Category
Guidance Document
Organisation
Type
Standard
Version
1
Access
Open
Status
Active
Created
Aug 2018
To reduce regulatory burden on the Australian medical device industry, the Therapeutic Goods Administration allows instructions for use of medical devices to be provided electronically in certain circumstances. This also aligns with similar regulators, such as Health Canada, the United States Food and Drug Administration and the European Commission.
This guideline aims to support manufacturers and sponsors who supply instructions for use of their medical devices via their website or other electronic format.
Main sections:
· Definitions
· Information that must be provided with a medical device
· Requirements for the provision of eIFU
This guideline aims to support manufacturers and sponsors who supply instructions for use of their medical devices via their website or other electronic format.
Main sections:
· Definitions
· Information that must be provided with a medical device
· Requirements for the provision of eIFU
Access Electronic Instructions for Use – eIFU v1.0
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