Medical devices; Medical equipment (ICS 11.040)

Draft of the Medical Device Product Items That Shall Accord Specification, Testing Method and Performance (1 page(s), in English; 2 page(s), in Chinese)

The Food and Drug Administration (FDA) is proposing to draft the ''Medical Device Product Items That Shall Accord Specification, Testing Method and Performance.'' The regulation is intended to develop a complete management mechanism for medical devices, to request the quality of medical devices and protect the safety and well-being of the public.