Active implantable medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) ๐ช๐ธ Last update: July 28, 2022 Contents Legislation Circulars Leaflets, instructions, forms Informative notes Documents of interest Fees Informative material 1. Legislation Spain Europe 2. Circulars Circular 7/04, regulation of clinical research with medical devices Circular 3/01, on clinical researchโฆ 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 May 27, 2024 Other (Public Domain) 0 reuses 0 favorites
Patient implant cards and information leaflets From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Patient information leaflets (PILs) and Patient Implant Cards (PICs) are required for all breast implants. 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 September 18, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Medical device patient information leaflets and implant cards From Therapeutic Goods Administration (TGA) ๐ฆ๐บ All implantable and Active Implantable Medical Devices are required to have patient information materials. 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 16, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Best practice for Patient Information Leaflets and Patient Implant Cards From Therapeutic Goods Administration (TGA) ๐ฆ๐บ In addition to the legislated requirements, there are other features of leaflet and card design that can be very helpful for patients 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 7, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Single-use medical devices: leaflet From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง What 'single-use' means and what symbol is used by manufacturers to show this. 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 December 1, 2013 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites