Fees in Respect of Drugs and Medical Devices Regulations - SOR/2011-79 From Department of Justice Canada 🇨🇦 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
Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number MD01-2024/2025 - Version 1 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 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Request for certificates or certified copies of TGA licences and certificates From Therapeutic Goods Administration (TGA) 🇦🇺 Use this form to request for certificates or certified copies of TGA licences and certificates 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Annual charges From Therapeutic Goods Administration (TGA) 🇦🇺 Information about annual charges for product entries on the Australian Register of Therapeutic Goods (ARTG) and manufacturing licences. 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
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
Australian manufacturing licences and overseas GMP certification From Therapeutic Goods Administration (TGA) 🇦🇺 A step-by-step guide for Australian manufacturers of therapeutic goods. 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 April 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance for PHMCA / HCSA Licensees and Telemedicine Service Providers: Advertisement Controls of Health Products and Provision of Non-Promotional Information to the Public From Health Sciences Authority (HSA) 🇸🇬 Guidance document for PHMCA/HCSA licensees and telemedicine service providers on advertisement controls and providing non-promotional health product information to the public. 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 August 21, 2023 Other (Public Domain) 0 reuses 0 favorites
Guideline for a License to Manufacture, Import, Export, or Distribute Medical Devices and IVDs From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number SAHPGL-MD-06 - Version 3 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 March 23, 2023 Other (Public Domain) 0 reuses 0 favorites
Technical health committee - Section for the issuance of licenses for healthcare advertising From Ministry of Health (Italy) (MDS) 🇮🇹 This document discusses the Technical Health Committee's role in issuing licenses for healthcare advertising and promotional activities. 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 17, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Healthcare advertising licenses From Ministry of Health (Italy) (MDS) 🇮🇹 This document discusses healthcare advertising licenses and focuses on advertising and promotional activities in the healthcare industry. 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
GN-35-R4 Guidance on Special Access Routes (2023 Jan) PUB From Health Sciences Authority (HSA) 🇸🇬 Document providing guidance on special access routes for medical devices. 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 March 17, 2024 Other (Public Domain) 0 reuses 0 favorites
What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023 From Health Canada 🇨🇦 Medical Devices Establishment License bulletin outlining the annual licence review process for 2023. 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 December 2, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on user fees and refunds for premarket approval applications and device biologics license applications. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 19, 2022 Other (Public Domain) 0 reuses 0 favorites
S38 guidelines for Australian manufacturing licences covering multiple manufacturing sites From Therapeutic Goods Administration (TGA) 🇦🇺 This document provides guidelines for Australian manufacturing licenses that cover multiple manufacturing sites. 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, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Off-label advertising and sale of COVID-19 rapid antigen tests under workplace screening initiative: Interim enforcement approach From Health Canada 🇨🇦 Medical Devices Establishment License bulletin outlining the interim enforcement approach to off-label advertising and sale of rapid antigen tests under workplace screening program 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 12, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Health Canada launches electronic manufacturer's certificate to export From Health Canada 🇨🇦 Medical devices establishment license bulletin outlining the launch of an electronic version of the manufacturer's certificate to export 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 4, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
What MDEL holders need to know about annual licence review for 2022 From Health Canada 🇨🇦 Medical Devices Establishment License bulletin outlining the annual licence review process for 2022. 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 December 14, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Failure to pay 2021 annual licence review fees will result in cancellation of MDELs From Health Canada 🇨🇦 Medical Devices Establishment License bulletin outlining the cancellation of MDELs for failure to pay fees. 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 3, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance Document: Medical Device Licence Renewal and Fee for the Right to Sell Licensed Medical Devices From Health Canada 🇨🇦 2013 Health Canada guidance document 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 September 24, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Cancellation of MDELs for failure to pay fees From Health Canada 🇨🇦 Medical Devices Establishment License bulletin outlining the cancellation of MDELs for failure to pay fees. 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, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites