Medical devices From European Medicines Agency (EMA) πͺπΊ Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. 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 21, 2024 Other (Public Domain) 0 reuses 0 favorites
GeGant From European Medicines Agency (EMA) πͺπΊ Information about marketing authorisation application of GeGant, a device to obtain a solution containing radioactive gallium. 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 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Recall action templates From Therapeutic Goods Administration (TGA) π¦πΊ Templates to help you with your communications under the Uniform recall procedure for therapeutic goods (URPTG). 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
GN-15-R11 Guidance on Medical Device Product Registration (2024 Mar) PUB From Health Sciences Authority (HSA) πΈπ¬ 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
Notification of devitalised human tissue From Swiss Agency for Therapeutic Products (Swissmedic) π¨π This document is about the notification process for devitalised human tissue and its relevance to market access. 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 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on agreeing to prepare for the establishment of medical device packaging standardization technology focal point of the letter From National Medical Products Administration (NMPA) π¨π³ FGWJ-2023-10001 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 24, 2023 Other (Public Domain) 0 reuses 0 favorites
How to draft a direct healthcare professional communication From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs) 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 4, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Information session on the pilot for expert panelsβ scientific advice to manufacturers of high-risk medical devices From European Medicines Agency (EMA) πͺπΊ Information session on pilot for expert panels' scientific advice to manufacturers of high-risk 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 February 24, 2023 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on agreeing to prepare for the establishment of medical device reliability and maintainability standardization technology focal point of the reply letter From National Medical Products Administration (NMPA) π¨π³ FGWJ-2022-168 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on the consent to prepare for the establishment of oral digital medical device standardization technology focal point unit of the reply letter From National Medical Products Administration (NMPA) π¨π³ FGWJ-2022-164 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
GN-09-R3.6 Guidance on the Component Elements of a DHCPL (2022 May) PUB From Health Sciences Authority (HSA) πΈπ¬ Provides guidance on creating Dear Healthcare Professional Letters (DHCPL). 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 1, 2022 Other (Public Domain) 0 reuses 0 favorites
Response letter from the Comprehensive Department of the State Drug Administration on the management attributes of medical radiation protection sprays From National Medical Products Administration (NMPA) π¨π³ FGWJ-2022-148 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 29, 2022 Other (Public Domain) 0 reuses 0 favorites
Infrared (IR) thermometers: caution in use From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The MHRA has become increasingly aware of infrared thermometers being sold in the UK that do not comply with the regulations. 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 27, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Reply Letter of the Comprehensive Department of the State Drug Administration on Agreeing to Prepare for the Establishment of the Technical Reference Unit for Standardization of Traditional Chinese Medicine Devices and the Technical Reference Unit for Standardization of High-Throughput Sequencing for Medical Purposes From National Medical Products Administration (NMPA) π¨π³ FGWJ-2021-10001 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Variance from Manufacturer Report Number Format [MDR letter] From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Variance from Manufacturer Report Number Format [MDR letter]" and it discusses adverse event reporting. 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 April 27, 2021 Other (Public Domain) 0 reuses 0 favorites
All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46) From Food and Drug Administration (FDA) πΊπΈ This document is an industry letter titled "All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46)". 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 April 27, 2021 Other (Public Domain) 0 reuses 0 favorites
Reply letter from the General Department of the State Drug Administration on clarifying the classification and definition of medical chitosan (for intra-articular injection) From National Medical Products Administration (NMPA) π¨π³ FGWJ-2021-10001 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 March 31, 2021 Other (Public Domain) 0 reuses 0 favorites
Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices From Health Canada π¨π¦ Cover letter of a 1999 Health Canada Guidance document 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 March 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on the consent to prepare for the establishment of the national medical device clinical evaluation standardization technology focal point of the reply letter From National Medical Products Administration (NMPA) π¨π³ FGWJ-2020-10001 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Comprehensive Department of the State Drug Administration on the "supervision and management of medical devices business approach" Article 54 of the relevant application of the reply letter From National Medical Products Administration (NMPA) π¨π³ FGWJ-2020-10001 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 March 19, 2020 Other (Public Domain) 0 reuses 0 favorites