Medical Device Approval Australia – TGA
Information & Training. | Medical Devices.The following are the steps to Medical Device Approval in Australia, to ensure compliance with the regulatory requirements of the Australian Therapeutic Goods Administration (TGA).
Stage 1: Concept – Consider the Essential Principles
Stage 2: Prototype – Incorporate the Essential Principles into the design
Stage 3: Preclinical – Seek approval from or notify the TGA of intention to commence clinical trial
Stage 4: Clinical –
Follow clinical trial guidelines
Prepare clinical evaluation of clinical data
Stage 5: Manufacturing – Apply conformity assessment procedures and then obtain appropriate conformity assessment evidence
Stage 6: Marketing – Adhere to the Therapeutic Goods Advertising Code
Stage 7: Supply –
Apply to include the device in the ARTG
Monitor safety and performance of the device during its lifetime
Maintain conformity assessment evidence
Report any problems with the device to the TGA and to the users of the device
Recall and/or correct devices that have defects, design flaws, or unacceptable clinical risks or levels of performance
Stage 8: Obsolescence – Notify the TGA so the device can be removed from the ARTG
Information & Training.
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>