Telecommunication and radio certification for medical devices with Wi-Fi

Wireless technologies are also increasingly used in medical devices. For manufacturers, however, the enormous innovation potential also presents challenges in terms of national and international approval. Wireless communication makes medical devices smaller and their use more convenient, efficient and cost-saving. In addition to the respective, country-specific guidelines for medical devices, the respective national laws and test regulations of the telecommunications sector also apply to devices with radio modules. Similar to the EU-RED directive or the FCC requirements in the USA, the requirements of the Ministry of the Interior and Communications (MIC) must be fulfilled in Japan.

Since it is easier and means a shorter development time for the manufacturers of medical devices, they often use already tested and certified radio modules. When integrating these modules, however, the developer and quality manager must first familiarize himself with the new requirements for the installation and operation of a radio module. It is important to know the conformity and approval requirements of the respective regions or countries. Both the legal and the technical status of the module must be taken into account.

For the Japanese market and the approval there by the MIC, the radio products must be certified in a recognized laboratory accredited to ISO 17025. One of the challenges of certification is that many technical specifications are only available in the local language. It is therefore advisable for manufacturers to seek advice from a partner who has a location in Japan or is already familiar with national standards. Approval by the state authority MIC is mandatory for the marketability of the products in Japan. Upon issuance of the approval, the manufacturer is obliged to mark his product with a label that complies with the MIC requirements. Once issued, the MIC certification is valid for an unlimited period of time as long as the radio characteristics of the module or end-use device do not change.

If you need assistance with certifications of Wireless-equipment, medical devices or other products for the Japanese market or have any questions, you can contact us any time.

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