Annual reports From Therapeutic Goods Administration (TGA) π¦πΊ Information on annual reporting requirements for sponsors of 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 January 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Recalls annual report 2019-20 From Therapeutic Goods Administration (TGA) π¦πΊ Insights into therapeutic goods safety regulatory activity for our recalls program. 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 25, 2023 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 803 Medical Device Reporting From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 803 Medical Device Reporting". 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
National Medical Device Adverse Event Surveillance Annual Report (2020) From National Medical Products Administration (NMPA) π¨π³ FGWJ-2021-10001 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 29, 2021 Other (Public Domain) 0 reuses 0 favorites
Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Annual Reports for Approved Premarket Approval Applications (PMA)" for industry and FDA staff. It covers administrative/procedural and premarket topics. 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 20, 2020 Other (Public Domain) 0 reuses 0 favorites
1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers". 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
National Medical Device Adverse Event Surveillance Annual Report (FY2016) From National Medical Products Administration (NMPA) π¨π³ FGWJ-2017-10142 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 10, 2017 Other (Public Domain) 0 reuses 0 favorites