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Frequently Asked Questions
Regulatory requirements can be confusing. The answers to these FAQ’s will
help you understand what action needs to be taken to obtain approval for your
product(s).
How do I know if my product is a medical device?
What Australian legislation applies to medical devices?
Who is responsible for the Australian legislation?
Does the same Australian legislation apply to In Vitro Diagnostics (IVD) products?
What does the Australian regulatory system consist of?
How are medical devices classified?
What is the Essential Principles Checklist?
What is Clinical Evidence?
Other than Australian approval what certifications can the TGA offer?
If I would like to supply the Australian market with a product that is already CE Marked, can I utilise this certification?
What is the CE Mark?
What countries require the CE mark?
What are the Directives?
What is the procedure for CE marking?
What is a Notified Body?
Why do I need the CE Mark?
How do I know if my product is a medical device?
A medical device is (reference- Section 41BD of the Therapeutic Goods Act 1989):
- 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:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
- investigation, replacement or modification of the anatomy or of a physiological process;
- 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
- an accessory to such an instrument, apparatus, appliance, material or other article.
What Australian legislation applies to medical devices?
The Therapeutic Goods (Medical Devices) Regulations 2002 applies to all medical devices. Copies of the legislation can be obtained from Government Info Shops or from Internet web sites, such as the Attorney General Department’s law resource at http://scaleplus.law.gov.au.
Who is responsible for the Australian legislation?
The Therapeutic Goods Administration (TGA), a Division of the Commonwealth Department of Health and Ageing, is responsible for administering the legislation. The Office of Device, Blood and Tissues (ODBT) is the department within the TGA that is responsible for regulating medical devices.
Does the same Australian legislation apply to In Vitro Diagnostics (IVD) products?
From July 2010 in-vitro diagnostic (IVD) device companies will be subjected to greater scrutiny by Australian regulator, the Therapeutic Goods Administration (TGA). The new rules bring IVDs in line with medical devices by requiring standard technical documentation (STED) and in some cases, a full quality system. Please refer to http://www.kdas.com.au/IVD for more information.
What does the Australian regulatory system consist of?
- A device classification scheme based on different levels of risk for each class
- 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 compliance with the essential principles can be met
- 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.
How are medical devices classified?
Classification is based on the manufacturer’s intended use, level of risk and degree of invasiveness to the human body. Correct classification is the responsibility of the manufacturer.
What is the Essential Principles Checklist?
This is a checklist that provides details on:
- 6 general requirements: Major safety and performance requirements that apply to all medical devices.
- 6 particular requirements: These only apply to certain medical devices
- Information to be provided with the medical device (instructions for use, labels)
- Clinical evidence
What is 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.
Other than Australian approval what certifications can the TGA offer?
Australian manufacturers may also gain CE mark certification utilising the Mutual Recognition Agreement (MRA) with the Therapeutic Goods Administration (TGA). Plans are also in place to offer Canadian approval in the future.
If I would like to supply the Australian market with a product that is already CE Marked, can I utilise this certification?
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. Please contact us for specific details on this option.
What is the CE Mark?
The CE Mark is affixed to products that meet the safety standards that apply to all countries of the European Union (EU). Products that have the CE Mark 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.
What countries require the CE mark?
The affixing of the CE Mark is required on designated products exported to European Economic Area (EEA). What are the Directives?
The Directives that are most relevant to medical device manufacturers are the Medical Devices 93/42/EEC 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.
A full list of the Directives and copies can be downloaded from:
http://www.newapproach.org
What is the procedure for CE marking?
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 a Technical File, implementation of quality management systems based on ISO 13485 and Notified Body assessment, to enable CE marking certification. Lower classifications only require a Technical File to enable CE marking certification.
A Notified Body is a company that holds the authority to assess and approve CE mark applications. The Notified Body performs assessment tasks to enable CE Marking of the product.
Australian manufacturers may also gain CE mark certification utilising the Mutual Recognition Agreement (MRA) with the Therapeutic Goods Administration (TGA).
One of the most important aspects of obtaining the CE Mark is the compilation of a Technical File.
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 EU. The CE Mark must have a height of at least 5.0mm.
What is a Notified Body?
A Notified Body holds the authority to assess and approve CE mark 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.
Why do I need the CE Mark?
Products which do not have the CE Mark 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 market without complying with the appropriate EN standards, can be held personally liable for damages or injury, as well as being prosecuted.
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