Source: https://www.tga.gov.au/publication/business-rules-reduced-assessment-fees-ivds
Timestamp: 2018-03-18 00:42:19
Document Index: 9756167

Matched Legal Cases: ['art 3', 'art 1', 'art 4', 'art 3', 'art 4', 'art 1', 'art 4', 'art 3', 'art 1', 'art 4', 'art 1', 'art 4', 'art 1', 'art 4', 'art 2', 'art 4', 'art 4', 'art 4']

Business rules for reduced assessment fees for IVDs | Therapeutic Goods Administration (TGA)
Print version of Business rules for reduced assessment fees for in vitro diagnostic medical devices (IVDs) (pdf, 360 KB)
On this page: Version history | Overview | Abridged assessments | Registered IVDs currently supplied in Australia | Other IVDs that have been evaluated by the TGA | Decisions regarding abridgement | Determination of reduced fees | Appendix 1 - Business rules for reduced fees | Copyright
V1.0 Update of fees, formatting of document into new template IVD section 29/08/2011
V1.1 Update to show reduced fees as a percentage of the full fees. IVD team 25/07/2012
where the request is attached to an eBS application, a statement that evidence to support the request will be included in the submission documentation.
In this section: Business rule 1(a) | Business rule 1(b) | Business rule 1(c) | Business rule 2(a) | Business rule 2(b) | Business rule 3 | Business rule 4(a) | Business rule 4(b) | Business rule 4(c) | Business rule 5(a) | Business rule 5(b) | Business rule 6(a) | Business rule 6(b) | Business rule 7(a) | Business rule 7(b) | Business rule 8
Application Audits (Technical File Reviews)
Effective applications received by the TGA on the same day; and
submitted by the same sponsor; and
have the same manufacturer; and
the IVDs are similar in nature.
The standard information package (STED) normally required for a TFR must essentially be common for each of the IVDs covered, except for labelling, instructions for use, and any other information specific to the individual IVDs.
The level of reduced fee will be determined on a case-by-case basis. The amount of assessment required will inform this decision.
An application for a point of care testing analyser is submitted at the same time as a separate application for a number of Class 2 chemistry test strips for use on the analyser. Both applications must be selected for audit (TFR) under Regulation 5.3. The first TFR will attract the full fee but the fee for additional TFRs can be reduced.
Full prescribed fee for one IVD requiring a mandatory TFR
This rule applies to a single application for inclusion in the ARTG covering multiple IVDs some or all of which may be subject to a mandatory TFR. The IVDs do not necessarily need to share the same STED.
The TGA will select one or more of the IVDs to undergo review.
A group of Chlamydia IVDs incorporating several different methodologies, e.g. tests utilising a nucleic acid technology and an immunoassay-based technology, may be selected for review due to the significant differences between products.
Full prescribed fee for first IVD requiring a mandatory TFR
Reduction of fees for a TFR is possible for HIV and HCV assays currently registered in the ARTG where they are intended to monitor patients with active infections. These include HIV or HCV quantitative nucleic acid tests for performing viral loads or genotyping assays.
The IVD for inclusion in the ARTG must be the same IVD that is currently registered, and must not include any changes that will require detailed assessment as part of the TFR.
An HIV or HCV quantitative nucleic acid test (viral load assay) or an HIV or HCV genotyping assay that is currently registered in the ARTG.
Reduced fee for mandatory TFR requiring basic administrative review only - 12% of the full fee
applying for Full QMS or Production QA certification; and
holds a current unconditional Manufacturing licence issued under Part 3-3 of the Therapeutic Goods Act 1989; and
the scope of the Manufacturing licence includes the IVD(s) that is to be assessed; and
the assessment for the Manufacturing licence incorporated the same quality management system elements as required for an assessment for TGA conformity assessment certification;
then the fees may be reduced.
