What is a personalized medical device?
Personalized medical devices refer to medical device manufacturers designed and manufactured to meet the individual needs of patients, and medical personnel licensed by medical institutions.
The proposed medical device. They are divided into custom medical devices and patient-matched medical devices. Guangxi Medical Supplies
Customized medical devices are produced by medical device manufacturers according to the clinical needs of medical institutions, and are used to treat rare and special injuries of designated people. Personalized medical devices that are expected to improve the role of diagnosis and treatment. Therefore, customized medical devices have the following characteristics: First, it is used for the diagnosis and treatment of rare and special wounds. The expected number of users is too low, the population sample is not enough to carry out clinical trials, the second is that the products already on the market in China are difficult to meet clinical needs, the third is proposed by clinicians, designed and produced to meet special clinical needs, and the fourth is for a specific patient, it is expected to improve the governance role.
Patient-matched medical devices refer to personalized medical devices provided by medical device manufacturers for designated patients according to medical needs, standard specifications, and verified and confirmed processes. The patient four-match medical device has the following characteristics: first, it is designed and produced on the basis of mass production of medical device products according to standard specifications, matching the personalized characteristics of patients, which can be regarded as a specific specification model of standardized products in essence; second, its design and production must be kept within the scope of verification and confirmation; third, it is used for patients who can carry out clinical research. Such as custom denture, rigid breathable contact lens for corneal shaping, orthopedic surgery guide plate, etc. Patient-matched medical devices shall be registered or filed in accordance with regulations, and the product specifications and models registered/filed shall be all possible production size ranges. Guangxi Medical Devices
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