For the first time, China on January 1 began regulating the use of customized medical devices, which are similar to already-approved devices, but custom-made to the specifications of a single patient based on prescribed needs. Until now, customized medical devices, often made to meet rare or special needs of a particular patient, had been excluded from regulation in China, leaving patients without recourse in the event of a malfunction.
In stipulating that customized medical devices must be filed with authorities, the government is providing key legal safeguards for both doctors and patients, improving safety. The use of customized devices has blossomed in recent years, as technologies such as 3D printing have made it possible to customize standardized medical devices to accommodate the varying anatomy of patients, including lesions and bone defects. The individualized tailored devices can improve the effectiveness of diagnosis and treatment.