Information session on the pilot for expert panels' advice for orphan medical devices From European Medicines Agency (EMA) πͺπΊ An upcoming event discussing a pilot program for expert panels' advice on orphan medical devices. 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 2 days ago Other (Public Domain) 0 reuses 0 favorites
Combined studies From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Document covers various studies, focusing on clinical trials. 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 2 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Performance studies From Swiss Agency for Therapeutic Products (Swissmedic) π¨π This document discusses performance studies, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Clinical investigations From Swiss Agency for Therapeutic Products (Swissmedic) π¨π This document discusses clinical investigations, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Announcements From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Various announcements on clinical trials, clinical investigation etc. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
E-cigarette and Vape Advice for Retailers / Producers From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The MHRA provides advice for Retailers and Producers of e-cigarette / vape products. 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 August 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 10 - general advice on vigilance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Collecting and acting on information on any adverse effects of electronic cigarette devices and refill containers on human health. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Pre-submission Advice & Support From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations. 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 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Breast Implant Expert and Consumer Working Groups From Therapeutic Goods Administration (TGA) π¦πΊ The working group aims to provide clinical advice on breast implant and tissue expander medical devices to the TGA, including advice on breast implant associated cancer. 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Advice for health procurement teams about therapeutic goods and medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Guidance for procurement areas in hospitals, aged care residential facilities and other facilities. 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 23, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices Safety Update From Therapeutic Goods Administration (TGA) π¦πΊ MDSU provides practical advice and information about medical device safety. 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 January 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulatory decisions and notices (medical devices & IVDs) From Therapeutic Goods Administration (TGA) π¦πΊ Regulatory decisions, notices and advice for industry about medical devices and IVDs 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 20, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Systems that are medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Advice about systems that are medical devices for sponsors and manufacturers. 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
Brexit - Implications for therapeutic goods in Australia From Therapeutic Goods Administration (TGA) π¦πΊ Advice on the implications of Brexit for therapeutic goods supply 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 September 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Clinical trials From Swiss Agency for Therapeutic Products (Swissmedic) π¨π This document discusses clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
EMA pilots scientific advice for certain high-risk medical devices From European Medicines Agency (EMA) πͺπΊ EMA is testing scientific advice for high-risk 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 February 27, 2023 Other (Public Domain) 0 reuses 0 favorites
Information session on the pilot for expert panelsβ scientific advice to manufacturers of high-risk medical devices From European Medicines Agency (EMA) πͺπΊ Information session on pilot for expert panels' scientific advice to manufacturers of high-risk medical devices. 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 February 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Innovation Accelerator From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
ACMD advice on Hepatitis C and Human Immunodeficiency Virus point of care tests From Therapeutic Goods Administration (TGA) π¦πΊ The TGA asked the ACMD to consider acceptable levels of sensitivity and specificity for Hepatitis C (HCV) and Human Immunodeficiency Virus (HIV) PoCTs 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
Chapter 9 - General advice on due diligence Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ General advice on due diligence - electronic cigarettes devices and refill containers. 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, 2022 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites