Spotlight on Australia: Life and Health Sciences

Regulatory Routes Australia + EU Medical Devices All Classes ✓ Technical File ✓ Post market surveillance system ✓ Declaration of conformity Class I (sterile & measuring), lla, llb, III ✓ Implementation of a QMS: ⚫ Based on EN ISO 13485 • Include any additional requirements specified in the Regulations ✓ Maintenance of the QMS: Surveillance audits at regular intervals MyMedical DEPARTMENT

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