California Medical Device Registration

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Medical Device Safety Program - California

https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/MedicalDeviceSafetyProgram.aspx

The Medical Device Safety Section's mission is to provide an uncompromising standard of public health protection by assuring that medical devices produced and retailed in California are safe and effective. We accomplish our mission through …

Home Medical Device Retail Program - California

https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/HomeMedicalDeviceRetailProgram.aspx

In-State HMDR facilities supply prescription medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries. Out …

FDB Certificates and Licenses - California

https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/CertificatesandLicenses.aspx

Device Manufacturing Medical Device Manufacturing Application: New Applicant, Ownership Change, Renewal, and Relocation: CDPH 8596 Updated Fees (PDF) Home …

Durable Medical Equipment Application Information

https://www.dhcs.ca.gov/provgovpart/Pages/DurableMedicalEquipmentApplicationInformation.aspx

Home Medical Device Retailer Exemptee License, issued by the California Department of Public Health’ Food and Drug Branch, if your business includes dangerous drugs or …

X-ray Machine Registration & Compliance - California

https://www.cdph.ca.gov/Programs/CEH/DRSEM/Pages/RHB-X-ray/Registration.aspx

Radiation (X-ray) Machine Registration & Compliance. The Radiologic Health Branch (RHB) issues State certificates to medical facilities to perform mammography, registers …

FOOD AND DRUG BRANCH - California

https://www.cdph.ca.gov/Programs/CEH/DFDCS/CDPH%20Document%20Library/FDB/DeviceandDrugSafetyProgram/ProcedureMedDevLicense.pdf

License Application Submit a fully completed Medical Device Manufacturing License Application form with the required fee. To obtain an application, you may call FDB at …

Licensing Overview | MBC - California

https://www.mbc.ca.gov/Licensing/

A Postgraduate Training License is issued to an individual who has graduated from medical school, passed all required examinations, has not received either a …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Medical Device Reporting (MDR) Establishment Registration - 21 CFR Part 807 Manufacturers (both domestic and foreign) and initial distributors (importers) of …

Medicines and Medical Devices - California

https://www.cdtfa.ca.gov/taxes-and-fees/Reg1591-Text-2019.pdf

described in a license issued by the California State Board of Pharmacy wherein controlled substances, dangerous drugs, or dangerous devices are stored, possessed, …

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

Device Registration and Listing | FDA Device Registration and Listing Owners or operators of establishments that are involved in the production and distribution …

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