Manufacturers of medical devices must ensure their medical devices consistently meet safety, performance, and quality requirements.
Manufacturers of certain medical devices must put in place a formal Quality Management System (QMS) and have the system independently certified.
Key information
- Learn about quality management systemsPageLearn about Quality Management Systems and how medical device manufacturers use them to meet their regulatory and customer requirements.
Related information
- Quality, safety, and performance requirements for medical devicesPageMedical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.
- Obtain and maintain regulatory evidencePageUnderstand what evidence is needed to have a medical device included in the Australian Register of Therapeutic Goods (ARTG).
- Manufacture specific types of medical devicesSectionInformation and guidance on the regulation and manufacture of specific types of medical devices.
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