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
FAQ Regulation MD From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document FAQ MD regulation 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 July 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Advertising health services and cosmetic injections: frequently asked questions and answers From Therapeutic Goods Administration (TGA) π¦πΊ Find out answers to frequently asked questions about advertising cosmetic injection services and our guidelines. 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 22, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Q&As on conditions of supply for rapid antigen point of care COVID-19 tests From Therapeutic Goods Administration (TGA) π¦πΊ Answers to frequently asked questions in relation to rapid antigen point-of-care tests. 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
Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators From Food and Drug Administration (FDA) πΊπΈ An information sheet providing guidance for Institutional Review Boards and Clinical Investigators on Good Clinical Practice (GCP) FAQs. 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 April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Frequently Asked Questions From Swiss Agency for Therapeutic Products (Swissmedic) π¨π FAQ on regulations for medical devices. 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 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Reformatting Product Information: Frequently asked questions From Therapeutic Goods Administration (TGA) π¦πΊ Update about the transitionary arrangements for reformatting product information, including accessing a fee waiver 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Frequently asked questions for the Medical Device Single Audit Program (MDSAP) From Therapeutic Goods Administration (TGA) π¦πΊ Read our questions and answers for sponsors and manufacturers about the Medical Device Single Audit Program (MDSAP). 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Notification of IVDs From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Notification of IVDs for 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 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on Questions and Answers Licensing of Medical Device Establishments From South African Health Products Regulatory Authority (SAHPRA) πΏπ¦ Document Number SAHPGL-MD-07 - 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 November 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Guidance document providing answers to frequently asked questions about accepting clinical data for medical device applications and submissions. 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 August 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Advertising Code FAQs From Therapeutic Goods Administration (TGA) π¦πΊ Frequently asked questions on the 2021 Advertising Code. 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 27, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Custom-made devices guide/concepts - Frequently Asked Questions (FAQ) From National Institute of Pharmacy and Nutrition (OGYΓI) ππΊ A document providing answers to common queries about custom-made medical devices. 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Regulatory framework for personalised medical devices: Frequently asked questions From Therapeutic Goods Administration (TGA) π¦πΊ Frequently asked questions to further clarify the new regulatory framework for personalised 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 May 9, 2023 Other (Non-Commercial) 0 reuses 0 favorites
MDR Newsletter 6/2022: Distributor registration - technical details, answers to frequently asked questions From National Institute of Pharmacy and Nutrition (OGYΓI) ππΊ A newsletter for the sixth month of 2022 covering distributor registration technical details and FAQs. 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
FAQ Regulation MD - Vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document FAQ MD regulation - Vigilance 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
FAQ Regulation MD - Declaration From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document FAQ MD regulation - Declaration 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
FAQ Regulation MD - Safety and performance requirements From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document FAQ MD regulation - Safety requirements and performance in your application process 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 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
FAQ Regulation MD - Obligations of economic operators From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· 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
FAQ Regulation MD - Notified bodies From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document FAQ MD regulation - Notified bodies 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