What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
Unique device identification system From Ministry of Health (Italy) (MDS) ๐ฎ๐น 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 basicโฆ 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) ๐ฆ๐บ 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
GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB From Health Sciences Authority (HSA) ๐ธ๐ฌ 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
GN-11-R1.3_Guidance on the Declaration of Conformity(2022 Nov)_PUB From Health Sciences Authority (HSA) ๐ธ๐ฌ 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
Conformity of assessment body DoC template From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ Version 1 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 30, 2022 Other (Public Domain) 0 reuses 0 favorites
Declaration of Conformity (DOC) to โMedical Devices Lawโ and its Executive Regulation From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ 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) ๐ฆ๐บ 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) ๐ฆ๐บ 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) ๐ฆ๐บ 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
Announcement on the Medical Devices Regulation (EU)2017/745 From National Organization for Medicines (EOF) ๐ฌ๐ท 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
Provision No. 2275/06 From National Administration of Drugs, Food and Medical Devices (ANMAT) ๐ฆ๐ท Products for in vitro diagnostic use - Abbreviated procedure for the declaration of conformity in relation to the information requirements for the registration of the mentioned products of groups A and B, according to provision 2674/99 of national manufacture, or imported from any of the countriesโฆ 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 January 1, 2006 Creative Commons Attribution 4.0 0 reuses 0 favorites