Month: November 2017

On October 31, 2017, the China Food and Drug Administration (CFDA) issued the “Amendments to the Regulations on the Supervision and Administration of Medical Devices” Exposure Draft which aims to strengthen medical device technology reviews and approval systems. This draft guidance also further encourages medical technology innovation in light of the original guidance on “Opinions … Continued

Medical device products throughout the globe are characteristically classified by their specific risk level or category. This is no different in Japan, the world’s third largest medical device marketplace; however, there are important and very different considerations for manufacturers of Class II and III products in this territory than in any other part of the … Continued