Phillips-Medisize China Facility Registers with CFDA and Receives ISO 13485 Certification
Published: November 21st, 2013
Phillips-Medisize announced their Suzhou, China facility has registered with the China Food and Drug Administration (CFDA), and the facility has also received ISO 13485 certification, with DEKRA being the notified body.
These certifications, along with a medical device manufacturing license, will enable the facility to begin production of a finished injection device in the first half of 2014 for its OEM customer and allow Phillips-Medisize to be a resource in supporting customer product registration with the CFDA in the future.
The Phillips-Medisize Mexico facility also received ISO 13485 certification, with DEKRA being the notified body.
“These certifications uphold our commitment to providing a robust quality system and allow us to immediately support our global customers,” said Matt Jennings, President and CEO of Phillips-Medisize Corporation. “Providing the highest level of customer satisfaction by deploying complementary quality systems allows us to provide improved product performance and effectiveness for our customers.”
Phillips-Medisize Corp. is a leading global outsource provider of design and manufacturing services to the medical device and diagnostics, drug delivery, and commercial markets, with annual sales of over $500 million. Of total revenue, 75% comes from drug delivery, and medical device and diagnostic products such as disposable insulin pens, glucose meters, specialty inhalation drug delivery devices, single use surgical devices and consumable diagnostic components, the company said in a press release.