Wireless connectivity is becoming increasingly common in medical devices, with technologies such as Bluetooth, Wi-Fi, and RFID supporting a growing range of connected functions. However, integrating radio technology introduces an additional layer of regulatory complexity. Manufacturers must consider not only the requirements that apply to the medical device itself, but also the radio approval requirements in each intended market.
In this webinar, CSA Group experts will provide practical insights into the global radio approval landscape for medical devices and explain how radio approvals differ from medical device approvals. For the European market, the session will examine the requirements of the Radio Equipment Directive (RED) alongside those of the Medical Device Regulation (MDR), highlighting why both regulatory frameworks need to be considered for connected medical devices.
The webinar will also explore FCC and ISED approval pathways in the U.S. and Canada, with a particular focus on the certification and integration of radio modules. In addition, the speakers will discuss country-specific approval requirements and current regulatory developments in selected markets across Asia, Africa, and Latin America, providing an overview of how requirements and approval processes can vary between regions, and how RED or FCC test reports may be used to support approvals in some countries.
Key Learning Objectives:
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- Understand how radio approval requirements differ from medical device approval requirements.
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- Review key requirements under the RED alongside the MDR in Europe.
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- Learn about FCC and ISED approval pathways, including radio module integration.
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- Gain an overview of country-specific requirements and regulatory developments in selected markets, and learn how RED or FCC test reports may be used to support approvals in some countries.
Join the webinar to gain a clearer understanding of the key radio approval requirements and considerations involved in planning global market access for connected medical devices. Learn how radio approvals fit into the broader regulatory landscape and what manufacturers should consider when preparing to enter international markets. Register today.
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