Entering the North American Market

The Regulatory Landscape: Device Regulation in Canada

Nancy Ruth

Director, Medical Devices

AdvaMed September 21, 2008

Canadian Medical Devices Regulations (CMDR)

Authority from Food and Drug Act

Health Canada - regulator Mandate: protect Health of

citizens– Safe, effective therapeutics -

medical devices Pre-market and post-

market activities

US - CFR Food Drug and Cosmetic

Act FDA

Protection – safe/effective

Pre-market and post-market activities

Pre-market Activities

Clinical studies: Investigational Testing Authorization (ITA) US: IDE

Medical Device Licences US: 510(k), PMA

Quality system ISO 13485 certified – 3rd party recognized registrars US: QS Reg not certified; FDA inspection

Medical Device Establishment Licence: US: Establishment registration/device listing

Post-Market Activities Medical Device Establishment Licence – annual

update/renewal US: FDA Establishment registration/device listing annual update/renewal

Inspection Program for Medical Devices– Health Canada inspectors– Regulatory compliance – not quality systems– Importers, distributors, manufacturers US: FDA inspection cycle

Investigations – noncompliance, safety US: FDA

investigations

Post-market data collection, trend analysis– Mandatory problem reports, recalls, global information sharing

US: Medical Device Reports, recalls, global information

Canadian Medical Devices Regulations: Risk based classification system

• Class 1 (least risk)

• Class 2• Class 3

• Class 4 (most risk)

Canadian Medical Devices Regulations:

Licences Class 1

– No product licence needed for manufacturer– No ISO 13485 certificate– Medical Device Establishment Licence (MDEL) – product class,

medical specialty– Manufacturer can be exempt if import/distribute through MDEL holder– Retailer, healthcare institution, healthcare professional exempt– $2010** annually, attestations

** fee increases expected in 2009

Canadian Medical Devices Regulations:

Licences Class 2, 3, 4– Medical device licence – held by manufacturer*– Apply to Health Canada– Class 2 – minimal safety/effectiveness; fee $200– Class 3, 4 – premarket review document for safety/effectiveness; fees vary per

submitted information -approx $2000 - $10,000 **– Amendment for significant changes– No substantial equivalence process – stand alone submissions– Private label licence provision

• Exact product, intended use as original licence: attestation• Authorization by original licence holder – cross-reference• No ISO 13485 for private labeler

** fee increases expected in 2009

Canadian Medical Devices Regulations:

Target timelines- medical device licence review

Class 2 – 15 days + administrative Class 3 – 15 day screen, 60 day review +

administrative Class 4 – 15 day screen, 75 day review +

administrative Questions: screening, review (additional information);

new cycles Reality: some delays – notably IVDD backlog

Canadian Medical Devices Regulations:

Quality system Class 2, 3, 4 licence applications Quality system certificate submitted CMDCAS (Canadian Medical Device Conformity

Assessment System) Recognized registrar – third party

– Audit, issue certificate– 3 year cycle – certification, 2 x annual surveillance, recertification– Manufacturer contracts registrar, pays fees– Global picture

Canadian Medical Devices Regulations:

Investigational Testing Authorization Clinical study- submission to Health Canada – safety,

likelihood of achieving study purpose Class 2 fewer requirements

– Protocol, description, instructions for use, informed consent; ethics

approval/investigator agreement not submitted Class 3, 4 - higher risk, more information submitted

– Pre-clinical, bench testing, risk analysis– Manufacturing information– ISO 13485 not required but quality/safety assurance needed– Ethics board approval/investigator agreement submitted

30 day review target – authorization letter needed No fee

Canadian Medical Device Regulations: Differences - US to Canada

ISO 13485 – certified quality system – CMDCAS recognized registrar

No substantial equivalence process – more than 510(k) dossier for Class III, IV

– Review fees less costly than PMA Increasing safety documentation scrutiny

– FDA guidances may be used by Health Canada Classification correlation device/drug/NHP (natural health product) designation

correlation – Canada vs US vs ROW Manufacturer* definition

– Labeling, trade mark issues

Canadian Medical Devices Regulations:manufacturer definition

“manufacturer” means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. (fabricant)

Label, licence, QS certificate ® Trade-mark ™

US to Canada Already cleared/approved in US? QS Regulations compliance

– Based on ISO 13485:1996 – nothing contradictory– CMDCAS gap – add quality manual, CMDR compliance references– Procedures- recall, mandatory problem reporting, classification,

labeling– Recognized registrar – SCC, Health Canada– Audit – certificate– CMDR compliant labeling– Licence application – Class 2,3,4

Class 1 manufacturer – MDEL (can be exempt – import/distribute MDEL holder)

– Importer – MDEL

EU to Canada US companies already selling to EU – product already

CE marked for EU? Canada and EU are similar – QS, classification ISO 13485:2003 standard Additional specific requirements:

– CMDCAS – adds CMDR (Canadian Medical Devices Regulations)

references, recall, mandatory problem reporting, classification,

labeling, etc– Registrar recognized by SCC +Health Canada– Certificate – SCC logo, CMDCAS statement– CMDR compliant labeling

Canadian Medical Devices Regulations: Importation to Canada Medical Device Establishment Licence – entity who

imports for “sale” – Money or not – samples– Exceptions: importer of devices for Investigational Testing Authorization,

Special Access/Custom Made, retailer, healthcare professional/institution Attestations Documented procedures

– Complaints, distribution records, mandatory problem reports, recall– Shipping/handling, corrective action, installation, servicing – as applicable– Record keeping, classification, compliant labels

Domestic distributors No ISO 13485 certificate for MDEL

Comparison: US, Canada, EU

Jurisdiction Classification Quality system

Product registration Regulator

US Class 1, 2, 3By product codes for generic device types; CFR

21CFR 820QSReg;FDA inspects

Premarket submissions - 510(k), PMA cleared/approved by FDA

FDA – CDRH (PMA, 510k); Office of Compliance - inspection

Jurisdiction Classification Quality

system

Product

registration

regulator

Canada 1,2,3,4Risk based classification rules in Canadian Medical Devices Regulations -CMDR

ISO 13485:2003 CMDCASCertificateClass 2-4 -full QS Audited by recognized third party -registrars

Class 2,3,4 -Medical Device Licence Class 1 – MDEL(Medical Device Establishment Licence)-notproduct specific

Health Canada -Medical Devices Bureau (product licences)Health Products and Food Branch Inspec-torate (MDEL)

Jurisdiction classification

Quality system

Product Registration

Regulator

EU 1, 2a, 2b, 3Risk basedRules in DirectivesRisk based

ISO 13485:2003 certification by Notified Bodies -routes to conformity

CE MarkNotified Body (third party) -Safety/effectiveness - Essential RequirementsClass 2, 3Class 1 most self declared (except sterile,

measuring)

IVDD- Common

Technical

Specifications

Competent Authorities per member state; variation in Directives implement-ation

Nancy Ruthnruth@canreginc.com 905-689-39801-866-722-6734