San Jose, Calif. – October 23, 2012 - MIBA Medical Inc., a medical aesthetics company, today announced the licensing by the State of California Food and Drug Branch (FDB) to manufacture Class 1, Class 2 and Class 3 medical devices. The FDB, which partners with the Food and Drug Administration (FDA), has authorized MIBA to operate under the rigorous quality guidelines of California's Device Manufacturing Licensing laws.
Prior to issuing the license, the FDB inspected the San Jose manufacturing facility on October 2, 2012. MIBA demonstrated compliance with all applicable state laws including the federal Good Manufacturing Practice (GMP), and the Quality System Regulations (QSR). Manufacturers must renew their license annually, and the FDB conducts periodic renewal inspections.
"I am extremely pleased that MIBA Medical Inc. has received the FDB Medical Device Manufacturing License from the State of California." said Dr. Phi Nguyen, MIBA's Founder & CEO. ”"The quality standards achieved through this new licensing, coupled with our existing quality management system, provides us with a good base for entering the regulatory approval phase from the FDA"
About MIBA Medical Inc.
MIBA Medical Inc. is a medical aesthetics company focused on developing and commercializing products that are used by physicians to enhance a patient's appearance. For more information, please visit http://www.mibamedical.com.