This rule applies when a manufacturer applying for a TGA conformity assessment certificate (Full QMS or Production QA) already holds a relevant Manufacturing licence. Although the QMS will have already been reviewed, aspects such as compliance with the Essential Principles, risk analysis and performance data will not have been reviewed previously by the TGA. These and other aspects essential for issuing a TGA conformity assessment certificate may require further assessment, the extent of which will be determined as part of the pre-assessment process.
Fees set will be consistent with the assessment activity required to be performed. In general, the full fee will be required if an on-site audit is performed, although reduced fees will apply if the licensing audit is done in conjunction with the conformity assessment audit.
An Australian manufacturer who holds a current TGA-issued Manufacturing licence for production of IVDs containing material of human origin.
Reduced fee for conformity assessment under Schedule 3, Part 1 or Part 4 - 30% of the full fee
holds a current unconditional Manufacturing licence issued under Part 3-3 of the Therapeutic Goods Act 1989 and a TGA conformity assessment certificate issued under Part 4-4 of the Therapeutic Goods Act 1989; and
the manufacturer has been selected for a surveillance audit for the purpose of maintaining the conformity assessment certificate; and
an audit has been performed for the Manufacturing license within the previous 12-18 months; and
the scope of the Manufacturing licence audit included the quality management system under which the IVDs are manufactured, as defined in the initial conformity assessment certification; and
the outcome of the audit resulted in an unconditional continuation of the Australian Manufacturing licence;
then the assessment may be abridged and the fees reduced.
This rule applies when a manufacturer already holds a relevant Australian Manufacturing licence and a TGA conformity assessment certificate. If a surveillance audit for the conformity assessment certificate is due but the manufacturer has undergone a licensing audit within the previous 12-18 months which resulted in an unconditional continuation of that Manufacturing licence, then a reduction of fees may be possible.
Reduced fee for conformity assessment surveillance audit under Schedule 3, Part 1 or Part 4 - 5% of the full fee
holds current EC certification issued by a European Notified Body under Annex IV or Annex VII of the in-vitro diagnostic medical devices Directive 98/79/EC (IVDD); and
the assessment undertaken by the Notified Body incorporated the same elements of an assessment as required for a Full QMS or Production QA conformity assessment certificate issued by the TGA; and
an initial assessment or surveillance audit has been undertaken by the Notified Body within the previous 12-18 months;
then the TGA conformity assessment may be abridged and fees reduced accordingly.
This rule applies when an Australian manufacturer already has an EC certificate to Annex IV or VII of the IVDD and an associated audit was conducted by the Notified Body who issued the certificate within the previous 12-18 months.
It is expected that manufacturers who may be eligible under this rule will be subject to a shortened audit if an audit is applicable.
Once a TGA conformity assessment certificate for quality systems has been issued to an Australian manufacturer, all future surveillance audits or the assessment of a change to a quality management system or, if required, a change to an IVD will be performed by the TGA.
An Australian manufacturer produces an IVD for screening for phenylketonuria. The IVD is included in List B, Annex II of the IVDD and accordingly the manufacturer has EC Annex IV IVDD certification.
the assessment undertaken by the Notified Body incorporated the same elements of an assessment as required for a Full QMS or Production QA conformity assessment certificate issued by the TGA;
then the assessment may be abridged and fees reduced accordingly.
This rule applies to manufacturers who hold an EC Certificate to Part 3 of either Annex IV or Annex VII of the IVDD. The TGA will review the audit reports and other relevant manufacturer’s documentation.
This rule will only apply where the TGA has experience with both the manufacturer and the manufacturer's technology - new manufacturers or current manufacturers undertaking manufacture of a device using technology that is new to the manufacturer will normally be audited by the TGA.
As the legislation requires that the TGA issues a conformity assessment certificate for Class 4 IVDs, the TGA will apply this rule on a case-by-case basis, depending on the IVD involved, the technology used and the TGA's knowledge of the manufacturer.
