Guidance Medical Device Establishment Licensing

Device Registration and Listing | FDA

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

For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: [email protected]. For assistance with policy or ...

Guidance on Medical Device Establishment Licensing …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016.html

Guidance on Medical Device Establishment Licensing …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html

This guidance document explains: Medical devices establishment licensing regime under sections 44 to 51.1 of the Medical Devices Regulations to the Food and Drugs Act. Responsibilities of any …

Review and Update of Device Establishment Inspection …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/review-and-update-device-establishment-inspection-processes-and-standards

FDA is issuing this guidance to comply with section 702 (b) (1) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA to issue guidance that …

Guidance on Medical Device Establishment …

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/pub-eng.pdf

Guidance on Medical Device Establishment Licensing (MDEL) (GUI-0016) version 8 Page 3 of 42 Disclaimer This document does not constitute part of the Food and Drugs …

Establishment Licences - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences.html

Blood Establishment Licensing Application Form and Instructions - (FRM-0354) Medical Devices. COVID-19 Medical Device Establishment Licence (MDEL) …

Medical Device Establishment Licence (MDEL) …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html

To complete this form properly, follow these seven steps: Step 1: Learn about MDEL 's. Step 2: Determine if your product is a medical device. Step 3: Determine if your activities …

MDA Guidance on Establishment Licensing: License …

https://www.regdesk.co/mda-guidance-on-establishment-licensing-license-types-and-application-process/

License for authorized representative (AR) – a license granted to an establishment that represents a foreign medical device manufacturer relating to any regulatory obligations under Act 737. In this …

GUIDANCE DOCUMENT ON LICENSING FOR …

https://www.mda.gov.my/announcement/286-guidance-document-on-licensing-for-establishment.html

GUIDANCE DOCUMENT ON LICENSING FOR ESTABLISHMENT. This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and …