Your Health and Votre santé et votreSafety... Our priority Securité… notre priorité
Medical DeviceEstablishment Licensing
Nick ShipleyManager, Establishment Licensing, Billing and Invoicing Unit
September 19, 2012
Your Health and Votre santé et votreSafety... Our priority Securité… notre priorité
Overview• Inspectorate Program• Medical Device Establishment Licence (MDEL) • MDEL Fees• Annual Review/Amendments• What’s new/Upcoming• More Info/Contacts
Health Products and Food Branch Inspectorate
L’Inspectorat 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
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? [email protected]
Health Products and Food Branch Inspectorate
L’Inspectorat de la Direction générale des produits de santé et des aliments
ExceptionsSection 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
Health Products and Food Branch Inspectorate
L’Inspectorat 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
Health Products and Food Branch Inspectorate
L’Inspectorat 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
Health Products and Food Branch Inspectorate
L’Inspectorat 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
Health Products and Food Branch Inspectorate
L’Inspectorat 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
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
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
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 “LiveList” 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://webprod3.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– [email protected]
• Fee Questions– [email protected]
Health Products and Food Branch Inspectorate
L’Inspectorat de la Direction générale des produits de santé et des aliments
Thank You