Chinese Manufacturing of Medical Devices Meet FDA Quality Standards

Almost anything can be the product of Chinese manufacturing in the 21st century. Medical, surgical and laboratory equipment in America is increasingly the result of offshore manufacturing in China. Custom Chinese manufacturing of medical devices is becoming increasingly sought after.

Chinese manufacturing has acquired a name and reputation for making equipment for the healthcare sector that is without par; and for good reason. In 2009, new healthcare reforms were set up to revolutionize China’s primary healthcare industry. Because of these reforms, China urgently required international quality surgical systems, remote diagnostic technology and excellent imaging systems and it got them initially by importing almost 64% of its essential medical equipment.

The Chinese manufacturing industry had realized by 2010, however, the need for an internal production system for custom manufacturing of medical devices. Quickly, medical device manufacturing in China began to improve their own systems. Now, in 2013 as the Chinese manufacturing of medical devices is steadily increasing in quality as well as quantity, China is expected to have the third largest custom manufacturing of medical devices industry in the world by 2020 due to the rapid advances in the field of Chinese manufacturing of medical devices.

Chinese manufacturing firms quickly realized that manufacturing and exporting medical equipment successfully was only possible if they met international FDA-standards for quality and medical accuracy. As a result, the China Association for Medical Devices Industry set up strict standards for internal manufacturing of medical grade devices and custom manufacturing of medical devices for special clients. The basic device development pathway was also streamlined and modified to meet International Food and Drug Administration standards and this led to an immediate change in product development, planning and execution.

All Chinese manufacturing companies involved with the production of medical devices hired their own design teams for custom manufacturing of medical devices. These teams actively researched unmet needs in the medical market or consulted with international clients to create urgently required standards.

The Chinese expansion, improvement and success of the custom manufacturing of medical devices­­­­­­ has drastically increased the market share as well as the demand; and, indeed, the satisfaction of customers, doctors and patients.

ITI Manufacturing facilitates and oversees the Chinese manufacturing of medical devices that meet FDA quality standards.

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