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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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Applications for certificates

A manufacturer should only lodge an application for a TGA Conformity Assessment Certificate when they are satisfied that their quality management system and associated technical documentation satisfies the requirements of the Therapeutic Goods (Medical Devices) Regulations 2002.

All manufacturers can lodge an application for a Conformity Assessment Certificate directly with the TGA. An overseas manufacturer may choose to engage an Australian agent to lodge the application on their behalf; however this is not a TGA requirement. Applications can also be lodged on behalf of the manufacturer by another party. The certificate is issued to the manufacturer, not the agent.

An application fee is payable for lodging the application - details of the current fees are available on the TGA website. Further fees are payable for any assessments that are required and these fees vary, depending on the conformity assessment procedures the manufacturer has chosen to use. For more information on fees please see Section - Fees and charges.

If a manufacturer has not previously obtained certification from the TGA or an EU Notified Body (or other equivalent certification) it is essential that they contact the TGA so they can obtain advice on their options for obtaining conformity assessment evidence, via:

How to lodge an application

Creating an e-business account

Before making an application, the manufacturer or an authorised person acting on behalf of the manufacturer must be a client of the TGA. This is achieved by establishing an eBusiness Services (eBS) account which is used to make electronic applications for medical devices including IVDs. The forms and instructions are at TGA eBusiness Services.

Lodging an electronic application for a TGA Conformity Assessment Certificate

Once the applicant has access to eBS, they must lodge an electronic application for a TGA Conformity Assessment Certificate. No electronic attachments should be attached to this form as the supporting information will be requested separately.

An invoice will be generated and the applicant must pay the application fee to the TGA. If a manufacturer does not pay the application fee the application will be terminated. No further fees are required at this stage. Any assessment fees applicable to the conformity assessment are calculated once the TGA determines the assessment needed and are invoiced separately to the applicant.

Submitting supporting documentation and declaration forms

Once the electronic application is lodged with the TGA and the application fee is processed, the applicant will receive a letter from the TGA with the Submission ID. The letter will include an initial request to provide supporting information that meets the following criteria:

  • Two hard copies of the supporting documentation are required. An additional copy in electronic format (on CD or DVD) is highly desirable and may assist the TGA with the assessment.
  • The supporting information must be supplied in loose-leaf binders. Plastic sleeves or stapled material are not acceptable.
  • The information should be sectioned for ease of reference, and a table of contents provided which details the content of the binder(s).
  • There should be appropriately named tab identifiers. For example, the Labelling information should be separated from the other documents by a tab identifier named Labelling Information.
  • Each page should be sequentially numbered.
  • Standard A4 paper should be used for all submissions wherever practicable. Text and tables should be prepared using margins that allow the document to be printed on A4 paper, or A3 paper where a larger format is necessary. The left hand margin should be sufficiently large that information is not obscured through binding.
  • Font sizes for text and tables should be of a style and size that are large enough to be easily legible, even after photocopying or when provided electronically.
  • Information supporting an application must be in English and legible. Where material is not originally in English a full translation must be submitted, the accuracy of which is the responsibility of the applicant.

All documentation (whether electronic or hard copies) submitted in support of the application should include the Submission ID number.

Where to deliver the information

The supporting documentation should be sent to:

By Post:
IVD Assessment Section
Office of Devices Authorisation
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606 AUSTRALIA

OR

By Courier:
IVD Assessment Section
Office of Devices Authorisation
Therapeutic Goods Administration
136 Narrabundah Lane
SYMONSTON ACT 2609 AUSTRALIA

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TGA processing of applications

Once the application and supporting information is received by the TGA, a pre-assessment of the application will be conducted. If the TGA finds that the manufacturer or the documentation is not ready for assessment the application may be terminated. If this happens the TGA will contact the manufacturer to discuss the options available. If the application is terminated the application fee will not be refunded.

Further information may be necessary to process the application. The TGA may send a formal request (under Section 41JA of the Act) for more information.

Please note: Each request for information will be accompanied with a specified timeframe for response. If the manufacturer is not able to provide the requested information within this timeframe (plus a further 10 working days) the application will lapse. If the application has lapsed, the manufacturer will need to reapply to obtain a TGA Conformity Assessment Certificate.

If the application has the necessary supporting information the manufacturer will be sent a formal acceptance letter advising that the application is suitable to proceed, and the relevant assessment fees will be invoiced.

The TGA may invoice reduced assessment fees if a request for abridgement is submitted in writing, either at the same time as the application, or as part of the dossier submitted to the TGA in response to the initial request for information. A reduction in assessment fees will only occur where there are grounds for an abridged assessment. Examples of when this might occur are:

  • where the manufacturer holds a TGA manufacturing licence and only a 'top-up’ QMS assessment is required
  • where a device was a therapeutic good for in vitro diagnostic use that was Registered in the ARTG under Chapter 3 of the Therapeutic Goods Act 1989
  • the applicant provides EU Notified Body reports of similar assessment performed under a relevant EU Directive. However, the TGA reserves the right to conduct a full assessment, with full fees, if the reports provide insufficient evidence of a thorough and comprehensive assessment.

For further information on reduction of assessment fees see Section - Business rules for reduced assessment fees for in vitro diagnostic medical devices (IVDs).

The TGA may refer the application to the Advisory Committee on Medical Devices (ACMD) for advice at anytime during the assessment process. Sponsors should be aware that the decision to refer an application to ACMD is at the TGA's discretion. If the application is referred, sponsors will be advised and invited to make further submissions to the TGA on the basis of the interim outcome of the Design Examination. Both the interim assessment by the TGA and the manufacturer's response to the interim assessment will be considered by ACMD. An additional 60 TGA working days will be added to the target evaluation time frame for applications sent for review by ACMD.

On-site audits

On-site audits are an important element of the assessment process for manufacturers who have applied for a TGA Conformity Assessment Certificate. The TGA will conduct a risk assessment on the device and the manufacturer to determine if an initial on-site audit is required to be conducted prior to the Conformity Assessment Certificate being issued. The risk assessment will take into account audits that have been conducted by EU Notified Bodies and Health Canada-recognised Registrars. The TGA will focus on the assessment of the critical production processes in the audit report, as well as any other issues that have been identified.

Mandatory conditions are imposed on all manufacturers holding a TGA Conformity Assessment Certificate and include the requirement to undergo regular reviews of their QMS. Surveillance audits will be scheduled regularly -generally at least 18 months apart and no more than five years apart. Audits may be conducted more frequently if issues arise. Fees are payable to the TGA for on-site audits.

The applicant will be notified in the formal acceptance letter if an on-site audit is required before a certificate is issued and the TGA will contact the applicant to arrange a suitable audit time.

Fit and proper persons

All applicants for a Conformity Assessment Certificate are required to self-assess whether they or certain other persons associated with the applicant meet the criteria set out in paragraph 41EC(3)(a) of the Act, and to certify the outcome by submitting this Certificate to the TGA. In deciding whether to issue a Conformity Assessment Certificate the TGA must consider whether an applicant or specified persons associated with an application has in the preceding 10 years failed to meet one or more of the specified criteria - for example, whether they have been convicted of an offence against the Act or a corresponding State law, or convicted of an offence involving fraud or dishonesty. More information about the requirements is available on the TGA website.

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