Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document titled "Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product". It focuses on combination products. 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 August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 884 of 26/06/2024 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Amends Collegiate Board Resolution RDC No. 591, of December 21, 2021. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on July 1, 2024 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 879 of 28/05/2024 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Prohibits the manufacture, import and marketing, as well as the use in health services, of mercury and powder for non-encapsulated amalgam alloys indicated for use in dentistry. 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 June 3, 2024 Other (Public Domain) 0 reuses 0 favorites
Normative Instruction - IN no. 290 of 04/04/2024 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 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
Collegiate Board Resolution - RDC No. 848 of 06/03/2024 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the essential safety and performance requirements applicable to medical devices and in vitro diagnostic (IVD) medical devices. 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 March 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 837 of 13/12/2023 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for clinical investigations with medical devices in Brazil. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on December 15, 2023 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 830 of 06/12/2023 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for risk classification, notification and registration regimes, labeling requirements and instructions for use for in vitro diagnostic medical devices, including their instruments. 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 December 11, 2023 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 825 of 26/10/2023 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Establishes the minimum identity and quality requirements for surgical gloves and gloves for non-surgical procedures made of natural rubber, synthetic rubber, a mixture of natural and synthetic rubbers and polyvinyl chloride, under the health surveillance regime. 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 October 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 810 of 17/08/2023 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Amends Collegiate Board Resolution - RDC No. 751, of September 15, 2022, which provides for risk classification, notification and registration regimes, and labeling requirements and instructions for use of medical devices. 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 August 18, 2023 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 777 of 01/03/2023 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Amends Collegiate Board Resolution - RDC No. 751, of September 15, 2022, which provides for risk classification, notification and registration regimes, and labeling requirements and instructions for use of medical devices. 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 March 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 751 of 15/09/2022 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for risk classification, notification and registration regimes, labeling requirements and instructions for use of medical devices. 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 September 21, 2022 Other (Public Domain) 0 reuses 0 favorites
ACMD 2012/1 meeting resolutions From Therapeutic Goods Administration (TGA) 🇦🇺 Advisory Committee on Medical Devices, Meeting 2012/1 resolutions 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 21, 2022 Other (Non-Commercial) 0 reuses 0 favorites
ACMD 2011/3 meeting report & resolutions From Therapeutic Goods Administration (TGA) 🇦🇺 Advisory Committee on Medical Devices, Meeting 2011/3 report and resolutions 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 21, 2022 Other (Non-Commercial) 0 reuses 0 favorites
ACMD 2011/1 meeting report & resolutions From Therapeutic Goods Administration (TGA) 🇦🇺 Advisory Committee on Medical Devices, Meeting 2011/1 report and resolutions 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 21, 2022 Other (Non-Commercial) 0 reuses 0 favorites
ACMD 2010/3 meeting report & resolutions From Therapeutic Goods Administration (TGA) 🇦🇺 Advisory Committee on Medical Devices, Meeting 2010/3 report and resolutions 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 21, 2022 Other (Non-Commercial) 0 reuses 0 favorites
ACMD 2010/2 meeting report & resolutions From Therapeutic Goods Administration (TGA) 🇦🇺 Advisory Committee on Medical Devices, Meeting 2010/2 report and resolutions 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 21, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 687 of 13/05/2022 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the criteria for granting or renewing the Good Manufacturing Practice Certification for Medical Devices. 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 May 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 657 of 24/03/2022 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the regularization of software as a medical device (SaMD) Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 31, 2022 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 608 of 25/02/2022 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the compassionate use of medical devices. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 594 of 28/12/2021 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the requirements for grouping implantable materials in orthopaedics for registration purposes and makes other provisions. 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 January 3, 2022 Other (Public Domain) 0 reuses 0 favorites