Export certificates (Free Sales Certificates) From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Learn about export certificates, including free sales certificates, and other related certificates. 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 2 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Disinfectants, sterilants and sanitary products From Therapeutic Goods Administration (TGA) 🇦🇺 How sterilants and disinfectants are regulated in Australia. List of relevant legislation. 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 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Custom-made devices and Regulation (EU) 2017/745 From Ministry of Health (Italy) (MDS) 🇮🇹 As of May 26, 2021, the Regulation (EU) 2017/745, which entered into force on May 25, 2017, applies to custom-made medical devices in a harmonized manner in all member states. The Legislative Decree of August 5, 2022, No. 137 adapts national legislation to the provisions of the regulation and… 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 12, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Legal framework From Therapeutic Goods Administration (TGA) 🇦🇺 Information on advertising legislation and how we manage advertising compliance. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Active implantable medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 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 research… 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
Standards orders and medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 The Australian medical devices legislation creates a system of non-mandatory medical device standards orders (MDSO) and conformity assessment standards orders (CASO) that can be used to demonstrate compliance. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Legislation and legislative instruments From Therapeutic Goods Administration (TGA) 🇦🇺 Find information about legislation, acts and regulations, legislative instruments and other legislative information. 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 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Medical device notices and standards orders From Therapeutic Goods Administration (TGA) 🇦🇺 If you intend to rely on any legislation referred to on this website, you should access copies of the official versions 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 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 From Therapeutic Goods Administration (TGA) 🇦🇺 The Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 was approved by the Executive Council on 23 November and was registered on the Federal Register of Legislation on 27 November 2023. 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 7, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Clinical evidence guidelines From Therapeutic Goods Administration (TGA) 🇦🇺 These guidelines provide details and guidance on the clinical evidence requirements for medical devices, including In Vitro Diagnostic medical devices (IVDs), under Australian legislation. 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 23, 2023 Other (Non-Commercial) 0 reuses 0 favorites
About the Australian therapeutic goods legislation From Therapeutic Goods Administration (TGA) 🇦🇺 Legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia. 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 October 23, 2023 Other (Non-Commercial) 0 reuses 0 favorites
In vitro diagnostic medical devices: guidance on legislation From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic 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 July 17, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
The Medical Devices (Amendment) (Great Britain) Regulations 2023 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain. The 2002 Regulations were made under section 2(2) of 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 June 9, 2023 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Evaluation procedures for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 As of May 26, 2022, Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council, repealing Directive 98/79/EC and Commission Decision 2010/227/EU, is applicable with some exceptions. On September 28, 2022, Legislative Decree No. 138 of August 5, 2022 on the adaptation of national… 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 20, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Export of medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 To export medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs), you must meet requirements set out in the Australian therapeutic goods legislation. 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 25, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Case studies From Therapeutic Goods Administration (TGA) 🇦🇺 These case studies provide practical examples that demonstrate our guidance, legislation and policy in action. 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 29, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Restricted representations From Therapeutic Goods Administration (TGA) 🇦🇺 Updated to reflect the current legislation. 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 October 8, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 From Therapeutic Goods Administration (TGA) 🇦🇺 This is the first package of regulatory changes for the broader medical device reforms 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 23, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Legislation From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 Amendments to the legislation regarding the entry into force of the MDR and IVDR. 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 December 18, 2019 Other (Public Domain) 0 reuses 0 favorites
Legislation, guidelines From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 List of legislations and guidelines related to 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 December 5, 2019 Other (Public Domain) 0 reuses 0 favorites