Clinical investigation authorization related to noninvasive Class I or Class IIa or IIb medical devices not bearing CE marking for intended use From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Submitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Submitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only) From Therapeutic Goods Administration (TGA) 🇦🇺 Submitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only). 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submitting an application in TBS (for all classes except Class I non-sterile, non-measuring medical device, Class 1 IVD medical device and Class I medical device/Class 1 IVD medical device Export Only) From Therapeutic Goods Administration (TGA) 🇦🇺 Submitting an application in TBS (for all classes except Class I non-sterile, non-measuring medical device, Class 1 IVD medical device and Class I medical device/Class 1 IVD medical device Export Only). 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 801 Labeling From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – 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
Class 1-3 in-house IVDs: using the online application form From Therapeutic Goods Administration (TGA) 🇦🇺 For sponsors who are providing their notification to the TGA of their Class 1-3 in-house IVDs 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 May 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Australian declaration of conformity templates (IVDs) From Therapeutic Goods Administration (TGA) 🇦🇺 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
Focus campaigns From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Document titled "Focus campaigns" focusing on the topic of "Market surveillance". 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 February 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices reforms: Low risk products - Class 1 medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Appropriate regulation of low risk devices improves their availability. 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 27, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on compliance dates, direct marking, and global UDI database requirements for certain devices, focusing on labeling and UDI. 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 July 22, 2022 Other (Public Domain) 0 reuses 0 favorites
Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Changes to the process for including Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG 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 12, 2022 Other (Non-Commercial) 0 reuses 0 favorites
MDR Newsletter 13/2021: For Risk Class I manufacturers From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter for manufacturers in Risk Class I, issue 13/2021 of the Medical Device Regulation (MDR) newsletter. 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 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-26924. The Food and Drug Administration (FDA or we) is classifying the pressure ulcer management tool into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of… 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 December 13, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance for manufacturer's declaration of conformity for system or procedure packs From Therapeutic Goods Administration (TGA) 🇦🇺 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) 🇦🇺 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
Medical Devices; General and Plastic Surgery Devices; Reclassification of Blood Lancets From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-25376. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class… 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 22, 2021 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Blood Lancets From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-25381. The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets… 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 22, 2021 Other (Public Domain) 0 reuses 0 favorites
General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-22041. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical staplers for internal use (formerly regulated under the classification for "manual surgical instrument for general use" and assigned the product code GAG) from class I… 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 October 8, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Device De Novo Classification Process From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-21677. The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This final rule establishes procedures and criteria related to… 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 October 5, 2021 Other (Public Domain) 0 reuses 0 favorites
NEWSLETTER FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES From National Organization for Medicines (EOF) 🇬🇷 We would like to inform you about the information sheet published on the European Commission's website and addressed to ... 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 19, 2021 Other (Public Domain) 0 reuses 0 favorites