Re: TGA Hard surface disinfectants and changes to the registration and listing of disinfectants and sterilants

[Glenys Harrington]

Dear All,

Further to my earlier posting on TGA changes to the registration and listing
of hard surface disinfectants I would like to clarify that there are no
changes to the regulatory requirements for Class IIb accessories to medical
devices”

All disinfectants and sterilants intended by the manufacturer to be used to
disinfect medical devices are regulated in Australia as Class IIb
accessories to medical devices and the guidance set out in
https://www.tga.gov.au/regulation-disinfectants-and-sterilants is still
appropriate.

See extract below from the TGA web page:

“Disinfection or sterilisation of medical devices

Disinfection or sterilisation of medical devices is undertaken to prevent
the transmission of communicable diseases between the patient and other
patients or the user.

All disinfectants and sterilants intended by the manufacturer to be used to
disinfect medical devices are regulated in Australia as Class IIb
accessories to medical devices. In Europe, some of these products are
classified as Class IIa medical devices, and others are classified as Class
IIb medical devices, depending on the type of device they are intended to
disinfect.

Sponsors who wish to import these disinfectants and sterilants for use on
medical devices need to ensure that the Australian regulatory requirements
for Class IIb medical devices have been met by the manufacturer. Assessments
performed for Europe for the purposes of affixing the CE Mark may not be
sufficient for inclusion in the ARTG as a Class IIb medical device.

Compliance with essential principles

As accessories to medical devices, and disinfectants for a medical device
must comply with the essential principles for quality, safety and
performance.

Manufacturers must generate documentary evidence (a technical file) of
compliance with the essential principles that are relevant to their
disinfectant for a medical device. This documentation and evidence of its
assessment (if necessary) must be available to an Australian sponsor before
they can make an application for inclusion of the medical device in the
ARTG.

More information is available in the
Australian Regulatory Guidelines for Medical Devices
(ARGMD).

Conformity assessment procedures to be followed

As disinfectants for medical devices are classified as Class IIb medical
devices in Australia, any one of the following conformity assessment
procedures (see Schedule 3 of the
Therapeutic Goods
(Medical Devices) Regulations 2002) can be followed:

. Part 1 Full quality assurance procedures (other than clause 1.6)

. Part 2 Type examination and Part 3 Verification procedures

. Part 2 Type examination and Part 4 Production quality assurance
procedures

. Part 2 Type examination and Part 5 Product quality assurance
procedures.

For specific information on the requirements of each procedure, refer to the
Australian Regulatory Guidelines for Medical Devices
(ARGMD)”.

Regards

Glenys

Glenys Harrington

Infection Control Consultancy (ICC)

P.O. Box 6385

Melbourne

Australia, 3004

M: +61 404816434

E: infexion@ozemail.com.au

listing of disinfectants ans sterilants

Dear All,

For those who may not be aware the TGA has advised that the way hard surface
disinfectants are regulated has changed.

“Hard surface disinfectants have recently been down-regulated as a result of
the reform activities endorsed by Government from the Future Regulation of
Low Risk Products Review. This included:

. Downregulating Registered disinfectants entries on the Australian
Register of Therapeutic Goods to become Listed entries, and Listed
disinfectants are now exempt, and

. Pre-market review of listed disinfectants will only be conducted
on new ingredients (that are active) and/or new specific claims”.

Further information can be found at the following TGA web page links:

https://www.tga.gov.au/disinfectants-sterilants

https://www.tga.gov.au/consultation/consultation-review-therapeutic-goods-or
der-54-standards-disinfectants-and-associated-guidance

https://www.tga.gov.au/disinfectants-sterilants-regulation-basics

regards

Glenys

Glenys Harrington

Infection Control Consultancy (ICC)

P.O. Box 6385

Melbourne

Australia, 3004

M: +61 404816434

E: infexion@ozemail.com.au

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