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US FDA Plans to Adopt ISO13485 As Its Medical Device Regulations

The US Food and Drug Administration (FDA) announced that it plans to use the ISO13485 standard as the basis for its quality system legislation. If the FDA replaces its existing quality system regulations with the ISO13485 standard, it further enhances the recognition of the standard and has become one of the basic standards of the global medical system.

ISO13485 Chinese is called “Medical Device Quality Management System for Regulatory Requirements” Since medical devices are special products for dying, preventing and curing diseases, it is obviously not enough to standardize only the general requirements of ISO9000. For this reason, the ISO organization has released ISO13485: The 1996 version of the standard (YY/T0287 and YY/T0288) has set special requirements for the quality management system of medical device manufacturers, which has played a very good role in promoting the quality of medical devices.

As of today, the latest version of ISO13485 is ISO13485:2016, and its standard name and content have changed from previous versions.