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Regulatory requirements for in-house IVDs

Version 2.2, September 2018

11 September 2018

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Conformity assessment procedures for in-house IVDs

Conformity assessment ensures that the manufacturing processes used to make an in-house IVD (and the in-house IVD itself) comply with the regulatory requirements for quality safety and performance.

The class of an IVD determines the conformity assessment procedures a manufacturer can apply to ensure that the device is appropriately assessed, with higher class devices requiring more stringent conformity assessment procedures than lower class devices.

For in-house IVDs, there are different conformity assessment procedures (requirements) for:

The first step in determining the relevant regulatory requirements is to identify all of your in-house IVDs, and determine whether they are Class 1-3 or Class 4 by referring to the guidance: Classification of IVD medical devices.

Class 1-3 in-house IVDs

These do not need to be included in the Australian Register of Therapeutic Goods (ARTG). However, laboratories that manufacture Class 1-3 in-house IVDs must comply with the conformity assessment procedure in Part 6A, Schedule 3, of the MD Regulations.

How to comply

To meet the requirements of this procedure, the laboratory (manufacturer) must fulfil the following criteria.

Accreditation requirements
The role of NATA in Class 1-3 in-house IVD conformity assessment

NATA will assess the laboratory's quality management system against:

  • ISO: 15189 (for a medical testing laboratory), or
  • ISO 17025 (for a non-medical testing laboratory as considered by NATA on a case-by-case basis).

The medical testing laboratory accreditation program is administered by NATA in conjunction with the Royal College of Pathologists of Australasia (RCPA). NATA/RCPA accreditation to ISO 15189 is available to laboratories performing tests in various fields of human pathology including anatomical pathology (histology and cytology), chemical pathology, microbiology, haematology, immunohaematology, cytogenetics, molecular biology, immunology and assisted reproductive technologies.

Information about the medical testing laboratory accreditation program is on the NATA website (see Human pathology).

Review of technical documentation

Compliance with this standard will be taken as compliance with the relevant essential principles for the safety and performance of an IVD medical device.

  • The level of rigor for the review of selected Class 1-3 in-house IVDs will be commensurate with their risk class (i.e., higher risk Class 3 in-house IVDs will be subject to greater scrutiny than lower risk Class 1 in-house IVDs).
  • NATA may notify us of any compliance issue that has or may lead to the death or serious deterioration in the state of health of a patient, user of the in-house IVD, or another person.

Technical documentation will be reviewed by NATA inspectors as part of laboratory accreditation, but the MD Regulations also allow us to request this documentation at any time (if required).

Notification of Class 1-3 in-house IVDs

When to provide an initial notification

Laboratories that commence manufacturing Class 1-3 in-house IVDs must submit an initial (i.e., first) notification to use by 1 July of the next financial year (or within 20 working days of this date).

You can notify us at any time prior to this date, but if new in-house IVDs are introduced in the intervening period, you will need to re-notify us to cover the new in-house IVDs before this date.

Re-notification: When to update the initial notification

Re-notification applies to those laboratories that already have a current notification in place but have introduced new Class 1-3 in-house IVDs since this time. If your laboratory introduces new Class 1-3 in-house IVDs, re-notification to the TGA is required prior to 1 July of the next financial year (or within 20 working days of this date).

In practice this means that the introduction of an in-house test or test procedure used by a laboratory for a new determination or examination that is required to be added to the laboratory's NATA test list also requires notification to us (by 1 July of the next financial year).

Examples of when re-notification is not required
  • Change to an existing in-house test or test procedure that has previously been notified to us and does not require addition to the laboratory's existing NATA test list.
  • Manufacture of an existing in-house IVD has ceased. It is expected that this information would be updated in the next notification for the introduction of any new in-house IVDs.
  • Re-notification is not required if your laboratory has not introduced any new Class 1-3 in-house IVDs since your previous notification.
How to identify your Class 1-3 in-house IVDs in a single notification

In the electronic notification form you will be asked to select from predetermined broad categories that cover the types of Class 1-3 in-house IVDs in use in your laboratory.

Information to be attached to your notification

To further identify the Class 1-3 in-house IVDs you must attach a copy of the laboratory's in-house IVD test list e.g., your NATA test list (also provided to NATA for accreditation purposes) or an alternative in-house IVD test list will suffice. This should identify the individual tests, or test procedures, that are in-house IVDs.

Examples of in-house tests and procedures which could be found on a test list include:

  • multiple in-house IVDs that form part of or are used for the same test procedure (e.g., identified on the NATA test list as in-house culture media, in-house stains for general histology)
  • a single in-house test to detect a specific marker, analyte or pathogen (e.g., an in-house IVD to detect meningococcal disease)
  • a single in-house test to detect multiple specific markers, analytes or pathogens (e.g., a multiplex PCR for respiratory pathogens)
  • an in-house test procedure that incorporates a combination of individual markers, analytes or pathogens using the same testing platform or technology, and which are interpreted together in order to determine a specific condition (e.g., an in-house test to determine haematological malignancy using a panel of CD markers used in flow cytometry)

If you are unable to identify an appropriate category in the electronic notification form for your in-house IVD, please contact us for assistance at: devices@tga.gov.au

Submitting your notification

To submit a notification, the laboratory or an authorised person acting on behalf of the laboratory, must be a TGA 'client'.

Information on how to become a client, and gain access to TGA Business Services (TBS), is available at TGA Business services: getting started with the TGA.

User guidance for submission of the Laboratory's notification

Two user guidance documents to assist with the submission of the initial notification, as well as the process to re-notification process through updating the existing notification are available at Class 1-3 in-house IVDs: using the online application form and Updating an existing Class 1-3 in-house IVD notification.

