Medical Devices From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices 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 week ago Other (Public Domain) 0 reuses 0 favorites
Registration of actors From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Registration of actors 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, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Extra-EU actors registration From Ministry of Health (Italy) (MDS) 🇮🇹 Medical Devices - Extra-EU actors registration 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, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
NOR registration for custom-made device manufacturers From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 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
Registration of implantable medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Date of publication: June 13, 2023 The purpose of the National Implant Registries is to provide information for the greater effectiveness of the Medical Devices Vigilance System by making it possible to quickly locate patients carrying a given implant. Likewise, this information contributes to the… 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 27, 2024 Other (Public Domain) 0 reuses 0 favorites
Expression of Interest for Medical Device Registration Voluntary Feasibility Study From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Version 1 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 May 17, 2024 Other (Public Domain) 0 reuses 0 favorites
Registration on the list of custom-made medical device manufacturers From Ministry of Health (Italy) (MDS) 🇮🇹 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 portal… 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
Distributor registration From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A document outlining the process and requirements for medical devices distributors. 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 9, 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
EUDAMED – User guides and templates From European Commission 🇪🇺 This document provides user guides and templates for EUDAMED, a system for medical device registration and monitoring in the EU. 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 April 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED – Manage From European Commission 🇪🇺 This document provides guidance on managing the European Database on Medical Devices (EUDAMED), covering key aspects and procedures for effective utilization. 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 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED – Actor registration From European Commission 🇪🇺 This document provides guidelines and instructions for registering actors in the EUDAMED system, ensuring compliance with regulatory 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 on March 20, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of 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 March 18, 2024 Other (Public Domain) 0 reuses 0 favorites
Registration of in vitro diagnostic medical devices in the national database From Ministry of Health (Italy) (MDS) 🇮🇹 Waiting for the fully functionality of European Database Eudamed , at the moment in Italy the obligations provided for in Article 10 of Legislative Decree 332/2000 shall continue to apply, untill twenty-four months after the date of the publication of the notice on the functionality of Eudamed. 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 14, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
TR-02 R3 Contents of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB From Health Sciences Authority (HSA) 🇸🇬 Medical device technical reference document, focusing on product registration submission for IVD medical devices. 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 March 1, 2024 Other (Public Domain) 0 reuses 0 favorites
TR-01 R3 Contents of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB From Health Sciences Authority (HSA) 🇸🇬 Medical device technical reference document, focusing on product registration submission for general medical devices. 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 March 1, 2024 Other (Public Domain) 0 reuses 0 favorites
GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB From Health Sciences Authority (HSA) 🇸🇬 Guidance document on preparing a product registration submission for IVD MD using ASEAN CSDT. 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 March 1, 2024 Other (Public Domain) 0 reuses 0 favorites
GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB From Health Sciences Authority (HSA) 🇸🇬 Provides guidance on preparing a product registration submission for GMD using the ASEAN CSDT. 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 March 1, 2024 Other (Public Domain) 0 reuses 0 favorites
GN-15-R11 Guidance on Medical Device Product Registration (2024 Mar) PUB From Health Sciences Authority (HSA) 🇸🇬 Provides guidelines on product registration for medical devices. 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 March 1, 2024 Other (Public Domain) 0 reuses 0 favorites
Evaluation of sterilants and disinfectants From Therapeutic Goods Administration (TGA) 🇦🇺 These historical guidelines describe the information to be supplied for the registration or listing of disinfectants and sterilants in the Australian Register of Therapeutic Goods (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 February 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites