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Japan Updates Standards for Device Connectors
Devices Regulatory Affairs
Japan’s Pharmaceuticals and Medical Devices Agency is revising standards for connectors of medical devices to prevent misconnections across different product areas.
The regulator said new standard products in each product area should be marketed in sequence and that new and old standard products will not connect with each other.
The standards will apply to neuroaxial applications, breathing systems, enteral applications, urethral and urinary applications and limb cuff inflation applications.