Manufacturing medical devices & IVDs

This section is for manufacturers of medical devices and IVDs. You should also see 'Manufacturing basics' which includes information for manufacturers of all types of therapeutic goods.

Manufacturers take full responsibility for the design and production of a medical device whether they make the device themselves or subcontract some of these activities. The name and address of the manufacturer always appears on the device label.

If you have an enquiry about medical devices that is not answered by this website, please see the contact details for medical devices enquiries.

Medical devices

• Custom made medical devices
  Manufacturing of custom made devices must, at a minimum, meet conformity assessment procedures regulated by the TGA.
• New format for TGA conformity assessment certificates
  In early 2011, the TGA Office of Devices Authorisation started issuing new electronic conformity assessment certificates to medical device manufacturers
• Systems or procedure packs: Declarations under Schedule 3 Part 7.5
  Clarifies a number of issues which could be of relevance to some companies assembling procedure packs for supply in Australia
• Manufacturing medical devices: where to start
  There are different regulatory requirements and processes that apply to medical device manufacturing activities

IVDs

• Acceptable evidence of good manufacturing practice (GMP) for IVDs
  Requirements for evidence of good manufacturing practice for all in vitro diagnostic devices (IVDs) that must be registered or listed on the ARTG prior to supply in Australia
• What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
  Depending on the classification of a device, there are a number of different conformity assessment procedures a manufacturer may use to demonstrate compliance with the Essential Principles

Standards & guidelines

• Guidance on licensing/certification inspections
  The TGA performs inspections of Australian manufacturers of therapeutic goods to ensure that they meet an acceptable standard of GMP or comply with QMS standards
• Guidelines for sterility testing of therapeutic goods
  Guidance for sterility testing of therapeutic drugs and devices supplied in Australia
• Manufacture of medical devices: Quality management
  As with all therapeutic goods, medical devices are expected to be of a high quality. Quality management systems are required to be in place.
• Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013
  Amendments to the EU-Australia MRA (Mutual Recognition Agreements) on conformity assessment to come into force on 1 January 2013