Regulations on Customized Medical Devices (Trial)

On July 4, the National Medical Products Administration and the National Health Commission issued the Regulations on the Supervision and Administration of Customized Medical Devices (Trial), which came into effect on January 1, 2020. Personalized medical devices refer to medical devices designed and manufactured according to the clinical needs of authorized medical personnel in medical institutions, which meet the individual requirements. They are divided into customized medical devices and patient-matched medical devices. The customized medical devices shall be put on record before going on the market. Manufacturing enterprises of customized medical devices and medical institutions shall jointly act as archivists.Read More →

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