In Australia, Devices are regulated by the TGA either under the Therapeutic Goods (Medical Devices) Regulations 2002 or the Therapeutic Goods Regulations 1990. Under the medical device regulations products are classified as MEDICAL DEVICES or IVD’s (IN VITRO DIAGNOSTIC Devices) and generally follow the same rules and classifications as medical devices in the EU.

Under the therapeutic goods regulations, products that are assessed by the TGA under the general umbrella of devices mainly include DISINFECTANTS – which are products for disinfection of surfaces or equipment or the general environment but are not for application to humans.

For Medical Devices there are three general classifications depending on risk, Class I, IIa/IIb; and Class III which represent the highest level of risk.Class I devices are further classified as Class I sterile (Class IS) or Class I measuring (Class IM).

IVD’s also have similar classifications of risk.

Application Process

For inclusion of a medical device onto the Australian Register of Therapeutic Goods (ARTG) there is an obligation on sponsors to ensure that they have the appropriate information available and that all of the regulations have been met.

This is where the expertise of Regulatory Concepts can assist. We review your documents, liaise with the manufacturer and ensure your files include the required documentation to support an application to the TGA. If questions are raised, we will work with your manufacturer to ensure the responses to the TGA are of the highest standard and in address all of the concerns raised. .

Conformity Assessment/Design Certification

Prior to a medical device application, determination of  the manufacturer’s quality certification is required. If they do not hold acceptable certification, then TGA conformity assessment may need to be considered, including a design certificate.

Regulatory Concepts can assist you with the requirements and process for both of these, if necessary including their renewal and or variations.

Maintenance

Maintenance activities we provide include, but are not limited to:-

  • updating/renewal of manufacturer’s evidence.
  • Updating/renewal of conformity and design certificates
  • safety reports and followup
  • updating MDOC’s and EP’s
  • review of labels, product information and advertising material
  • variations to existing entries

.

New Zealand

Medical Devices are not assessed by MEDSAFE, however they do need to be included on a database (WAND) via an online application.  This is similar to the online applications in Australia – so we can assist you to make sure that you have the correct information to include on the online database.

Medical devices in NZ still have to comply with all advertising rules which are again similar to Australian advertising rules. We can assist in reviewing your labels, instructions for use, promotional material to help you develop documentation that is equally acceptable in Australia and NZ and help you through the TAPS advertising assessment- see advertising.

If you have plans to enter the NZ market, we can assist with building those submissions. As with Australian products, we can manage the maintenance requirements of your NZ registrations. We can help plan your labels so that you can use the same label in both Austral and NZ.

Disinfectants – are products for disinfection of surfaces or equipment or the general environment but are not for application to humans. They are assessed by the devices section of the TGA. They can fall into 3 possible classifications – Registered, Listed, and exempt or they may be considered as excluded goods which means they are not regulated by the Therapeutic Goods legislation.

The classification of disinfectants is generally based on the intended purpose and the claims being made – There are several different legislative references that are relevant when considering the classification of disinfectants. Regulatory Concepts has the knowledge and experience to review your product and the available evidence and help determine what is the best classification for your product. We can review your product labelling, promotional material to ensure  they are consistent and within the advertising rules- see labelling & advertising.

We can also help you plan the development of your product if you wish to move to a higher classification.

Medical Devices & IVD’s

For Medical Devices there are three general classifications depending on risk, Class I, IIa/IIb; and Class III which represent the highest level of risk.Class I devices are further classified as Class I sterile (Class IS) or Class I measuring (Class IM).

IVD’s also have similar classifications of risk.

Application Process

For inclusion of a medical device onto the Australian Register of Therapeutic Goods (ARTG) there is an obligation on sponsors to ensure that they have the appropriate information available and that all of the regulations have been met.

This is where the expertise of Regulatory Concepts can assist. We review your documents, liaise with the manufacturer and ensure your files include the required documentation to support an application to the TGA. If questions are raised, we will work with your manufacturer to ensure the responses to the TGA are of the highest standard and in address all of the concerns raised. .

Conformity Assessment/Design Certification

Prior to a medical device application, determination of  the manufacturer’s quality certification is required. If they do not hold acceptable certification, then TGA conformity assessment may need to be considered, including a design certificate.

Regulatory Concepts can assist you with the requirements and process for both of these, if necessary including their renewal and or variations.

Maintenance

Maintenance activities we provide include, but are not limited to:-

  • updating/renewal of manufacturer’s evidence.
  • Updating/renewal of conformity and design certificates
  • safety reports and followup
  • updating MDOC’s and EP’s
  • review of labels, product information and advertising material
  • variations to existing entries

.

New Zealand

Medical Devices are not assessed by MEDSAFE, however they do need to be included on a database (WAND) via an online application.  This is similar to the online applications in Australia – so we can assist you to make sure that you have the correct information to include on the online database.

Medical devices in NZ still have to comply with all advertising rules which are again similar to Australian advertising rules. We can assist in reviewing your labels, instructions for use, promotional material to help you develop documentation that is equally acceptable in Australia and NZ and help you through the TAPS advertising assessment- see advertising.

If you have plans to enter the NZ market, we can assist with building those submissions. As with Australian products, we can manage the maintenance requirements of your NZ registrations. We can help plan your labels so that you can use the same label in both Austral and NZ.

Disinfectants

Disinfectants – are products for disinfection of surfaces or equipment or the general environment but are not for application to humans. They are assessed by the devices section of the TGA. They can fall into 3 possible classifications – Registered, Listed, and exempt or they may be considered as excluded goods which means they are not regulated by the Therapeutic Goods legislation.

The classification of disinfectants is generally based on the intended purpose and the claims being made – There are several different legislative references that are relevant when considering the classification of disinfectants. Regulatory Concepts has the knowledge and experience to review your product and the available evidence and help determine what is the best classification for your product. We can review your product labelling, promotional material to ensure  they are consistent and within the advertising rules- see labelling & advertising.

We can also help you plan the development of your product if you wish to move to a higher classification.

Regulatory Concepts

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