Private Label Medical Devices Guidance Documents

Device Labeling | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws...

Guidance Document - Private Label Medical Devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-private-label-medical-devices.html

Guidance Document - Private Label Medical Devices 1. Purpose. The purpose of this document is to provide guidance on regulatory requirements for private label... …

Labeling - Regulatory Requirements for Medical Devices …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-regulatory-requirements-medical-devices-fda-89-4203

This publication explains label and labeling regulations and requirements for medical devices. The Food and Drug Administration has many labeling-related requirements to …

Private Labeled Devices with FDA Approval - Medical …

https://medicaldeviceacademy.com/private-labeled-devices-with-fda-approval/

Guidance documents – Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing …

Guidance - MDCG endorsed documents and other guidance

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro …

Private label for Medical devices - Ce Mark Medical

https://www.ce-mark-medical.com/knowledgebase/private-label-medical-devices/

Private label for Medical devices Private Label for Medical Device Manufacturers Private-label products (or so called private brands) are products that are manufactured …

Health Canada Guidance on Private Label …

https://www.regdesk.co/health-canada-guidance-on-private-label-medical-devices/

Jul 14, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to …

HSA | Guidance documents for medical devices

https://www.hsa.gov.sg/medical-devices/guidance-documents

Guidance documents for medical devices Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory …

Health Canada Guidance for Private Label Medical Devices

https://test.regdesk.co/health-canada-guidance-for-private-label-medical-devices/

In this document, the private label manufacturer applying for the license should provide the information about the device itself and the original manufacturer, and …