Today’s newsletter focuses on two Asian growth markets – China and South Korea. As we are your partner for the registration of medical devices throughout the world, we operate offices and testing laboratories in these and many other countries. Our local specialists help you overcome language and cultural barriers as well as bureaucratic hurdles. We expand our accreditations and recognitions wherever possible – most recently expanding our existing OSHA recognition as a NRTL for the USA and Canada.
And, of course, we also keep you informed about our domestic markets, reporting on the new European Directive on Radio Equipment and national IT security requirements. This brings us to Germany. There, the extremely strict national Data Protection Act defines very specific requirements that must be complied with by all market players seeking to place on the market medical devices intended to be incorporated into an IT network. Global or local, we keep an eye on important developments to ensure you are always up to date.
We hope you find our newsletter interesting and informative!
Dr. Peter Havel
Senior Vice President, Medical & Health Services Global
China: The changes brought about by the new regulation
The “Regulations for the Supervision and Administration of Medical Devices“ of March 7, 2014 in China have been in place for a little over one year. Since the end of May 2015 the CFDA has charged registration fees. Learn more about the key changes.
New Med-Info on IT security
Developers of medical devices designed to allow exchange of data with other devices need to monitor the regulatory and legal requirements applicable to the exchange of data and IT networks. TÜV SÜD has summarized the key information on this subject in a Med-Info.
South Korea: Changes in Medical Device Act
South Korea′s Ministry for Food and Drug Safety (MFDS) announced major changes in its medical device regulations that also, and primarily, concern the certification of Class I and II medical devices. What manufacturers should know.
Clinical Evaluation Report (CER) of implant
Within the Medical Device Directives the CER for an implant needs to include evidence- based information on the stability and lifetime of the implant in a human being. Read more
Radiofrequency medical devices
After 13 years, the European Directive on Radio and Telecommunications Terminal Equipment (R&TTE, 1999/5/EC) will be repealed in June 2016 and replaced by the new Radio Equipment Directive (RED, 2014/53/EU). More about the new requirements
NRTL marking for the USA and Canada
The Occupational Safety & Health Administration (OSHA) recognizes TÜV SÜD America as a Nationally Recognized Testing Laboratory (NRTL) for the testing and certification of medical devices according to the national deviations from the IEC 60601-1 standard in the USA and Canada. Read more