International registration of medical devices with wireless functionality
The advances in wireless technologies is offering medical device manufacturers enormous potential for innovation. However, in the wake of these new technologies, the medical device industry is also facing new and additional requirements. In addition to the relevant medical device directives, the radio-controlled devices also need to meet the requirements for radio equipment in the individual jurisdictions, which include the R&TTED or RED Directives in the EU, the FCC/ISED requirements in the USA and Canada, the MIC requirements in Japan, and the ANATEL requirements in Brazil.
TÜV SÜD’s team of international experts is highly familiar with these requirements and can provide valuable support. TÜV SÜD’s new testing laboratory in Straubing also offers many possibilities for testing the function and safety of wireless products. Interested in learning more about the international registration of wireless medical devices? Please contact our specialists Thomas Ring or our customer service.
Points to consider right from the start for wireless medical devices to ensure successful registration:
Are you aware of your national laws and requirements, e.g. test standards and permitted frequencies at an early stage?
Are you familiar with the administrative regulations of the registration process, in particular regulations relating to packaging, equipment labelling, or the need for a local authorized representative in the relevant country to act as registration holder?
Do you know which authority is responsible for the registration of radio Equipment?
Are the purchased radio components used in your medical device registered for operation in the country in question, and may you use this Registration?
Is the Technical Documentation, including that of the purchased radio modules, complete?