Basic requirements for medical devices

2024-07-19

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The basic requirements of medical devices refer to the safety and performance requirements that medical devices must meet during their life cycle. These requirements ensure that medical devices are safe, effective and compliant. In the registration application materials, the relevant contents of the basic requirements must be set, such as the FDA's "Declaration of Conformity and Summary of Evidence" and the EU's "Basic Requirements List". For medical devices containing tissues, cells and other substances of animal origin, the tissues, cells and substances of animal origin shall comply with relevant regulations and provide ideal safety protection. In addition, medical devices containing human tissues, cells and other substances should be selected from appropriate sources and donors to reduce the risk of infection. The requirements for medical device registration application materials and the format of approval documents have been implemented since January 1, 2022.

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To: Hebei Fuda Goldwork Medical Equipment Co., Ltd.

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