Establishment Licensing Unit Health Canada

Management of Applications and Performance for Drug Establishment Licences GUI-0127 Drug Establishment Licence Application Forms and Instructions FRM-0033. Guidance on Medical Device Establishment Licensing GUI-0016 2020-04-01 Medical Device Establishment Licence MDEL application.

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613-957-4147 Please retain a copy of the completed application in your file.

Establishment licensing unit health canada. In order to be considered for the publicly funded health care institution or Government organization fee exemption the applicant must indicate it on their Drug Establishment Licence Application. The guide describes what a DEL is and when it is required who is. The Medical Device Establishment Licensing Unit MDELU invites you to a free webinar session on the annual licence review ALR.

In order to expedite certificate issuance the applicant should include a completed shipping form waybill Purolator Fedex Loomis UPS Dicom etc with each. Contact information for Health Canadas Drug Establishment Licence Unit - Health Products Compliance Directorate - Regulatory Operations and Regions Branch. In this webinar youll learn how to complete sign and submit your medical device establishment licence MDEL ALR application.

Instructions FRM-0292 2020-04-01 Frequently Ask Questions FAQs - Medical Device Establishment Licensing and Fees Updated 2020-04-01 Fees for the Review of Medical Device Establishment Licence Applications. Each webinar for MDEL stakeholders can accommodate up to 500 people. To view active MDEL holders see the Medical Devices Establishment Licence Listing.

For questions about invoicing and fees for an MDEL contact the Cost Recovery Invoicing Unit by email. Medical Device Establishment Licence MDEL a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada. The standards are 120 days for the issuance of a medical device establishment licence and 250 days for the issuance of a drug establishment licence.

If the information and material accompanying an application is deemed acceptable to enable further processing the application will be accepted for review. The Guidance on Drug Establishment Licensing and Drug Establishment Licence Fee GUI-0002 is intended to explain sections C01A001 to C01A019 of the Food and Drug Regulations. The Regulations outline the responsibilities of persons who conduct licensable activities in Canada as well as Health Canadas responsibilities.

Jennifer Gadula is employed with Health Canada registered with Shared Services Canada. The guide describes what a DEL is and when it is required who is. The Regulations outline the responsibilities of persons who conduct licensable activities in Canada as well as Health Canadas responsibilities.

All Canadian drug establishments must hold since January 1 1998 an establishment licence to fabricate package label distribute import wholesale or test a drug. Forms and Instructions FRM-0033. If an auto-response is not received it means that the application remains undelivered.

It is recommended that applicants save both their sent email and the auto-response for future reference. The sessions will. Owned or operated by the Government of Canada or a province andor territory and provides health services.

The Guidance on Drug Establishment Licensing and Drug Establishment Licence Fee GUI-0002 is intended to explain sections C01A001 to C01A019 of the Food and Drug Regulations. Drug Establishment Licensing Unit Health Product Compliance Directorate - Regulatory Operations and Enforcement Branch Jeanne Mance Building 13th floor 200 Eglantine Driveway Address Locator 1913B Ottawa Ontario K1A 0K9. Establishment Licensing Billing and Invoicing Unit Health Products and Food Branch Inspectorate 250 Lanark Avenue Graham Spry Building 2nd Floor Address Locator 2002C Ottawa Ontario K1A 0K9 Fax.

How Health Canada inspects medical device establishments GUI-0064 PDF Version - 692 K Author. The position title is MDEL Unit Program Officer. A system-generated auto-response will be sent confirming that the application was delivered to Health Canadas establishment licencing inbox.

Please resubmit the application. Envoyer le formulaire de demande a. For questions about medical device establishment licensing and the application process contact the Medical Device Establishment Licensing Unit by email.

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