Principle 3: Medical devices to be suitable for intended purpose From Therapeutic Goods Administration (TGA) 🇦🇺 Principle 3 requires manufacturers to ensure their devices perform in the way intended. This includes the design, manufacturing process, and packaging. 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 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Off-label use of medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 'Off-label use' is using a product for the purposes not included in the intended purpose in the 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 October 16, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Crafting an intended purpose in the context of Software as a Medical Device (SaMD) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations. 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 22, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
TGA regulatory framework From Therapeutic Goods Administration (TGA) 🇦🇺 It's important that Australians have access to quality therapeutic goods that are safe to use and fulfil their intended purpose. 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 1, 2020 Other (Non-Commercial) 0 reuses 0 favorites