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
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for laboratory manufacturers and FDA staff on enforcement policy for certain in vitro diagnostic devices during public health emergencies without a Section 564 declaration. Focuses on outbreak response. 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 April 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Statutory advisory committee forms From Therapeutic Goods Administration (TGA) 🇦🇺 This form is to be submitted with the expression of interest when applying for membership to a TGA expert committee. 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 22, 2024 Other (Non-Commercial) 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
GN-15-R11 Guidance on Medical Device Product Registration (2024 Mar) PUB From Health Sciences Authority (HSA) 🇸🇬 Provides guidelines on product registration for 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 March 1, 2024 Other (Public Domain) 0 reuses 0 favorites
Unique device identification system From Ministry of Health (Italy) (MDS) 🇮🇹 The unique device identification system ("UDI system") provided for in the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Devices (IVD) Regulation (EU) 2017/746 allows for the identification and facilitates the traceability of devices. The system involves: assigning a basic… 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 12, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Australian declaration of conformity templates (IVDs) From Therapeutic Goods Administration (TGA) 🇦🇺 Templates for manufacturers to make Australian Declarations of Conformity for an in vitro diagnostic medical device. 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 From Office of Parliamentary Council Australia 🇦🇺 Document F2023L01088. 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 3, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Therapeutic Goods (Articles that are Not Medical Devices) Amendment (Vaping) Declaration 2023 From Office of Parliamentary Council Australia 🇦🇺 Document F2023L01682. 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 3, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Common issues identified during clinical trial applications From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them. 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 6, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
CPG Sec.140.500 Metric Declarations of Quantity of Contents on Product Labels From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "CPG Sec.140.500 Metric Declarations of Quantity of Contents on Product Labels". It covers labeling regulations. 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 September 29, 2023 Other (Public Domain) 0 reuses 0 favorites
GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB From Health Sciences Authority (HSA) 🇸🇬 Covers licensing requirements for manufacturers, importers and wholesalers 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 July 1, 2023 Other (Public Domain) 0 reuses 0 favorites
FAQ Regulation MD - Declaration From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document FAQ MD regulation - Declaration in your application 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 February 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
GN-11-R1.3_Guidance on the Declaration of Conformity(2022 Nov)_PUB From Health Sciences Authority (HSA) 🇸🇬 Provides guidance on the topic of Declaration of Conformity for 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 November 1, 2022 Other (Public Domain) 0 reuses 0 favorites
Declaration of Conformity (DOC) to “Medical Devices Law” and its Executive Regulation From Saudi Food and Drug Authority (SFDA) 🇸🇦 Declaration of Conformity (DOC) 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 December 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Australian declaration of conformity templates (medical devices) From Therapeutic Goods Administration (TGA) 🇦🇺 Information and templates for manufacturers making an Australian declaration of conformity. 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 November 29, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Guidance for manufacturer's declaration of conformity for system or procedure packs From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance applies to manufacturers of medical devices that are regulated as 'system or procedure packs' and supplied using the special conformity assessment procedure regulatory pathway. 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 26, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Guidance for Declaration of Conformity Procedures From Therapeutic Goods Administration (TGA) 🇦🇺 Self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export. 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 26, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Annual Charge Exemption scheme From Therapeutic Goods Administration (TGA) 🇦🇺 The Annual Charge Exemption (ACE) declaration period occurs between 1 July and 22 July. 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 30, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Announcement on the Medical Devices Regulation (EU)2017/745 From National Organization for Medicines (EOF) 🇬🇷 Following the Announcement of 17/3/2021 regarding the Medical Devices Regulation (EU)2017/745, a Model Declaration of Conformity ... 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 27, 2021 Other (Public Domain) 0 reuses 0 favorites