1. Entering the North American Market
The Regulatory Landscape: Device Regulation in Canada
Nancy Ruth
Director, Medical Devices
AdvaMed September 21, 2008

2. 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

3. Pre-market Activities
Clinical studies: Investigational Testing Authorization (ITA) US: IDE
Medical Device Licences US: 510(k), PMA
Quality system ISO certified – 3rd party recognized registrars US: QS Reg not certified; FDA inspection
Medical Device Establishment Licence: US: Establishment registration/device listing

4. 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

5. Canadian Medical Devices Regulations: Risk based classification system
Class 1 (least risk)
Class 2
Class 3
Class 4 (most risk)

6. Canadian Medical Devices Regulations: Licences
Class 1
No product licence needed for manufacturer
No ISO 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

7. 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 $ $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 for private labeler
** fee increases expected in 2009

8. 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

9. 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

10. 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 not required but quality/safety assurance needed
Ethics board approval/investigator agreement submitted
30 day review target – authorization letter needed
No fee

11. Canadian Medical Device Regulations: Differences - US to Canada
ISO – 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

12. 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 ™

13. 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

14. 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

15. 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 certificate for MDEL

16. Comparison: US, Canada, EU
Jurisdiction
Classification
Quality system
Product registration
Regulator US
Class 1, 2, 3
By product codes for generic device types; CFR
21CFR 820
QSReg;
FDA inspects
Premarket submissions - 510(k), PMA cleared/
approved by FDA
FDA – CDRH (PMA, 510k); Office of Compliance - inspection

17. Class 2-4 -full QS Audited by recognized third party -registrars
Jurisdiction
Classification
Quality system
Product registration
regulator
Canada
1,2,3,4
Risk based classification rules in Canadian Medical Devices Regulations -CMDR
ISO 13485:
2003 CMDCAS
Certificate
Class 2-4 -full QS Audited by recognized third party -registrars
Class 2,3,4 -Medical Device Licence
Class 1 – MDEL
(Medical Device Establishment Licence)
-not
product specific
Health Canada -
Medical Devices Bureau (product licences)
Health Products and Food Branch Inspec-torate (MDEL)

18. EU Jurisdiction classification Quality system Product Registration
Regulator EU
1, 2a, 2b, 3
Risk based
Rules in Directives
ISO 13485:
2003 certification by Notified Bodies
-routes to conformity
CE Mark
Notified Body (third party) -Safety/
effectiveness - Essential Requirements
Class 2, 3
Class 1 most self declared (except sterile, measuring)
IVDD- Common Technical Specifications
Competent Authorities per member state; variation in Directives implement-ation

19. Nancy Ruth nruth@canreginc.com 905-689-3980 1-866-722-6734