Notification fees

Current notification fees are available in the TGA summary of Fees & Charges.

  • A notification fee applies to the initial notification, and to any subsequent re-notifications, and only one fee is charged per notification.

All Class 1-3 in-house IVDs manufactured by a laboratory (or a laboratory network) can be entered in the in-house IVD database in a single notification.

What happens once the notification is submitted
  • Once submitted (and the notification fee processed), the laboratory's details will be entered in the Class 1-3 in-house IVD notification database.
  • We will then send the laboratory an email advising them of the notification, and they will be able to view* their notification via their TBS account.
  • As outlined in the user guidance for Class 1-3 in-house IVDs: Using the online application form, a staff member would have been nominated as the Administrator for the organisation's account. If the person with Administrator rights has moved on, the laboratory will need to nominate a new representative by completing the Updating organisation administrator form and sending it through to ebs@health.gov.au.

*The Class 1-3 in-house IVD notification database is not publically viewable.

Class 4 in-house IVDs

Laboratories that manufacture Class 4 in-house IVDs must:

  • include them in the ARTG
  • comply with the conformity assessment procedures in Part 1 or Part 6B, Schedule 3, of the MD Regulations.

To do this, laboratories have a choice of two (2) pathways:

  1. Obtaining TGA conformity assessment certificates prior to applying for inclusion of their Class 4 in-house IVDs in the ARTG;
  2. or
  3. Using their existing NATA accreditation to ISO 15189, or their TGA Manufacturing licence, to apply directly for inclusion of their Class 4 in-house IVD in the ARTG.

TGA conformity assessment

Manufacturers of commercially supplied Class 4 IVDs are required to undergo TGA conformity assessment, and the manufacturer must apply for (and obtain) a TGA conformity assessment certificate before they can apply for ARTG inclusion.

This pathway is also applicable to the manufacturers of Class 4 in-house IVDs that:

  • don't currently hold valid NATA accreditation or a TGA issued licence to manufacture therapeutic goods, and
  • don't intend to obtain either of these in the future.

For this procedure, the laboratory will need to apply to us for a:

  • quality management system (QMS) certificate for the laboratory
  • design examination (DE) certificate for each Class 4 in-house IVD.
Assessment process
  • We will conduct an assessment for compliance with ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes. This details the requirements for a quality management system for the design and manufacture of medical devices.
  • Note: This process may also involve an on-site inspection.
  • As part of conformity assessment, we will also assess the technical documentation (i.e., analytical and clinical performance data) for the Class 4 in-house IVD to assess compliance with the essential principles for safety and performance.
  • If successful, we will issue the laboratory with a TGA Conformity Assessment QMS certificate and a DE Certificate for the Class 4 in-house IVD.

Once issued, the laboratory can then apply for inclusion of the Class 4 in-house IVD in the ARTG.

Applications for a TGA conformity assessment certificate for transitioning Class 4 in-house IVDs must be submitted to us by 1 July 2016.

Laboratories are encouraged to contact us on 1800 141 144 to arrange a pre-assessment meeting with the IVD Conformity Assessment team prior to submitting the conformity assessment certificate application.

Further information

For further information on TGA conformity assessment, see:

Using existing NATA accreditation to ISO 15189 or TGA Manufacturing licence

In this pathway, a laboratory can apply directly to include their Class 4 in-house IVD in the ARTG (i.e. without needing a TGA conformity assessment certificate) if they either:

Mandatory application audit

The application will be subject to a mandatory application audit, where we will assess the analytical and clinical evidence for the Class 4 in-house IVD to determine compliance with the relevant Essential Principles prior to ARTG inclusion.

For a Class 4 in-house IVD based on the modification of a commercially supplied Class 4 IVD already included in the ARTG, only the changes made to the commercially supplied IVD will be assessed.

Laboratories may also be required to provide evidence that they have appropriate procedures in place that allow them to monitor the on-going performance of the device and report any adverse events or problems associated with its use (see Post market responsibilities).

Further information

For more information on including Class 4 in-house IVDs in the ARTG, please see:

Fees for Class 4 In-house IVDs

Current fees are available in the TGA summary of Fees & Charges, and the total fees payable will vary depending on the chosen pathway.

The assessment fees reflect the maximum payment if the full fees were applied. In the majority of circumstances, a full assessment would not be required, and the fees could be reduced.

For example, if a laboratory has developed a Class 4 in-house IVD by modifying a commercially supplied Class 4 IVD (that has been previously assessed by us), then only the changes made to the commercially supplied product would need to be assessed and the assessment fees could be reduced.

TGA conformity assessment

If a laboratory chooses to obtain TGA conformity assessment certificates prior to applying for inclusion in the ARTG, then the following fees will apply:

  • Application fee for TGA conformity assessment certificate
  • A full quality management system inspection fee* (fee for evaluation of the QMS)
  • Additional fees may apply if an on-site inspection is required.
  • A design examination fee for each Class 4 in-house IVD (fee for evaluation of the technical documentation)
  • Application fee for inclusion in the ARTG
Using existing NATA accreditation to ISO 15189 or TGA manufacturing licence

If a laboratory chooses to apply directly for inclusion in the ARTG based on already having NATA accreditation to ISO 15189 or a TGA issued Manufacturing licence, then the following fees will apply:

  • Application fee for inclusion in the ARTG
  • Application audit assessment fee for Class 4 in-house IVDs (fee for evaluation of the technical documentation)

Footnotes

  1. Australian standard AS ISO 15189-2013 is identical to, and has been reproduced from, ISO 15189-2012.
  2. Australian standard AS ISO 17025-2005 is identical to, and has been reproduced from, ISO/IEC 17025-2005.

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