NEWS on implant administration
Clinical Evaluation Reports under the EU MDR
Understanding Clinical Evaluation Reports under the EU MDR D Egbosimba Every medical device sold into Europe, new or existing, and irrespective of specification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. The manufacturer also needs to demonstrate that the device achieves its intended purpose...
China Regulation of Medical Devices
Global Impact: China's Regulations On The Supervision And Administration Of Medical Devices Yin A, Guo T, Rong M, Yang L, Smith R As China’s National Medical Products Administration (NMPA) moves closer to finalizing its 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices, medical device...
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