Your Health and Safety Our priority Votre sant

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

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

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 Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Inspectorate Program Health Products and Food Branch Inspectorate L’Inspectorat 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 Health Products and Food Branch Inspectorate L’Inspectorat 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 Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

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, 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 Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

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) Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

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. Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

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 Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

Medical Device Establishment Licence Common Problems/Questions • If you are also importing/distributing class II/IV devices, make sure the manufacturers hold device licences • Sign the application and check off all the relevant attestations Health Products and Food Branch Inspectorate L’Inspectorat 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) Health Products and Food Branch Inspectorate L’Inspectorat 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? Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

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 Health Products and Food Branch Inspectorate L’Inspectorat 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 Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

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 “Live. List” now up-to-date & available year -round Health Products and Food Branch Inspectorate L’Inspectorat 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: //webprod 3. hc-sc. gc. ca/el-le/index-eng. jsp Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments

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

Thank You Health Products and Food Branch Inspectorate L’Inspectorat de la Direction générale des produits de santé et des aliments