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
International Recognition Procedure From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ How to use the procedure for medicines licensing applications. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Essential Principles checklist From Therapeutic Goods Administration (TGA) π¦πΊ A checklist to help medical device manufacturers prove compliance with the Essential Principles 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 month 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
Travelling with medicines and medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Whether you're leaving Australia for a holiday or coming to Australia to see the sights, it's recommended that you take your medicines or medical devices with you. 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 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Standards for therapeutic vaping devices checklist From Therapeutic Goods Administration (TGA) π¦πΊ A checklist for sponsor intending to supply a therapeutic vaping device 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 March 27, 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
Is your advertising for therapeutic goods compliant? From Therapeutic Goods Administration (TGA) π¦πΊ This checklist may help you to meet your responsibility for ensuring your advertising complies with the advertising legislative 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 November 8, 2023 Other (Non-Commercial) 0 reuses 0 favorites
GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices(2023 Sep) PUB From Health Sciences Authority (HSA) πΈπ¬ Provides guidance on essential principles for safety and performance of 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 September 1, 2023 Other (Public Domain) 0 reuses 0 favorites
Checklist for Quality Manual Form From Saudi Food and Drug Authority (SFDA) πΈπ¦ A checklist for a quality manual form. 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 August 6, 2023 Other (Public Domain) 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
Conformity assessment body(cab) requirements for recognition by Sahpra checklist From South African Health Products Regulatory Authority (SAHPRA) πΏπ¦ 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 March 24, 2022 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 23/2021: Frequently asked questions and technical details for the transition to MDR - Part IV (Step-by-step registration - Checklist) From National Institute of Pharmacy and Nutrition (OGYΓI) ππΊ A newsletter discussing frequently asked questions and technical details for transitioning to MDR, focusing on step-by-step registration with a checklist. 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
Restricted representation application checklist From Therapeutic Goods Administration (TGA) π¦πΊ A compliance checklist for advertisers applying to use a restricted representation. 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 October 8, 2020 Other (Non-Commercial) 0 reuses 0 favorites
GMP Clearance questionnaire From Therapeutic Goods Administration (TGA) π¦πΊ Complete this questionnaire prior to submitting your GMP clearance application and upload it as part of your evidence package on your TGA ebusiness services portal 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, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5 From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5" for premarket assessment. 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 March 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] From Food and Drug Administration (FDA) πΊπΈ A guidance document outlining the checklist of information required for an Investigational Device Exemptions (IDE) application for refractive surgery lasers. 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 March 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology From Food and Drug Administration (FDA) πΊπΈ A guidance document for premarket mechanical lithotripters and stone dislodgers used in gastroenterology and urology. 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 March 17, 2020 Other (Public Domain) 0 reuses 0 favorites