Network Safety and Wireless Compliance
As wireless technologies (Wifi, Bluetooth, cloud storage) become common in everyday life, many medical products are equipped with these technologies in order to enable remote communication between physicians and patients, allow remote control of device functions or data access, and for transmissions with cloud storage. It is more and more common to see products that can transmit patient data using WIFI, cellular network, and Bluetooth technologies. Nearly all such transmissions utilize the existing public wireless network.
These technologies expose medical products to issues such as patient privacy and cyber security. US FDA issued guidance on “Post Market Management of Cybersecurity in Medical Devices” at the end of 2016. China CFDA immediately followed suite with the release of its own “Guidance on Technical Evaluation of Network Safety in Medical Device”, requiring Class II and III product registration submission dossiers to include technical information to ensure risk analyses and methods for network safety. This guidance will be implemented on January 1, 2018.
Because products with wireless technology are more likely to use public networks to get access the world wide web, these products should also be in compliance with relevant regulations and requirements administered by the Ministry of Industry and Information Technology (MIIT). Wireless products entering the Chinese market require the mandatory certification: SRRC as well as NAL certifications.
State Radio Regulatory Commission -SRRC
SRRC is the certification required for all types of products (i.e. including medical devices) if they have any radio transmitter function. Each model of the transmission module needs to be approved through testing, submission, and review.
SRRC Certification Process
Network Access License -NAL
NAL certification is issued by MIIT for devices that need to access the public telecom network, such as cell phones, modems, telecom communication terminals, ethernet switches, and more. SRRC certification is required before applying for NAL license.
Whitney Consulting’s experts in the U.S. and China will work with you to ensures that your wireless product utilizes the right application, the right testing process, and moves through the certification process in a timely manner. We understand the regulations and technical requirements necessary to minimize the risk of test failure and rejection, and we stay updated on ever-changing regulations and requirements.