International Recognition Procedure From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ How to use the procedure for medicines licensing applications. 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 3 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
The Target Development Profile Toolkit From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines. 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 5, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Innovative Licensing and Access Pathway From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient 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 April 5, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guidance on the Procedures for Licensing of Medical Devices and Supplies Establishments From Saudi Food and Drug Authority (SFDA) πΈπ¦ A document providing guidance on the procedures for licensing medical devices and supplies establishments. 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 January 22, 2024 Other (Public Domain) 0 reuses 0 favorites
Guideline on Questions and Answers Licensing of Medical Device Establishments From South African Health Products Regulatory Authority (SAHPRA) πΏπ¦ Document Number SAHPGL-MD-07 - Version 3 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 November 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices From Ministry of Food and Drug Safety (MFDS) π°π· This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyzeβ¦ 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 July 20, 2023 Other (Public Domain) 0 reuses 0 favorites
GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB From Health Sciences Authority (HSA) πΈπ¬ Covers licensing requirements for manufacturers, importers and wholesalers of 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 July 1, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on the licensing of biosimilar products From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ This guideline is to provide developers of biosimilar products with a clear outline of the requirements in Great Britain. 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 7, 2022 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Requirements for Licensing of Medical Devices Establishments (MDS-REQ9) From Saudi Food and Drug Authority (SFDA) πΈπ¦ Regulation: Requirements for Licensing of Medical Devices Establishments. 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 August 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Alternative licensing and regulatory pathway for masks From South African Health Products Regulatory Authority (SAHPRA) πΏπ¦ Document Number MD025 - 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 September 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19 From South African Health Products Regulatory Authority (SAHPRA) πΏπ¦ Document Number MD025 - 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 September 22, 2020 Other (Public Domain) 0 reuses 0 favorites
Alternative Regulatory Licensing Requirements Alcohol-based sanitisers From South African Health Products Regulatory Authority (SAHPRA) πΏπ¦ Document Number MD009 - 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 July 17, 2020 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration Office on strengthening the medical device production and management licensing (for the record) information management of the relevant work notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2020-1662 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 2, 2018 Other (Public Domain) 0 reuses 0 favorites
Private Label Medical Devices From Health Canada π¨π¦ Health Canada questions and answers on medical device licensing regulatory requirements 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 14, 2011 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Administrative Licensing Law of the People's Republic of China (Presidential Decree No. 7) (amended) From National Medical Products Administration (NMPA) π¨π³ FGWJ-2011-10633 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 9, 2011 Other (Public Domain) 0 reuses 0 favorites
Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices From Health Canada π¨π¦ Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices 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 2, 2009 Open Government License 2.0 (Canada) 0 reuses 0 favorites
GN-03-R3 Guidance on Preparation of a Site Master File for Licensing From Health Sciences Authority (HSA) πΈπ¬ Provides detailed instructions on creating a site master file for licensing purposes. 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 17, 2024 Other (Public Domain) 0 reuses 0 favorites
International licensing information From Ministry of Food and Drug Safety (MFDS) π°π· Get the latest information on international licensing for various industries and sectors. 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 7, 2024 Other (Public Domain) 0 reuses 0 favorites