System User Manual From Ministry of Food and Drug Safety (MFDS) ๐ฐ๐ท A comprehensive guide detailing instructions and information on how to effectively use and navigate a system. 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
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 886 Ophthalmic Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 886 Ophthalmic Devices". 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
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) ๐บ๐ธ A regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 870 Cardiovascular Devices". 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
CPG Sec 390.100 Definition of โCommerceโ - 21 CFR 1000.3(d) 2 From Food and Drug Administration (FDA) ๐บ๐ธ A Compliance Policy Guide outlining the definition of "Commerce" as per 21 CFR 1000.3(d) 2. 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
Compliance Policy Guides Index From Food and Drug Administration (FDA) ๐บ๐ธ A document outlining an index of Compliance Policy Guides (CPG) for regulatory compliance purposes. 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
Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11 From Food and Drug Administration (FDA) ๐บ๐ธ A document outlining the process for the Secretary to determine non-compliance or defects in products, referencing 21 CFR 1003.11. Part of Compliance Policy Guide (CPG). 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 160.100 Regulatory Actions and Small Business From Food and Drug Administration (FDA) ๐บ๐ธ CPG Sec. 160.100 provides guidance on regulatory actions and their impact on small businesses. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021) From Food and Drug Administration (FDA) ๐บ๐ธ This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021)". 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document for small entities on complying with amendments to the Mammography Quality Standards Act and Regulations, aimed at industry 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 not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 month ago Other (Public Domain) 0 reuses 0 favorites
Medical device reforms: five questions to ask before you get a medical implant From Therapeutic Goods Administration (TGA) ๐ฆ๐บ When considering an implant, the guide helps consumers ask the right questions. 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 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
E-cigarette and Vape Advice for Retailers / Producers From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง The MHRA provides advice for Retailers and Producers of e-cigarette / vape products. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Support swissdamed From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Document providing support and information on the topic of "swissdamed". 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Transparency for machine learning-enabled medical devices: Guiding principles From Health Canada ๐จ๐ฆ Guiding principles for good medical device machine learning practice developed by Health Canada, the US Food and Drug Administration and the United Kingdomโs Medicines and Healthcare products Regulatory Agency. 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 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guiding principles: Predetermined change control plans for machine learning-enabled medical devices From Health Canada ๐จ๐ฆ FDA, Health Canada and MHRA jointly identified 5 guiding principles for predetermined change control plans, drawing upon GMLP guiding principles, particularly stating that deployed models are monitored for performance and re-training risks are managed. 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 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Authorised Prescriber: online system From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (SAS & AP online system) is the preferred method of submission for AP applications. 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guide to Fees for Human Products From Health Products Regulatory Authority (HPRA) ๐ฎ๐ช A guidance document outlining fees associated with human products. 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 3, 2024 Other (Public Domain) 0 reuses 0 favorites
Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document for laboratory manufacturers and FDA staff on compliance with regulations for Laboratory Developed Tests (LDTs). 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 24, 2024 Other (Public Domain) 0 reuses 0 favorites
NOR registration for custom-made device manufacturers From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A guide outlining the registration process for manufacturers of custom-made medical devices in the NOR. 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 (Public Domain) 0 reuses 0 favorites
Online assessment tool and online notification form From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Use our online assessment tool and notification form to transition to the new EU MDR, so you can continue supplying 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 on June 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Machine learning medical devices: transparency principles From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Guidelines for communicating clear and relevant information about machine learning-enabled 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 on June 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites