Class Iv Medical Device Licence Amendment Application Form

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CLASS IV MEDICAL DEVICE LICENCE …

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/applic-demande/form/md_licam_im_demmhom_cla4-eng.pdf

Device Licence Application No. _____ 13. COMPATIBILITY OF INTERDEPENDENT DEVICES (For a Class IV medical device intended to be used with another Class II, III, …

Draft Class IV Medical Device Licence Amendment …

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/draft-medical-device-licence-amendment-application-form.html

1. Name (s) of Device Licence (s) Being Amended. 2. Licence Number (s) to Be Amended (provide the latest valid licence number (s)) 3. Manufacturer Information (as it appears …

Application for a Medical Device Licence Amendment for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/application-medical-device-licence-amendment-private-label.html

2. Information on the Currently Licensed Private Label Medical Device. Name of Device (as it appears on the current medical device licence): Device Class (II, III or …

Medical Device User Fee Amendments (MDUFA) | FDA

https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa

30-Day Notice. $7,065. $3,532. Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) $15,454. $3,864. † Small Business Fee: For businesses …

Fees for the Examination of an Application for a Medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html

Apr 1, 2022

Medical Devices Licence Amendment Fax-back Form

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/medical-devices-licence-amendment-form-guidance.html

The purpose of the attached form is to facilitate the approval of device licence amendments where the change involved consists of the addition or deletion of new …

Class III Medical Device Licence Amendment Application …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/class-medical-device-licence-amendment-application-form.html

If you wish to use the form, you must use the alternate format below. 1. Name (s) of Device Licence (s) Being Amended. 2. Licence Number (s) To Be Amended (provide the latest …

Class II medical device licence amendment …

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/applic-demande/form/md_licam_im_demmhom_cla2-eng.pdf

2 | Class II medical device licence amendment application form Protected B when completed For medical devices 2022/08/10directorate use device licence application …

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

Search the active Medical Devices Active Licence Listing (MDALL) to see if the product is a licensed Class II, III or IV medical device.Confirmation of device licence can be made …

HEALTH CANADA: updates fees Medical Devices from 1st April …

https://www.thema-med.com/en/2022/03/28/health-canada-updates-fees-medical-devices-from-1-april-2022/

Applications for Class II, III or Class IV licence or licence amendment – private label medical device. $ 147. $ 152. Compared to 2021, there has also been an …

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Class Iv Medical Device Licence Amendment Application Form