The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Labs, and FDA Staff. 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 August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical device conformity assessment application From Therapeutic Goods Administration (TGA) 🇦🇺 Information and forms about applications for TGA conformity assessment certificates. 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 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Application instructions: Conformity assessment certification From Therapeutic Goods Administration (TGA) 🇦🇺 Updated guidance on how to apply for a conformity assessment certificate. 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 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Notified Bodies in Italy for conformity assessment From Ministry of Health (Italy) (MDS) 🇮🇹 As of November 26, 2017, provisions are applicable regarding Bodies wishing to operate under Regulation (EU) 2017/745, in the medical device sector, and under Regulation (EU) 2017/746, in the in vitro diagnostic medical device sector. Notified Bodies designated under the previous Directives are no… 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 18, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Application for Australian conformity assessment body determination form From Therapeutic Goods Administration (TGA) 🇦🇺 Online application form to become an Australian Conformity Assessment Body 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 July 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Request for certificates or certified copies of TGA licences and certificates From Therapeutic Goods Administration (TGA) 🇦🇺 Use this form to request for certificates or certified copies of TGA licences and certificates 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 July 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Determinations for Australian conformity assessment bodies From Therapeutic Goods Administration (TGA) 🇦🇺 These guidelines assist Australian corporations seeking to apply for an Australian conformity assessment body (CAB) determination for medical devices (including IVDs) by the TGA. 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA conformity assessment overview for in vitro diagnostic medical devices (IVDs) From Therapeutic Goods Administration (TGA) 🇦🇺 Information on conformity assessment of in vitro diagnostic medical devices (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 June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment procedures for immunohaematology reagents From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance outlines ARTG and conformity assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know. 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment certificate process and timeframes From Therapeutic Goods Administration (TGA) 🇦🇺 An overview for manufacturers applying for a conformity assessment certificate 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment overview From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance and links to information on conformity assessment for 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 June 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Designation, re-assessment and notification of conformity assessment bodies and notified bodies From European Commission 🇪🇺 This document discusses the designation, re-assessment, and notification of conformity assessment bodies and notified bodies. 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 June 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Australian regulatory evidence options for a medical device application From Therapeutic Goods Administration (TGA) 🇦🇺 Information on Australian evidence options including TGA conformity assessment certification. 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices 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 March 29, 2024 Other (Public Domain) 0 reuses 0 favorites
What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 Depending on the classification of a device, there are a number of different conformity assessment procedures a manufacturer may use to demonstrate compliance. 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
Standards orders and medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 The Australian medical devices legislation creates a system of non-mandatory medical device standards orders (MDSO) and conformity assessment standards orders (CASO) that can be used to demonstrate compliance. 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
System or procedure packs From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance on the regulation of system or procedure packs and using the special conformity assessment procedure. 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment, Essential Principles and consent to supply From Therapeutic Goods Administration (TGA) 🇦🇺 Conformity assessment, Essential Principles and consent to supply 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 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Quality management system audits and certification guidance From Therapeutic Goods Administration (TGA) 🇦🇺 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
Reduction of assessment fees for medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for reducing assessment fees for ARTG application audits and TGA conformity assessments of medical devices (including IVDs). 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