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TGA quality management system audits and certification guidance
[PDF, 516.02 KB]
TGA quality management system audits and certification guidance
[Word, 423.08 KB]
We perform audits of both domestic and overseas medical device manufacturers.
This is to make sure they follow:
- QMS standards
- the Therapeutic Goods Act 1989 - external site
- Therapeutic Goods (Medical Devices) Regulations 2002 - external site.
The Act requires manufacturers of medical devices to show conformity assessment procedures have been applied.
A manufacturer generally must implement a quality management system (QMS) based on recognised standards and the regulatory requirements and have the QMS assessed by us or a recognised conformity assessment body.
Sponsors must:
- declare that manufacturers have met their obligations
- be able to provide us with the technical and QMS documentation to support this claim.