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Nortech Systems Suzhou Facility Certified to Produce Class II Medical Devices for Asia Market
October 5, 2023 | BUSINESS WIREEstimated reading time: 2 minutes
Nortech Systems Incorporated, a leading provider of engineering and manufacturing solutions for complex electromedical and electromechanical products, is proud to announce that its Suzhou, China facility has been certified by the National Medical Products Administration (NMPA, formerly known as CFDA) to produce Class II Medical Devices for customers in Asia. This certification marks a major milestone for Nortech Systems and its customers in the region.
“NMPA certification is a major step forward for Nortech Systems and our customers in the region,” said Nortech Systems CEO, Jay D. Miller. “This certification is a testament to the hard work and dedication of our team in Suzhou and will enable us to better serve our customers in the Chinese and Asia markets. We are excited to be able to offer our customers in China and the rest of Asia the same high-quality products and services that we offer our customers in other parts of the world,” said Miller.
The certification process was rigorous and included a comprehensive review of Nortech Systems’ quality management system, supply chain management, manufacturing processes, and product design. The certification also ensures that Nortech Systems’ products meet the highest standards of safety and efficacy.
The certification from the NMPA allows Nortech Systems to produce Class II Medical Devices for customers in China and Asia. The company has been a leading producer of Class II Medical Devices for the United States market in its FDA-registered facility located in Milaca, Minnesota. Class II Medical Devices are products that are intended to be used for medical purposes and are subject to more stringent regulations than other products.
Nortech Systems Suzhou facility is a state-of-the-art facility that is equipped with the latest technology and equipment. The facility is ISO 13485 certified and has a team of highly trained and experienced engineers and technicians.
“We are committed to providing our customers with the highest quality products and services,” said Nortech Systems Vice President of Operations for Asia Pacific, Feng Cao. “This certification from the NMPA is a testament to our commitment. There are presently very few companies in Suzhou that have been able to meet the rigorous requirements to achieve this certification.”
Nortech Systems is a leading provider of design, engineering, and manufacturing services for the medical, industrial, and aerospace markets. The company has a global presence with facilities in the United States, Mexico, and China.
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