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New format for TGA conformity assessment certificates

13 October 2011

In early 2011, the TGA Devices Authorisation Branch started issuing new electronic conformity assessment certificates to medical device manufacturers. The new format and design of the conformity assessment certificates incorporate the following features and improvements:

  • The addition of a version/change history table provides a record of the changes made to the certificate over its lifetime, improves transparency of decision making by detailing the TGA file number associated with each change to the certificate, and helps manufacturers and sponsors keep track of changes made to the certificate.
  • For most certificates the current list of specific GMDN codes in the scope of the quality certificate will be replaced by a list of product types (e.g. 'pacemakers and accessories'). This should result in a reduction of the need for submitting change requests concerning the scope of the certificate.
  • The incorporation of suppliers, categories, and products into the body of the certificate (rather than having separate schedules for each) improves the general management of the certificates, makes it easier for sponsors to lodge manufacturers' evidence, and helps with management of changes to certificates.
  • Incorporation of the scope of each of the manufacturer's facilities into the certificate, and the scope of that activity, help to clarify which aspects of design and manufacture are provided by each facility.
  • The addition of page numbers (x of y) into the footer of every certificate ensures that all pages of certificates are present and complete when sponsors or manufacturers submit applications.
  • The standard conditions are included at the end of each certificate to provide an easy reference for the manufacturer.
  • The certificates are no longer physically signed by the issuing delegate. This has multiple advantages. As the certificates are generated directly as a PDF (rather than by scanning in a signed hard copy) all text is easy to cut and paste directly into application forms, letters, and other electronic documents. The certificates are faster to generate and issue by the delegate. This improves time frames of certification and reduces publication errors.
  • The ODA no longer issues hard copies of conformity assessment certificates; however, manufacturers may still print certificates from the PDF file as required. When issuing certificates in the new format, the ODA will notify the manufacturer and applicant of the above changes.

Attachment

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Example Part 1 Full Quality Assurance conformity assessment certificate (pdf,539kb)*

Please note: the example certificate is indicative only and is completely fictional.