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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
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 [email protected] 905-689-39801-866-722-6734