Strategic Device Compliance Services Has Provided Training To China’s State Food and Drug Administration Test Centers

In July and August of 2004 and again in October of 2006, Strategic Device Compliance Services joined the Guangdong Medical Instruments Test Center (a division of China’s State Food And Drug Administration or SFDA) to provide training on the IEC 60601-1 Series of standards for over 250 individuals representing Chinese based manufacturers, SFDA Regulators and technical personnel from the Test Center. This seminar series offered in Guangzhou and Zhuhai China represented the beginning of long term cooperation between the SFDA and Strategic Device Compliance Services. This cooperative effort can provide support to Chinese Device Manufacturers in complying with Internationally recognized safety standards and also help open the Chinese Market to Device Manufacturers in the West. Projects currently being planned in cooperation with the Chinese SFDA and Chinese manufacturers include:

· Development  of new SFDA Test Facilities in China

· Introduce IEC 60601-1: 2005 to the Chinese Device Industry

· Establishing Strategic Partnerships between Western and Chinese manufacturers of medical devices.

· Establishing a fast track approvals process for Western manufacturers who want  to sell in China.

· And more opportunities….

 

By establishing our organization as a partner with the manufacturing industry and regulatory officials in China and throughout the Pacific Rim, Strategic Device Compliance Services can provide your organization a level of access only available to those with years of experience in these markets. Contact us today and allow the relationships we have developed in Asia open new opportunities for your business that will help your bottom line today and for years to come!

We also support Regulatory and Standards Compliance in other markets around the World...

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Some of the staff of The Guangdong Medical Instrument Test Center with Mr. Schmidt of Strategic Device Compliance Services

A few graduates of the training program co-sponsored by The Guangdong Medical Instrument Test Center and Strategic Device Compliance Services.  More on our training programs on Standards and Regulation...