A European IVD manufacturer of an HBsAg enzyme immunoassay (which is included on List A of Annex II of the IVDD) holds relevant EC Certification but requires a TGA issued conformity assessment certificate.
holds both a current TGA conformity assessment certificate and current EC certification issued by a European Notified Body under Annex IV or Annex VII of the in-vitro diagnostic medical devices Directive 98/79/EC (IVDD); and
the manufacturer has been selected for a review of the conformity assessment certificate (surveillance audit) by the TGA; and
the assessment undertaken by the Notified Body incorporated the same elements required to be reviewed for a conformity assessment certificate (surveillance audit) and the surveillance audit has been undertaken within the previous 12-18 months;
This rule applies when a manufacturer holds both a current TGA conformity assessment certificate and EC certification. If a surveillance audit was recently performed by a Notified Body to maintain the EC certificate, then abridgement may be possible for the TGA conformity assessment certificate surveillance audit which is now required.
If the relevant Notified Body has not audited the overseas manufacturer within the preceding 12-18 months, then the TGA would normally conduct an on-site surveillance audit at full fees. It is therefore beneficial for a manufacturer to ensure that surveillance audits are conducted within the required period.
Reduced fee for conformity assessment surveillance audit under Schedule 3, Part 1 or Part 4 - 10% of the full fee
holds both a TGA conformity assessment certificate and current EC certification issued by a European Notified Body under Annex IV or Annex VII of the in-vitro diagnostic medical devices Directive 98/79/EC; and
the manufacturer plans to implement a significant change to the quality management system; and
the change has been satisfactorily addressed and approved by the Notified Body;
This rule applies when a manufacturer holds both a TGA issued conformity assessment certificate and EC certification. If major changes to the QMS are proposed, and these have already been reported to, assessed and approved by the Notified Body responsible for the EC certification, then abridgement for the changes to the TGA conformity assessment certificate may be possible.
An overseas manufacturer holding both an EC certificate and a TGA issued conformity assessment certificate intends to move manufacturing sites. The Notified Body responsible for the EC certification has already assessed and approved this change.
Reduced fee for review of conformity assessment under Schedule 3, Part 1 or Part 4 - 25% of the full fee
holds ISO 13485 certification that is issued by a CMDCAS Registrar recognised by the TGA under the MoU with Health Canada;
then the assessment will be abridged and fees reduced accordingly.
QMS certificates issued by a participating Registrar who has undergone a mutual confidence building exercise with the TGA will allow for abridgement of the QMS component of an application for a TGA-issued conformity assessment certificate.
Product assessment appropriate to the class of the IVD(s) covered by the application is required.
Further information on the operation of the reciprocal arrangement between the TGA and Health Canada can be found on the TGA website
holds ISO 13485 certification that is issued by a CMDCAS Registrar who is NOT recognised by the TGA under the MoU with Health Canada;
This rule applies to manufacturers who hold a QMS certification issued by a CMDCAS Registrar who has not undergone particular training to the requirements of Australian legislation. The TGA will conduct assessment of the manufacturer's QMS, but may abridge the examination if appropriate assessment reports and other relevant manufacturer's documentation are available.
This rule will only apply where the TGA has experience with both the manufacturer and the manufacturer's technology - new manufacturers or current manufacturers undertaking manufacture of an IVD using technology that is new to the manufacturer will normally be audited by the TGA.
Reduced fee for conformity assessment surveillance audit under Schedule 3, Part 1 or Part 4 - will be determined following consideration of the manufacturer's documentation supplied in support of the application.
If an Australian or overseas manufacturer of an IVD that is currently registered in the ARTG submits an initial application for a conformity assessment certificate including examination of design; and
the evaluation of the IVD conducted as part of the Registration process incorporated the same elements of an assessment as required for Design Examination certification;
then the reduced assessment fee for abridged Design Examination, as prescribed in Schedule 5, may apply.
This rule applies to manufacturers of HIV assays and HCV assays that are registered in the ARTG.
An application for Design Examination for a HCV or HIV assay with a current AUST R number.
