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China’s CMDE Announces New Regulations on the Supervision and Administration of Customized Medical Devices for Clinical Trials

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  1. Customized medical devices (CMD) are devices that are designed and produced according to suitable provisions based upon the clinical needs of a specific patient group as determined by the physician. These devices are specifically catered for rare conditions. Personalized medical devices are expected to improve the diagnostic performance and treatment efficacy.
  2. Patient matching medical device (PMMD), are devices designed and produced for a particular patient by a medical device manufacturer through a proven process based on standard provisions for mass production of medical devices, in accordance with the clinical demands.