Today, Phillips-Medisize announced their Suzhou, China facility has registered with the China Food and Drug Administration (CFDA). 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. He continued, “Providing the highest level of customer satisfaction by deploying complementary quality systems allows us to provide improved product performance and effectiveness for our customers.”
In July, Phillips-Medisize announced that it had entered into a definitive agreement with the Adval Tech Group to purchasethe plant in Suzhou from Adval Tech Medical (Suzhou) Co. Ltd.