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11 May

Medical devices – does your medical device connect to a telecommunications network? Does your device use Bluetooth or Wi-Fi? Read more.

Medical devices

Does your medical device connect to a telecommunications network?

Does your device have radio transmitters (such as Bluetooth or Wi-Fi)?

This information may be of interest to you.

More requirements than medical safety and EMC

In Australia, in addition to electromedical safety and EMC requirements, there are regulations that apply to equipment that can connect to a telecommunications network, equipment that incorporates one or more radiocommunications transmitters, and requirements to prevent equipment from causing radio interference. Many of these requirements may also apply to medical devices depending on the features of your device.

The Australian Communications and Media Authority (ACMA) is the Australian Government regulator for telecommunications and radiocommunications. The ACMA has a range of equipment regulations that may apply.

The ACMA’s labelling notices place obligations on the importer (in Australia) of the equipment into Australia, or the manufacturer (in Australia) of the equipment that must be met before the equipment is able to be supplied in Australia.

The obligations in the labelling notices include the requirement to ensure the equipment complies with applicable standards, keeping records that demonstrate compliance, to register on the national database as a supplier and to label the equipment to show it complies.

There are four labelling notices by the ACMA which have requirements for equipment. It is possible that all four labelling notices could apply to the same equipment.

The ACMA labelling notices will specify which standards your equipment must comply with.

But do these apply to medical devices?

If your medical device is required to comply with EMC requirements as part of regulation by the Therapeutic Goods Administration (TGA) then your device may be exempt from the EMC labelling notice.

However, there are no medical device exemptions in the other labelling notices. If you have Bluetooth or Wi-Fi, or another radio transmitter there may be requirements in the radio labelling notice and the EME labelling notice.

If your device can connect to a telecommunications network, such as 3G or 4G mobile networks, there may be requirements in the telecommunications labelling notice.

What can I do to get assistance?

Certification Body Australia can assist you with meeting your obligations.

Certification Body Australia (CBA) is an independent provider of product compliance services to manufacturers and distributors of electrical and electronic devices. Our specialist and highly experienced team will ensure your products conform with all applicable Australian regulatory requirements to not only minimize any risk of liability but assist your rapid time to market.

If you would like to discuss how CBA can assist you with your regulatory requirements, please contact Colin Payne (cpayneMA@outlook.com) or contact@certificationbody.com.au.

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31 Aug

Medical Device Regulatory Practices – An International Perspective, by Val Theisz

This book is intended to serve as a reference for professionals in the medical device industry, in particular those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated and the bar is raised constantly as patients and consumers expect the best quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success.
Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

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30 Jun
28 Feb

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