Entering the North American Market

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Entering the North American Market

• The Regulatory Landscape Device Regulation in
  Canada
• Nancy Ruth
• Director, Medical Devices
• AdvaMed September 21, 2008

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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

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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

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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

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Canadian Medical Devices Regulations Risk based
classification system

• Class 1 (least risk)
• Class 2
• Class 3
• Class 4 (most risk)

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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

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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

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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

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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

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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

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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

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Canadian Medical Devices Regulationsmanufacturer
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

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US to Canada

• Already cleared/approved in US?
• QS Regulations compliance
• Based on ISO 134851996 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

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EU to Canada

• US companies already selling to EU product
  already CE marked for EU?
• Canada and EU are similar QS, classification
• ISO 134852003 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

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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

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Comparison US, Canada, EU
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Nancy Ruthnruth_at_canreginc.com
905-689-39801-866-722-6734