Device Licensing Services Division Medical Devices Bureau

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Management of Applications for Medical Device Licences

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-licences-investigational-authorizations.html

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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 …

Frequently Asked Questions about Licensing - Medical …

https://www.dshs.texas.gov/medical-device-manufacturers-distributors/licensing-requirements-medical-device-manufacturers-distributors

A manufacturer who also distributes other manufacturer’s devices at the same location, only needs to license as a device manufacturer. However, the licensing fee is based on the …

Manufacturer and distributor registration information

https://www.mass.gov/service-details/manufacturer-and-distributor-registration-information

Medical device manufacturer and distributor registration This policy is intended to assist manufacturers and/or distributors of medical devices in Massachusetts to ascertain …

Medical Devices Directorate – Health Canada - Canada.ca

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/medical-devices-directorate.html

The Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use. Before authorizing the sale of a medical device in Canada, we verify that the …

Medical Device Manufacturers and Distributors | Texas …

https://www.dshs.texas.gov/medical-device-manufacturers-distributors

To become licensed as a medical device manufacturer or distributor, please visit the licensing requirements page, which outline options for online licensing and renewal as …

Medical Device Division

https://health.gov.il/English/MinistryUnits/HealthDivision/MedicalTechnologies/MLD/Pages/default.aspx

The Medical Device Division deals with licensing and supervision process for all types of medical devices and equipment, including rehabilitation and mobility devices, from the …

Regulated Product Submission Table of Contents Pilot

https://www.imdrf.org/regulated-product-submission-table-contents-pilot

To request formal participation confirmation manufacturers must email the IMDRF ToC Coordinator, copying all relevant regional pilot contacts (i.e. only those that …

FDB Certificates and Licenses - California

https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/CertificatesandLicenses.aspx

Device Manufacturing Medical Device Manufacturing Application: New Applicant, Ownership Change, Renewal, and Relocation: CDPH 8596 Updated Fees (PDF) Home …

Department of Health | Medical Device …

https://www.mdd.gov.hk/en/home/index.html

Announcement of the continuance of trial schemes for accepting marketing approvals obtained from the National Medical Products Administration and the Ministry of Food …

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