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Medical Device Establishment Licensing Nick Shipley Manager, Establishment Licensing, Billing and Invoicing Unit

Medical Device Establishment Licensing Nick Shipley Manager, Establishment Licensing, Billing and Invoicing Unit. September 19, 2012. Overview. Inspectorate Program Medical Device Establishment Licence (MDEL) MDEL Fees Annual Review/Amendments What’s new/Upcoming More Info/Contacts.

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Medical Device Establishment Licensing Nick Shipley Manager, Establishment Licensing, Billing and Invoicing Unit

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  1. Medical DeviceEstablishment LicensingNick ShipleyManager, Establishment Licensing, Billing and Invoicing Unit September 19, 2012

  2. Overview • Inspectorate Program • Medical Device Establishment Licence (MDEL) • MDEL Fees • Annual Review/Amendments • What’s new/Upcoming • More Info/Contacts

  3. Inspectorate Program • To deliver a national compliance monitoring and enforcement program for all products under the mandate of the Health Products and Food Branch (except food) • Medical devices • Cells, tissues and organs • Semen • Blood • Natural health products • Drugs, human and veterinary • Biologics • Pharmaceuticals

  4. Inspectorate Program

  5. Regulatory Framework • Food and Drugs Act (FDA) • Medical Devices Regulations • Establishment Licences • Financial Administration Act (FAA) • Fees In Respect of Drugs And Medical Devices Regulations • Fees, Charging

  6. Why do I need a licence? Requirement for Importers (Class I – IV) Distributors (Class I – IV) Manufacturers of Class I some exceptions It is your responsibility to know if you are selling a medical device Uncertain? device_licensing@hc-sc.gc.ca Medical Device Establishment Licence

  7. Medical Device Establishment Licence Exceptions Section 44. (2) of the MDR • The prohibition does not apply to the importation or sale of a medical device by: • A retailer • A health care facility • In the case of a Class II, III, IV medical device, the manufacturer of the medical device; or • In the case of a Class I device, the manufacturer of the medical device, if the manufacturer imports or distributes solely through a person who holds an EL

  8. Medical Device Establishment Licence How do I get a licence? • Submit complete application • Buildings must be in compliance with requirements set out in the MDR • Attestations • Health Canada Inspection (Verification of Canadian buildings) • Submit relevant fees* • 120 day service standard for issuance (average)

  9. Medical Device Establishment Licence Common Problems/Questions • I am a class I manufacturer, do I also need to have import and/or distribute on my licence? • No – unless you are importing or selling products manufactured by someone else • This can all appear on a single application/licence • I also manufacture Class 2,3,4 products and have a device licence. Can I add those activities to the MDEL? • No. Your device licence covers such activities.

  10. Medical Device Establishment Licence Common Problems/Questions • Who are the sites? • Buildings doing licensable activities under the MDEL • Who do I list as manufacturers? • If a Class I manufacturer, include yourself • If importing/distributing other products, the manufacturers of those products

  11. Medical Device Establishment Licence Common Problems/Questions • If you are also importing/distributing class II/III/IV devices, make sure the manufacturers hold device licences • Sign the application and check off all the relevant attestations

  12. How much does it cost? Flat fee for each licence $7,344 for 2012-2013 2% annual increase Small and medium businesses & Fee Remission (1% rule) New businesses & Fee Deferral (1 year rule) MDEL Fees

  13. Why did the fees go up? What do my fees pay for? MDEL Fees

  14. MDEL Fees Common Problems • Certified Statement • Submitted at time of application • Previous calendar year of sales not fiscal year. • Medical devices only • Payment and fee remission are due at time of application • Reactivation • Annual Review Non-responders • Fees for review of application

  15. Annual Review/Amendments How do I maintain my licence? • Annual review • Submit annual review application before April 1 of each year • Submit relevant fees at time of application • Licence cancelled if • No annual review application is submitted before April 1 • Annual review application is incomplete • If reapply, you are subjected to 2% increase in fees. • Amendments • Only for changes in establishment name/address or representatives name, title, telephone number • Within 15 days of change

  16. What’s New & Upcoming • Webinar in the fall • Annual review package • Electronic applications • Improved forms • FAQs • Inquiry Service Standard • New and improved Establishment Licence Listing “LiveList” now up-to-date & available year-round

  17. For more information on Establishment Licensing, Billing and Invoicing: www.healthcanada.gc.ca/establishmentlicences And see our Live List at: http://webprod3.hc-sc.gc.ca/el-le/index-eng.jsp More Information

  18. Licensing Questions MDEL_questions_LEPIM@HC-SC.GC.CA Fee Questions ELIU_UFLE@hc-sc.gc.ca Contact Us

  19. Thank You

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