Passing Preliminary Assessment for Medical Device Applications – TGA Process

Purpose of Preliminary Assessment

The preliminary assessment is the first formal check performed by the TGA after an application for conformity assessment or ARTG inclusion is lodged. Its primary objectives are to:

• Confirm the application is complete and correctly formatted.
• Verify basic eligibility and compliance with lodgement requirements.
• Identify obvious deficiencies early to avoid unnecessary full reviews.

Passing this stage does not indicate that the application will ultimately be approved; it only means it meets threshold requirements to proceed to technical evaluation. Source: Passing preliminary assessment for medical device applications - TGA

Key Elements Checked During Preliminary Assessment

The TGA examines several critical aspects:

• Correct Application Type and Fees: Confirmation that the application matches the intended regulatory pathway and that appropriate fees have been paid.
• Completeness of Submission: All required modules, forms, declarations, and supporting documents are present.
• Format and Structure: Application follows TGA-specified structure, file naming conventions, and electronic submission requirements.
• Device Description and Classification: Basic consistency between claimed classification, intended purpose, and GMDN code.
• Essential Principles Declaration: Presence of a valid declaration of conformity to Essential Principles.
• Conformity Assessment Evidence: Inclusion of required certificates or reports (e.g., ISO 13485, EU certificates where applicable).
• Australian Sponsor Details: Valid sponsor information and authorisation.

Applications are not assessed for scientific/technical merit at this stage.

Outcomes of Preliminary Assessment

• Pass: The application proceeds to full technical evaluation. Sponsors receive confirmation and an estimated review timeline.
• Fail: The TGA issues a 'Notification of Deficiencies' detailing reasons for failure. The application is not accepted for review. Sponsors may:
  • Withdraw and re-lodge a corrected version (new fees apply).
  • Request reconsideration in limited circumstances.
  • Proceed to appeal processes if applicable.

Common failure reasons include missing documents, incorrect fees, incomplete declarations, or mismatched classification claims.

Practical Tips for Sponsors

• Use TGA checklists and templates to ensure all required elements are included.
• Double-check file formats, sizes, and naming conventions before lodgement.
• Verify that all declarations are signed and dated correctly.
• Confirm payment of correct fees based on device classification and application type.
• Consider requesting a pre-submission meeting for complex applications to clarify requirements in advance.

The TGA provides detailed checklists, common deficiency examples, lodgement guides, and step-by-step instructions to help sponsors prepare applications likely to pass preliminary assessment. Source: Passing preliminary assessment for medical device applications - TGA

Passing preliminary assessment is a critical gateway that significantly improves the likelihood of a smooth and timely full review process for medical device market authorisation in Australia.