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Who Must Register, List and Pay the Fee | FDA
- https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
- 807.20 (a) (2) YES. 807.20 (a) (2) YES Contract sterilizer YES. 807.20 (a) (2) YES. 807.20 (a) (2) YES Device being investigated under IDE NO NO. 807.40 (c) NO Domestic Distributor that does not import devices NO.
Importing Medical Devices | FDA
- https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
- Registration and listing. Establishments that are involved in the production and distribution of …
MDR - Distributor Requirements (that also affect …
- https://www.johner-institute.com/articles/regulatory-affairs/and-more/distributor-requirements/
- MDR - Distributor Requirements (that also affect the manufacturers) 1. What a “distributor” is (and what it isn't) a) Definition The Medical Device Regulations (MDR) has many roles, …
Which MDR requirements apply to distributors of medical devices?
- https://decomplix.com/mdr-requirements-medical-device-distributors/
- To learn more about requirements for a distributor’s QMS, the document of the Medical Device Coordination Group may be consulted MDCG 2021-23 Guidance …
eCFR :: 21 CFR Part 803 -- Medical Device Reporting
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803
- (1) If you are a device distributor, you must establish and maintain device complaint records (files). Your records must contain any incident information, including any written, …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=821&showFR=1&subpartNode=21:8.0.1.1.13.3
- (1) The name and address of the distributor, final distributor or multiple distributor; (2) The unique device identifier (UDI), lot number, batch number, model …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=821.30
- Sec. 821.30 Tracking obligations of persons other than device manufacturers: distributor requirements. (a) A distributor, final distributor, or …
State Regulation of Medical Device Distribution
- https://www.morganlewis.com/~/media/files/publication/outside%20publication/article/fdli_medicaldevicedistribution_may-june2009.ashx
- Device distribution in the United States presents unique challenges. While all states have established regulatory programs and requirements governing the drug distribution …
General Device Labeling Requirements | FDA
- https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements
- Intended Use 21 CFR 801.4 If a packer, distributor, or seller intends a device for uses other than those intended by the person from whom he received the device, these …
Overview of Regulatory Requirements: Medical Devices
- https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
- Within FDA, the Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary …
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