Refurbished Medical Devices Regulations

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Remanufacturing and Servicing Medical Devices | FDA

https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/remanufacturing-and-servicing-medical-devices

Remanufacturing of Medical Devices | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remanufacturing-medical-devices

Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff June 2021 Download the Draft Guidance Document Read …

Federal Register :: Refurbishing, Reconditioning, …

https://www.federalregister.gov/documents/2016/03/04/2016-04700/refurbishing-reconditioning-rebuilding-remarketing-remanufacturing-and-servicing-of-medical-devices

Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or …

Reprocessing of Reusable Medical Devices: Information …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/reprocessing-reusable-medical-devices-information-manufacturers

This includes the FDA; manufacturers responsible for providing adequate reprocessing instructions that are user-friendly and proven to work; health care facilities responsible …

Regulatory Framework for Control of Refurbished …

http://mddb.apec.org/Documents/2012/MAG/WKSP1/12_mag_wksp1_011.pdf

Refurbishment Principles of Good Refurbishment Practices (GRP) Refurbishment Definition“a systematicprocess that ensures safety and effectiveness of the medical …

MEDICAL DEVICE GUIDANCE DOCUMENT GOOD …

https://www.fdanews.com/ext/resources/files/2016/03/03-16-MDBGRPMD.pdf?1457384362

this document will be on the process of refurbishing used medical devices to ensure that they adhere to the stipulated safety and effectiveness standards. This …

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

General controls require that all medical devices be properly labeled. Also, general controls require that all manufacturers, user facilities, and importers report when there's been an …

Placing on the market of fully refurbished medical devices

https://www.mdc-ce.de/fileadmin/user_upload/Downloads/Leitlinien/NB-Med/Recommendation-NB-MED-2_1-5_rev5_Placing_on_the_market_of_fully_refurbished_medical_devices.pdf

refurbishing of a medical device by the user for his own use; sale or supply of devices which have already been placed on the Community market (e.g. pre-owned or „second …

REFURBISHMENT OF MEDICAL EQUIPMENT …

https://ati.ec.europa.eu/sites/default/files/2020-05/analytical_report_nr4_refurbishment_final.pdf

out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilization and related procedures, as well as testing and restoring the technical and …

FIRST EDITION GUIDANCE DOCUMENT MDA/GD/0060: …

https://mda.gov.my/announcement/860-first-edition-guidance-document-mda-gd-0060-refurbished-medical-device-requirements.html

FIRST EDITION GUIDANCE DOCUMENT MDA/GD/0060: REFURBISHED MEDICAL DEVICE-REQUIREMENTS. This Guidance Document was prepared by the Medical …

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