your health and votre santé et votre safety... our priority securité… notre priorité medical...

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? 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

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– 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