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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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Conditions on certificates

Under the Therapeutic Goods Act 1989, three types of conditions may be imposed when a TGA Conformity Assessment Certificate is issued. They are:

Automatic conditions on a TGA Conformity Assessment Certificate

Under section 41EJ of the Act, there are four types of conditions that will be imposed automatically when a TGA Conformity Assessment Certificate is issued:

1. Entry and inspection powers

The manufacturer will allow an authorised person to:

  • enter premises, including premises outside Australia, at which the manufacturer, or any other person deals with the medical devices covered by the certificate
  • inspect those premises and the medical devices, and to take samples of the devices
  • carry out tests or require tests to be carried out on the devices, on the premises
  • to see and copy any requested documents relating to the medical device or the manufacturer's quality management system.

2. Review requirements

The manufacturer will cooperate with any review by the TGA of matters relating to the certificate, including:

  • the application of quality management systems
  • compliance with the Essential Principles
  • any other conformity assessment procedures specified in the regulations.

3. Notification of substantial changes

The manufacturer of a medical device will notify the TGA, in writing, of any plan for substantial changes to the:

  • quality management systems
  • product range
  • product design.

4. Payment of fees

Any prescribed fees for a review of a TGA Conformity Assessment Certificate will be paid when they are due.

Conditions imposed when a certificate is issued

When a TGA Conformity Assessment Certificate is issued, in addition to the automatic conditions outlined above, other conditions may be imposed under section 41EK of the Act. They are conditions on:

  • one or more of the devices covered by the certificate
  • the manufacturer’s quality management system.

Conditions imposed after the certificate has been issued

After a TGA Conformity Assessment Certificate is issued, the TGA may vary, remove or impose new conditions on the certificate under section 41EL of the Act. This action can result from an initiative of the TGA or at the request of the applicant for the certificate. The TGA will provide written notice of the proposed change to the manufacturer.

The new conditions may relate to:

  • one or more of the devices covered by the certificate
  • the manufacturer's quality management system
  • varying or removing existing conditions.

The new conditions will take effect immediately if action is required to prevent the imminent risk of death or serious injury. In all other cases, they will take effect 20 working days after the notice has been provided.

A decision by the Secretary or a delegate to impose a condition on a TGA Conformity Assessment Certificate after the certificate has been issued is an appealable decision as it would be an 'initial decision' under section 60(1)(e) of the Act.

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