California Medical Device Regulations

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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 scientific-based investigations …

Drug Manufacturing, Medical Device, and Home …

https://www.cdph.ca.gov/Programs/CEH/DFDCS/CDPH%20Document%20Library/FDB/DeviceandDrugSafetyProgram/2020%20Drug%20and%20Device%20Report_FINAL.pdf

medical device manufacturers in California. Since 1970, CDPH has been mandated to license and inspect drug and medical device manufacturers, pursuant to H&S Code …

Medicines and Medical Devices - California

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

California Code of Regulations, Title 18, Section 1591, Medicines and Medical Devices Page 1 of 11 (a) Definitions. (1) Administer. “Administer” means the direct application of a …

Medical Device Safety and Drug Manufacturing …

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

(Note: If a medical device or drug manufactured in California is intended for animal use for the diagnosis, cure, mitigation, treatment of prevention of disease, that drug or device is …

Regulation 1591 - California

https://cdtfa.ca.gov/lawguides/vol1/sutr/1591.html

Regulation 1591. Medicines and Medical Devices. Reference: Sections 6006 and 6369, Revenue and Taxation Code, and sections 1200, 1200.1, 1204.1, and 1250, Health and …

FOOD AND DRUG BRANCH - California

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

California Health and Safety Code (H&SC) Section 111615 requires manufacturers of ... The first Medical Device Manufacturing License that is issued after an inspection or an …

State Regulation of Medical Device Distribution

https://www.morganlewis.com/~/media/files/publication/outside%20publication/article/fdli_medicaldevicedistribution_may-june2009.ashx

over-achiever, California has given two of agencies jurisdiction over the device distribution chain: the Medical Device Safety Section of the Food and Drug Device Branch (for retail …

Durable Medical Equipment Application Information

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

The Medi-Cal Application Fee Requirements for Compliance with 42 Code of Federal Regulations Section 455.460 ... Home Medical Device Retailer Exemptee License, …

Overview of Device Regulation | FDA

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

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

Guide to California Medical Waste Regulations | Daniels Health

https://www.danielshealth.com/knowledge-center/guide-california-medical-waste-regulations

Additional governing regulations are also mandated by California’s Health & Safety Codes 117600 to 118320, as well as regulations under the California Code of Regulations (CCR) Title 22, Division 4.5. For example: Hazardous Waste Management System: General (Chapter 10, §66250 - §66260.210)

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