Market Access

Australia - TGA

Expert Guidance for Medical Device Registration with the TGA

Expanding your medical device business into Australia requires compliance with the Therapeutic Goods Administration (TGA) regulations. At Alpine Quality Consultants, we provide expert regulatory support to ensure a smooth and compliant market entry for your medical devices in Australia.

Our TGA Medical Device Registration Process

Device Classification & Regulatory Pathway Determination

  • Identify device classification (Class I, Is, Im, IIa, IIb, III, AIMD) as per TGA requirements.
  • Determine the appropriate regulatory pathway (ARTG listing, conformity assessment, or overseas recognition).
  • Develop a customized compliance strategy for market entry.

Appointing an Australian Sponsor

  • Assist in appointing an Australian-based sponsor, a requirement for non-Australian manufacturers.
  • Ensure compliance with local sponsor responsibilities and regulatory communication.

Technical File Preparation & Submission

  • Compile the technical documentation in accordance with Essential Principles and ISO 13485.
  • Ensure alignment with existing approvals (CE Marking, FDA clearance, MDSAP) where applicable.
  • Submit the TGA application for inclusion in the Australian Register of Therapeutic Goods (ARTG).

TGA Assessment & Approval

  • Coordinate with TGA during application reviews and audits.
  • Address additional information requests and liaise with authorities for a smooth approval process.
  • Obtain ARTG listing or TGA Conformity Assessment Certification for market entry.

Post-Market Surveillance & Compliance

  • Support in adverse event reporting (Medical Device Incident Reporting - MDIR).
  • Ensure compliance with post-market surveillance (PMS) and product recalls if required.
  • Assist in renewals, modifications, and ongoing regulatory updates.
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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