www.fdanews.com/articles/167290-oct-1-deadline-for-china-device-regulations-sends-shockwaves-through-industry
Oct. 1 Deadline for China Device Regulations Sends Shockwaves Through Industry
September 21, 2014
The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function.
International Medical Device Regulatory Monitor