Frequently Asked Questions

The definition of a medical device according to Section 41BD of the Australian Therapeutic Goods Act 1989 is given below:

a. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

i. diagnosis, prevention, monitoring, treatment or alleviation of disease;

ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

iii. investigation, replacement or modification of the anatomy or of a physiological process;

iiii. control of conception; and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

b. an accessory to such an instrument, apparatus, appliance, material or other article.

The definition of an IVD according to the Therapeutic Goods (Medical Device) Regulation 2002 as amended is given below:

a. a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with another diagnostic product for in vitro use; and

b. intended by the manufacturer to be used in vitro for the examination of a specimen derived from the human body, solely or principally for:

(i) giving information about a physiological or pathological state or a congenital abnormality; or

(ii) determining safety and compatibility with a potential recipient; or

(iii) monitoring therapeutic measures; and

c. not a product that is:

(i) intended for general laboratory use; and

(ii) not manufactured, sold or presented for use as an IVD medical device.

The Therapeutic Goods Administration (TGA), a Division of the Commonwealth Department of Health and Ageing, is responsible for administering the legislation. The Office of Devices, Blood and Tissues (ODBT) is the department within the TGA that is responsible for regulating IVDs and medical devices.

  • A risk based classification scheme using Class I, Class IIa, Class IIb, and Class III for medical devices, and Class I, Class II, Class III, and Class III for IVDs.
  • Essential Principles for the quality, safety and performance of the medical that must be complied with before the product can be supplied.
  • Options as to how to demonstrate compliance with the requirements
  • The use of recognised standards to meet requirements of the Essential Principles
  • A post market surveillance and adverse incident report system
  • Regulatory controls for the manufacturing processes of medical devices and IVDs, including Quality Management System requirements.
  • The Australian Register of Therapeutic Goods (ARTG).

Classification is based on the manufacturer’s intended use, level of risk, period of use, and degree of invasiveness to the human body. Correct classification is the responsibility of the manufacturer.

This is a checklist that provides details on:

  • General requirements: Major safety and performance requirements that apply to all medical devices and IVDs.
  • Particular requirements: These only apply to certain medical devices and IVDs.
  • Information to be provided with the medical device or IVDs (instructions for use, labels).
  • Clinical evidence

Clinical evidence is clinical data derived from a clinical investigation, clinical investigation program or literature. A critical evaluation, which is a critical appraisal of the medical device and clinical data, is also necessary. The critical evaluation must be completed by a competent clinical expert in a relevant field.

The TGA can issue CE Marking (utilising the Mutual Recognition Agreement (MRA)) and Health Canada certification (utilising the Memorandum of Understanding (MoU)) to Australian medical device manufacturers.

Yes, it is possible to gain Australian approval as a sponsor. This process is much simpler and less costly than the process that must be followed by manufacturers. KD&A can assist with this process. To complete this process, the CE Marking held must be to the Medical Device Directive 93/42/EEC as amended.

CE Marking is affixed to products that meet the safety standards that apply to all countries of the European Union (EU). Products that have CE Marking are able to move freely within the EU.

To be able to add this mark to their products, manufacturers must follow a set of procedures outlined in the relevant Directive for their product. Each Directive covers a range of products and specifies the essential safety requirements that products must satisfy before they may be sold anywhere in the EU.

CE Marking is required on designated products exported to European Union (EU).

The Directives that are most relevant to medical device manufacturers are the Medical Devices 93/42/EEC as amended and Medical Devices in Vitro Diagnostics 98/79/EC. Products can be covered by more than one Directive. Whether one or more Directive applies, manufacturers must ensure that their product meets the requirements set out in the Directive(s), together with the standards issued under the authority of the Directive.

The classification information contained in the Directive(s) provides details on the class level of each product and establishes the necessary requirements to enable CE Marking of the product/s.

Correct classification is critical. Certain classifications require technical documentation, implementation and maintenance of a Quality Management System based on ISO 13485 and Notified Body assessment, to enable CE Marking certification. Lower classifications only require technical documentation to enable CE Marking certification.

One of the most important aspects of obtaining CE Marking is the compilation of technical documentation.

The CE Mark must be affixed to the product, or if this is not possible, to its packaging. It must also be affixed to the accompanying documents by the manufacturer, or the authorized representative in the European Union (EU). The CE Mark must have a height of at least 5.0mm.

Products which do not have CE Marking and are not compliant with the Directives may be restricted, prohibited from sale, or forced to withdraw from the European market.

Manufacturers and authorised representatives, or anyone responsible for placing products on the European Union (EU) market without complying with the appropriate EN standards, can be held personally liable for damages or injury, as well as being prosecuted.

A Notified Body holds the authority to assess and complete CE Marking applications. They must be totally independent from the manufacturer. Notified Bodies perform unbiased testing and assessment tasks and certify that the manufacturer has taken steps to ensure compliance, they do not approve a product to be safe. Manufacturers and exporters may choose a notified body located in any EU member state. KD&A can recommend a Notified Body for your company.

Prices vary between Notified Bodies, product type and conformity assessment procedures. It is recommended that you obtain quotes from several notified bodies. Ensure that quotes determine the costs for ongoing certification and additional markets. For example; Canada, Asia, and New Zealand.