This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations. 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 February 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices From European Parliament ๐ช๐บ This document is a proposal to amend regulations regarding the roll-out of Eudamed, supply interruptions, and transitional provisions 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 January 23, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Swiss authorised representative (CH-REP) From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Learn about the Swiss authorised representative (CH-REP) and how it facilitates market access. 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 November 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Obligations for authorised representatives, importers and distributors From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Learn about the obligations for authorised representatives, importers, and distributors in relation to market access. 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 November 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Reporting system for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) ๐ฎ๐น The Ministry of Health carries out the activities of monitoring and investigating reports from healthcare professionals and manufacturers. On Sept. 28, 2022, Legislative Decree No. 138 of Aug. 5, 2022 , came into force, which in Article 13 provides fulfillments for manufacturers of in vitroโฆ 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, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Obligations of manufacturers of custom-made devices according to the MDR From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ This document outlines the responsibilities of manufacturers of custom-made devices in compliance with the Medical Device Regulation (MDR). 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Therapeutic goods advertising and ASX announcements From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Complying with the advertising rules for therapeutic goods while meeting continuous disclosure obligations. 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 3, 2023 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 821 Medical Device Tracking Requirements From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "Medical Device Tracking Requirements" under 21 CFR Chapter I Subchapter H. 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 March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Crafting an intended purpose in the context of Software as a Medical Device (SaMD) From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations. 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 22, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
FAQ Regulation MD - Obligations of economic operators From National Agency for the Safety of Medicines and Health Products (ANSM) ๐ซ๐ท Reference document FAQ MD regulation - Economic operator obligations in your application process 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 February 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Registering medical devices in the national database From Ministry of Health (Italy) (MDS) ๐ฎ๐น The medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and medical devices, although mandatory from the date of application of the Regulation, cannot be met according to theโฆ 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 January 13, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
"Presentation of the National Register of Medical Devices (NOR) and other distributor obligations" online conference held on 21 October 2021 in the framework of the EFOP-1.8.10-VEKOP-17-2017-00001 project From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A summary of an online conference discussing distributor obligations within the EFOP-1.8.10-VEKOP-17-2017-00001 project on 21 October 2021. 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 December 9, 2022 Other (Public Domain) 0 reuses 0 favorites
Notice to industry: Medical devices contained in electronic health record (EHR) products From Health Canada ๐จ๐ฆ This notice is for manufacturers of EHR software products and EHR-based medical devices. Through this notice, Health Canada wants to remind manufacturers of their regulatory obligations for EHR-based medical devices in Canada. 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 October 31, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
MDR Newsletter 24/2021: "Presentation of the National Register of Medical Devices (NOR) and other obligations of distributors" online conference held on 21 October 2021 From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A newsletter discussing the National Register of Medical Devices (NOR) and distributor obligations, presented at an online conference on October 21, 2021. 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 2, 2022 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 14/2021: Information for distributors (responsibilities, obligations under MDR) From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A newsletter providing information for distributors on their responsibilities and obligations under the Medical Device Regulation (MDR) in issue 14 of 2021. 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 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Guidance document with information on the obligations of Importers and Distributors under the Medical Device Regulations (EU) 2017/745 & 746. From National Organization for Medicines (EOF) ๐ฌ๐ท Please be informed that the document "MDCG 2021-27 - Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746" has been published on the European Commission's website, providing ... 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 December 14, 2021 Other (Public Domain) 0 reuses 0 favorites