FDA Registered Facilities

Our Xiamen, China factory exclusively serves the medical device industry and is the only such electronics contract manufacturer in China to have passed an FDA audit with 0 non conformities in the last 10 years.

We Cut Costs — Not Corners

We built our first ISO Quality System in 1998 and were certified as meeting ISO 9002 standards in 1999. In 2005, we became TUV Certified having met ISO 13485 standards and became FDA Registered. We are currently UL certified to ISO-13485:2016 standards and our quality system is QSR compliant and fully adheres to the 21 CFR Part 820 regulations. We are rigorously audited by leading global medical device companies on a routine basis.

FDA Registered

Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities registered through 2020.

ISO Certificate 2021

UL Certified

Sanbor Medical is  UL Certified to ISO-13485:2016 standards through October 2021.

View UL Certificate

#of FDA Inspected China Facilities 2019-ver2

FDA Field Inspected

Of the 1302 FDA CDRH inspected facilities in China from 1/1/2009-12/31/2019

  • 259 received NAI (no action indicated) results in Compliance: Devices
  • 11 of them were Electronics Contract Manufacturers
  •  Sanbor Medical was the only Electronics Contract Manufacturer that exclusively serves the medical industry.

Smarter Manufacturing Starts Here.

Connect with our team to learn how a Sanbor Medical partnership is the future of medical device contract manufacturing.

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