1. Your Health and Votre santé et votre Safety... Our priority Securité… notre priorité Medical Device Establishment Licensing Nick Shipley Manager, Establishment Licensing, Billing and Invoicing Unit September 19, 2012

2. Your Health and Votre santé et votre Safety... Our priority Securité… notre priorité Overview Inspectorate Program Medical Device Establishment Licence (MDEL) MDEL Fees Annual Review/Amendments Whats new/Upcoming More Info/Contacts

3. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments 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. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments Inspectorate Program

5. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments 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. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments Medical Device Establishment Licence 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

7. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments 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 Medical Device Establishment Licence

8. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments 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) Medical Device Establishment Licence

9. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments 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. Medical Device Establishment Licence

10. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments 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 Medical Device Establishment Licence

11. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments 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 Medical Device Establishment Licence

12. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments MDEL Fees 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)

13. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments MDEL Fees Why did the fees go up? What do my fees pay for?

14. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments 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 MDEL Fees

15. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments 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. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments Whats 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. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments More Information 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

18. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments Contact Us Licensing Questions –MDEL_questions_LEPIM@HC-SC.GC.CAMDEL_questions_LEPIM@HC-SC.GC.CA Fee Questions –ELIU_UFLE@hc-sc.gc.caELIU_UFLE@hc-sc.gc.ca

19. Health Products and Food Branch Inspectorate LInspectorat de la Direction générale des produits de santé et des aliments Thank You