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What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs

Version 1.0, November 2011

24 November 2011

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Documentation for applications

Documentation for applications - Quality Management System documentation

Manufacturers who apply for a TGA Conformity Assessment Certificate will be requested to complete a supporting data form and provide documents that detail specific parts of their quality management system. As a guide, documentation that is generally requested includes:

  • Copy of the latest version of the Quality Manual (as required under ISO 13485:2003, clause 4.2.2
  • Organisational chart (if not part of QM)
  • Product requirements (specifications) for the products included in the scope of the certificate
  • A list of critical suppliers and a description of how purchasing requirements are fulfilled (ISO 13485:2003, clause 7.4.1)
  • Plans of the manufacturing facility or facilities
  • List of critical processes and the status of their validation (ISO 13485:2003, clause 7.5.2.1). If the product is supplied sterile, a copy of sterilisation validation reports
  • Procedure for a feedback system (ISO 13485:2003, clause 8.2.1, Regulations for post market requirements)
  • Procedure for the issue and implementation of advisory notices and notification of adverse events (ISO 13485:2003, clause 8.5.1, Uniform recall procedure for therapeutic goods)
  • Documents providing the basis for any reduction in assessment fees applied for by the applicant.

Documentation for applications - Summary Technical Documentation (STED)

Manufacturers who apply for a TGA Conformity Assessment Certificate are required to hold technical documentation to demonstrate that each device complies with the Essential Principles.

The Global Harmonisation Taskforce (GHTF) has released the Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices (STED), which provides guidance on the technical documentation that should be assembled and submitted to demonstrate conformity to the Essential Principles. While it is not mandatory for manufacturers to adhere to all the recommendations outlined in the GHTF STED document, it provides useful guidance on the documentation which may be requested and examined by the TGA (at on-site audit or by submission) for the product assessment component of a conformity assessment. The GHTF STED guidance can be accessed at:

Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices (pdf,157kb)

Where an application for conformity assessment covers a number of IVDs, the TGA will review the technical documentation for a sample of the IVDs. The technical documentation to be assessed, and the level of detail required, will vary on a case by case basis depending on:

  • classification of the IVD
  • complexity of the IVD
  • period that it has been on the market
  • whether the IVD has the following characteristics:
    • it incorporates a novel technology
    • it is an already marketed IVD type that is now being offered for an intended purpose different from the original one
    • it incorporates novel or potentially hazardous materials
    • the IVD type raises specific public health concerns.

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