Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2024-10895. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA isโฆ Metadata quality: Metadata quality: Data description filled 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: 77.77777777777779/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
Safety announcements from medical device manufacturers From Danish Medicines Agency (DKMA) ๐ฉ๐ฐ Number of entries: 5154 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 days ago Other (Public Domain) 0 reuses 0 favorites
COVID-19 rapid antigen self-tests (for home use) From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information for sponsors, manufacturers and consumers on COVID-19 rapid antigen tests for self-testing 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 3 days ago Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 in vitro diagnostics - Guidance on ongoing requirements for sponsors and manufacturers From Therapeutic Goods Administration (TGA) ๐ฆ๐บ A guide for sponsors of COVID-19 IVDs about their ongoing obligations 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 days ago Other (Non-Commercial) 0 reuses 0 favorites
Clinical trials From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ This document discusses clinical trials. 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 days ago Other (Non-Commercial) 0 reuses 0 favorites
Artificial Intelligence (AI) and medical device software From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information for software manufacturers when AI is considered a medical device, and how we regulate AI medical devices. 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 1 week ago Other (Non-Commercial) 0 reuses 0 favorites
Software and artificial intelligence (AI) as a medical device From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). 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 2 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 809 In Vitro Diagnostic Products for Human Use From Food and Drug Administration (FDA) ๐บ๐ธ Regulation on in vitro diagnostic products for human use under 21 CFR Chapter I Subchapter H - Medical Devices - Part 809. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Laboratory Developed Tests From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2024-08935. The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.โฆ 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Authorization to Open Overseas Manufacturer Account Form From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ A form for authorizing the opening of an overseas manufacturer account. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Learn about quality management systems From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Learn about Quality Management Systems and how medical device manufacturers use them to meet their regulatory and customer 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Essential Principles checklist From Therapeutic Goods Administration (TGA) ๐ฆ๐บ A checklist to help medical device manufacturers prove compliance with the Essential Principles 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 (Non-Commercial) 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) ๐บ๐ธ 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 3 weeks ago Other (Public Domain) 0 reuses 0 favorites
In vitro diagnostic medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) ๐ช๐ธ Last updated: April 26, 2024 An in vitro diagnostic medical device is any medical device consisting of a reagent, reagent product, calibrator, control material, kit of instruments and materials, instrument, apparatus, equipment or system, used alone or in association with others, intended by theโฆ 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 3 weeks ago Other (Public Domain) 0 reuses 0 favorites
Registration on the list of custom-made medical device manufacturers From Ministry of Health (Italy) (MDS) ๐ฎ๐น Manufacturers who make bespoke medical devices available on the national territory notify the Ministry of Health of their identification data and the list of bespoke medical devices (Article 7, paragraph 1 of Legislative Decree 137/2022), through the online service accessible from the portalโฆ 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 18, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Draft Australian UDI Bulk Upload Template From Therapeutic Goods Administration (TGA) ๐ฆ๐บ A Microsoft Excel template for sponsors and manufacturers for uploading bulk UDI records to the Australian UDI Database 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Guidance document on GMP compliance by foreign manufacturers. 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 April 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations From Health Canada ๐จ๐ฆ 2006 Health Canada guidance document providing guidance for medical devices manufacturers on the use of standards in demonstrating compliance with the Safety and Effectiveness Requirements and Labelling Requirements of the Canadian Medical Devices Regulations 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 15, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Economic operators From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Learn about economic operators and their role in reporting incidents and FSCAs (vigilance). 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 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Real World Evidence (RWE) From Therapeutic Goods Administration (TGA) ๐ฆ๐บ This guidance intends to outline for sponsors and manufacturers the types of RWE relevant in the Australian context. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites