Medical devices – does your medical device connect to a telecommunications network? Does your device use Bluetooth or Wi-Fi? Read more.
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.
- Telecommunications (Labelling Notice for Customer Equipment and Customer Cabling) Instrument 2015 (Telecommunications labelling notice)
- Radiocommunications (Compliance Labelling – Devices) Notice 2014 (radio labelling notice)
- Radiocommunications (Compliance Labelling – Electromagnetic Radiation) Notice 2014 (EME labelling notice)
- Radiocommunications Labelling (Electromagnetic Compatibility) Notice 2017 (EMC labelling notice)
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.