Reduced fee for conformity assessment (Design Examination) under Schedule 3, Clause 1.6 - as prescribed in Schedule 5, Item 1.9A (d) of the Regulations
If an Australian or overseas manufacturer of an IVD that is currently listed or exempt under Chapter 3 of the Therapeutic Goods Act 1989 submits an initial application for a conformity assessment certificate including examination of design ; and
local data exists in a format acceptable to the TGA that will result in a reduced assessment of performance data;
This rule applies to a manufacturer applying for a Design Examination certificate for an IVD that has been in use for a number of years.
Data which has been generated in Australia or from an Australian representative population should be compiled by the manufacturer so that it is suitable for demonstrating compliance with the relevant Essential Principles for safety and performance. The clinical evidence should demonstrate that all locally relevant characteristics and/or population variants have been taken into account, and it should be presented in a format consistent with that described in the guidance document What a manufacturer needs to know about conformity assessment for IVDs.
The extent of abridgement of performance testing and the fee reduction depends upon the extent of information available and will be determined on a case-by-case basis.
An HTLV assay that has been in use in Australia over many years. The assay is used in blood donor screening and requires a TGA issued Design Examination certificate as a Class 4 IVD. Data held by the manufacturer can be used to support the assay's performance claims.
Conformity assessment (Design Examination) under Schedule 3, Clause 1.6
holds current EC certification issued by a European Notified Body under Annex V of the in-vitro diagnostic medical devices Directive 98/79/EC (IVDD) or a Class III or IV Medical Device Active Licence Listing (MDALL) for an IVD that is issued by Health Canada under the Canadian Medical Devices Regulations; and
the assessment undertaken by the Notified Body or Health Canada incorporated the same elements of an assessment as required for a Type Examination certification;
If an IVD manufactured overseas has an EC Certificate to Annex V of the IVDD, or a Canadian product licence issued by Health Canada, it may be possible to reduce fees for the assessment of an application for a TGA-issued Type Examination certificate.
A Class 3 software IVD in use worldwide for many years has an EC certificate to Annex V and Annex VII of the IVDD. The Annex V (Type Examination) certificate will be considered in an application for a Type Examination by the TGA.
Reduced fee for conformity assessment (Type Examination) under Schedule 3, Part 2 - 20% of the full fee
holds current EC certification issued by a European Notified Body under Annex IV part 4 of the in-vitro diagnostic medical devices Directive (98/79/EC) or a Class IV Medical Device Active Licence Listing (MDALL) for an IVD that is issued by Health Canada under the Canadian Medical Devices Regulations; and
the assessment undertaken by the Notified Body or Health Canada for the issue of a product licence incorporated the same elements of an assessment as required for Design Examination certification;
If an overseas manufacturer of a Class 4 IVD not currently registered in the ARTG holds a current EC Design Examination certificate (Annex IV, part 4) or a Canadian product licence issued by Health Canada, and the assessment reports are available to the TGA for review, then provided it is not also required to undergo performance testing by the TGA it may be possible to reduce fees for the assessment of an application for a TGA issued Design Examination certificate.
An overseas manufacturer of a Hepatitis B surface antigen enzyme immunoassay (included on List A of Annex II of the IVDD) holds EC Certification issued under Annex IV, part 4.
Reduced fee for conformity assessment (Design Examination) under Schedule 3, Clause 1.6 - 25% of the full fee
submits an initial application for Design Examination certification; and
the kind of IVDs under this activity which would require individual conformity assessment are similar enough for the assessment to be concurrently conducted; and
one of the devices in the application is subject to full conformity assessment;
This rule applies to a single manufacturer applying for TGA Design Examination certificates for a number of related IVDs which are sufficiently similar for the assessments to be conducted simultaneously. The first IVD is subject to full evaluation fees for the Design Examination certificate, but the evaluation fees for each subsequent related application that is submitted at the same time may be reduced.
Suitability for reduced assessment fees on the basis of similarity will be determined on a case-by-case basis and is dependent on the submission of appropriate information to substantiate the request.
A manufacturer with a range of HIV assays which incorporate antibody testing and antigen/antibody combination testing using the same technology.
Reduced fee for conformity assessment (design examination) under Schedule 3, Clause 1.6 - 10% of the full fee
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