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) 🇺🇸 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 today Other (Public Domain) 0 reuses 0 favorites
Medicinal substances in medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 A medicinal substance in a medical device must meet Australian manufacturing and quality control 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 July 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 3: Medical devices to be suitable for intended purpose From Therapeutic Goods Administration (TGA) 🇦🇺 Principle 3 requires manufacturers to ensure their devices perform in the way intended. This includes the design, manufacturing process, and packaging. 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 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
National Symposium on Point-of-care Manufacturing of medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Read the meeting summary for the National Symposium on Point-of-care Manufacturing of medical devices, held on 19 June 2023. 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Annual charges From Therapeutic Goods Administration (TGA) 🇦🇺 Information about annual charges for product entries on the Australian Register of Therapeutic Goods (ARTG) and manufacturing licences. 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, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 801 Labeling From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 801 Labeling". 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
Guide for Health institutions Who Manufacture and Use In-house IVDs in Ireland From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document for health institutions in Ireland on manufacturing and using in-house in vitro diagnostics (IVDs). 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 May 24, 2024 Other (Public Domain) 0 reuses 0 favorites
Point-of-care Manufacturing of Medical Devices Complex Manufacturing Hubs in Healthcare Facilities Working Group, Meeting Statement, Meeting 1, 1 December 2023 From Therapeutic Goods Administration (TGA) 🇦🇺 A meeting statement from the Point-of-care Manufacturing of Medical Devices Complex Manufacturing Hubs in Healthcare Facilities Working Group is now available. 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Point-of-care Manufacturing of Medical Devices Allied Health Sector Working Group Meeting Statement, Meeting 1, 27 November 2023 From Therapeutic Goods Administration (TGA) 🇦🇺 A meeting statement from the Medical Devices Allied Health Sector Working Group is now available. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Point-of-care Manufacturing of Medical Devices Dental Sector Working Group, Meeting Statement, Meeting 1, 29 November 2023 From Therapeutic Goods Administration (TGA) 🇦🇺 A meeting statement from the Dental Sector Working Group is now available. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Point-of-care manufacturing of medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Information and guidance about the regulation of point-of-care manufacturing 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 April 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Point-of-care Manufacturing of Medical Devices Steering Committee, Meeting statement, Meeting 1, 17 November 2023 From Therapeutic Goods Administration (TGA) 🇦🇺 A meeting statement from the first meeting of the Point-of-care Manufacturing of Medical Devices Steering Committee is now available. 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 April 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Australian manufacturing licences and overseas GMP certification From Therapeutic Goods Administration (TGA) 🇦🇺 A step-by-step guide for Australian manufacturers of therapeutic goods. 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 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TIWGG meeting summaries From Therapeutic Goods Administration (TGA) 🇦🇺 TGA-Industry Working Group on Good Manufacturing Practice (TIWGG) meeting summaries. 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 22, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-01709. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align… 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 2, 2024 Other (Public Domain) 0 reuses 0 favorites
(MDS – G009) Guidance for Points of Care (POC) Medical Devices Manufacturing From Saudi Food and Drug Authority (SFDA) 🇸🇦 Guidance on manufacturing POC 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 January 25, 2024 Other (Public Domain) 0 reuses 0 favorites
Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products From Therapeutic Goods Administration (TGA) 🇦🇺 The Australian Code of Good Manufacturing Practice (GMP) for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products (the Code) applies to Blood, Human Tissues and Human Cellular Therapy Products manufacturers that undertake the collection, processing, testing, storage,… 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 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
GMP clearance guidance From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site. 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 11, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on notifying FDA of permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act. 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 November 16, 2023 Other (Public Domain) 0 reuses 0 favorites
Standards of Medical Device Good Manufacturing Practices_Revised From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Standards of Medical Device Good Manufacturing Practices_Revised 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 17, 2023 Other (Public Domain) 0 reuses 0 favorites