Public Inspection: Revocation of Regulations: Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2024-21559. Scheduled to be published on 2024-09-20. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency 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 1 day ago Other (Public Domain) 0 reuses 0 favorites
GMP Audit Reminders From Ministry of Food and Drug Safety (MFDS) ๐ฐ๐ท Get reminders for GMP audits with this 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 3 weeks ago Other (Public Domain) 0 reuses 0 favorites
Desktop audit (DTA) and on-site inspection From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Under the Medical Device Vigilance Program, we will conduct desktop audits and on-site inspections. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 820 Quality System Regulation From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 820 Quality System Regulation". 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Prepare for a medical device application audit From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Find out when an application audit may be conducted and understand the audit assessment 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 April 23, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Application audit (technical file review) of IVD medical device applications From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Prepare for a technical file review as part of your application to include an in vitro medical device in the Australian Register of Therapeutic Goods. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Quality management system audits and certification guidance From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit 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 December 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Medical Device Single Audit Program (MDSAP) From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The MDSAP allows recognised organisations to audit device manufacturers in a single program that satisfies the requirements of the participating regulatory authorities. 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
Frequently asked questions for the Medical Device Single Audit Program (MDSAP) From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections From Food and Drug Administration (FDA) ๐บ๐ธ CPG Sec. 130.300: FDA's access to quality assurance program audits and inspections results. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on September 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Inspection and audit feedback forms From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Find further information about inspection and audit feedback forms. On this page they are available in pdf and Microsoft Word formats to download. 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 1, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment certificates, changes to requirements for certain medical devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The conformity assessment certification and audit requirements for certain medical devices have changed. 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 September 17, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Questions and Answers related to MDCG 2020-4: โGuidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictionsโ From European Commission ๐ช๐บ Get answers to questions about MDCG 2020-4 guidance on temporary measures for medical device notified body audits during COVID-19 restrictions. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) From European Commission ๐ช๐บ This document provides guidance for notified bodies on using MDSAP audit reports during surveillance audits under MDR/IVDR. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Resolution - RE No. 392 of 20/02/2018 From Brazilian Health Regulatory Agency (Anvisa) ๐ง๐ท Recognizes the Medical Device Single Audit Program (MDSAP), to subsidize health inspection and surveillance actions. 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 April 21, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions From European Commission ๐ช๐บ Get guidance on temporary measures for medical device notified body audits during COVID-19 quarantine and travel restrictions. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Medical Device Regulatory Audit Reports From International Medical Device Regulators Forum (IMDRF) ๐ Technical document: IMDRF/MDSAP WG/N24FINAL:2015 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 on October 2, 2015 Other (Public Domain) 0 reuses 0 favorites
MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes From International Medical Device Regulators Forum (IMDRF) ๐ Information document IMDRF/MDSAP WG/N22FINAL:2014. 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 on September 18, 2014 Other (Public Domain) 0 reuses 0 favorites
GMP Audit Status From Ministry of Food and Drug Safety (MFDS) ๐ฐ๐ท Overview of the status of Good Manufacturing Practice audits. 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 26, 2024 Other (Public Domain) 0 reuses 0 favorites
GMP Audit Organizations From Ministry of Food and Drug Safety (MFDS) ๐ฐ๐ท This document provides information on organizations that conduct Good Manufacturing Practice (GMP) audits. 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 26, 2024 Other (Public Domain) 0 reuses 0 favorites