Medical Device Safety Section Licensing Programs
The Medical Device Safety Section Licensing Programs' mission is to provide an uncompromising standard of public health protection by assuring that medical devices produced and retailed for home use in California are safe and effective. We accomplish our mission through science-based investigations and specific legal authority, uniformity of enforcement, balanced with effective industry and consumer education by employing leading-edge technology. We also endeavor to achieve a partnership of trust with the industry and public sector through our commitment to fair business and regulatory practices.
Our vision is to be a globally recognized model for medical device safety program excellence that fosters industry growth and technological innovation, creates a fair and scientific-based regulatory environment that attracts responsible industry to California, and assures public health protection for all users of California-produced devices.
The Legislature established the Drug and Device Safety fund where all Medical Device License fees are deposited. A copy of the 2003 Drug, Medical Device and Home Medical Device Retailer License Fee Costs and Analysis can be found here.
The Medical Device Manufacturer Licensing Program and the Home Medical Device Retailer Licensing Program can be contacted at the medical device manufacturer or retailer licensing desks at (916) 650-6500.
The detailed licensing requirements for the licensing of Medical Device Manufacturers and Home Medical Device Retailers can be found by following the link to The Sherman Food, Drug and Cosmetic Law .
If you wish to inquire about a firm that may be licensed as a Medical Device Manufacturer under this program please use the following form LICENSE/REGISTRATION VERIFICATION REQUEST following the instructions printed on the form. You may fill out the form online but it must be printed at your location and sent by regular mail to the address indicated on the form.