Public Inspection: Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2024-21575. Scheduled to be published on 2024-09-20. Metadata quality: Metadata quality: Data description empty 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: 66.66666666666666/100 Updated today Other (Public Domain) 0 reuses 0 favorites
Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ A draft guidance document by the FDA and industry on chemical analysis for assessing biocompatibility of medical devices, covering CMC and premarket topics. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated today 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
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 864 Hematology and Pathology 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 864 Hematology and Pathology 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
Consultation on the International Council for Harmonisation (ICH) M14 From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Consultation on the ICH E2D(R1) guidelines on General principles on plan, design, and analysis of pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
ICH guideline M10 on bioanalytical method validation and study sample analysis From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have adopted this International Scientific Guideline - ICH M10; EMA/CHMP/ICH/172948/2019 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 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on reporting the results of population pharmacokinetic analyses From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have adopted this International Scientific Guideline - CHMP/EWP/185990/06 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 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products From Food and Drug Administration (FDA) ๐บ๐ธ Guidance document outlining the purpose and content of use-related risk analyses for drugs, biological products, and combination products. 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 July 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices manufactured at the point-of-care - Analysis of survey results by sector From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Access our report on medical devices manufactured at the point-of-care - analysis of survey results by sector. 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 (Non-Commercial) 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) ๐ฎ๐น Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy,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 on June 5, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 801 Labeling From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ 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
Normative Instruction - IN no. 290 of 04/04/2024 From Brazilian Health Regulatory Agency (Anvisa) ๐ง๐ท Establishes, under the terms of Collegiate Board Resolution - RDC No. 741, of August 10, 2022, an optimized procedure for the analysis and decision of medical device registration petitions, through the use of analyses carried out by an Equivalent Foreign Regulatory Authority (AREE). Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample Analysis From Food and Drug Administration (FDA) ๐บ๐ธ This document is titled "CPG Sec. 150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample Analysis" and it is a 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 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
How tests and testing kits for coronavirus (COVID-19) work From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง The different types of tests and testing kits for COVID-19, and the specifications for manufacturers. 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 August 8, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Ordinance - PRT No. 511 of 30/09/2021 From Brazilian Health Regulatory Agency (Anvisa) ๐ง๐ท Defines the chronological criteria for analysis or approval of registration or notification processes for products defined as medical devices, within the scope of the National Health Surveillance Agency. Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on July 12, 2023 Other (Public Domain) 0 reuses 0 favorites
Reporting system for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) ๐ฎ๐น The Ministry of Health carries out the activities of monitoring and investigating reports from healthcare professionals and manufacturers. On Sept. 28, 2022, Legislative Decree No. 138 of Aug. 5, 2022 , came into force, which in Article 13 provides fulfillments for manufacturers of in vitroโฆ 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 3, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 874 Ear, Nose, and Throat 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 874 Ear, Nose, and Throat 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 on January 9, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Cardiovascular Devices; Classification of the Photoplethysmograph Analysis Software for Over-the-Counter Use From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2022-02358. The Food and Drug Administration (FDA, Agency, or we) is classifying the photoplethysmograph analysis software for over-the- counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part ofโฆ 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 4, 2022 Other (Public Domain) 0 reuses 0 favorites
Guidance on summary reports and issue-related analyses for medical devices: Overview From Health Canada ๐จ๐ฆ Requirements for evaluating the safety and effectiveness (how well they work) before and after a medical device is authorized for sale in Canada. 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 January 14, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Submissions received: Scope of regulated software based medical devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Report on feedback to recent public consultation on the scope of regulated software 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 17, 2020 Other (Non-Commercial) 0 reuses 0 favorites