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

Canadian Medical Devices Regulations (CMDR) t t t Authority from Food and Drug Act Canadian Medical Devices Regulations (CMDR) t t t Authority from Food and Drug Act Health Canada - regulator Mandate: protect Health of citizens US - CFR t Food Drug and Cosmetic Act t FDA t Protection – safe/effective t Pre-market and postmarket activities – Safe, effective therapeutics - medical devices t Pre-market and postmarket activities

Pre-market Activities t Clinical studies: Investigational Testing Authorization (ITA) US: IDE t Medical Device Pre-market Activities t Clinical studies: Investigational Testing Authorization (ITA) US: IDE t Medical Device Licences US: 510(k), PMA t Quality system ISO 13485 certified – 3 rd party recognized registrars US: QS Reg not certified; FDA inspection t Medical Device Establishment Licence: US: Establishment registration/device listing

Post-Market Activities t Medical Device Establishment Licence – annual update/renewal US: FDA Establishment registration/device Post-Market Activities t Medical Device Establishment Licence – annual update/renewal US: FDA Establishment registration/device listing annual update/renewal t Inspection Program for Medical Devices – Health Canada inspectors – Regulatory compliance – not quality systems – Importers, distributors, manufacturers US: FDA inspection cycle t Investigations – noncompliance, safety US: FDA investigations t 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) 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 t Class 1 – No product licence needed for Canadian Medical Devices Regulations: Licences t 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 t Class 2, 3, 4 – Medical device licence Canadian Medical Devices Regulations: Licences t 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 t t t Class Canadian Medical Devices Regulations: Target timelines- medical device licence review t t t 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 t t Class 2, 3, 4 licence applications Canadian Medical Devices Regulations: Quality system t t 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 t t Clinical study- submission to Health Canadian Medical Devices Regulations: Investigational Testing Authorization t t 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 t 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 t t 30 day review target – authorization letter needed No fee

Canadian Medical Device Regulations: Differences - US to Canada t t ISO 13485 – Canadian Medical Device Regulations: Differences - US to Canada t t 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 t Increasing safety documentation scrutiny – FDA guidances may be used by Health Canada t t t 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 t “manufacturer” means a person who sells a Canadian Medical Devices Regulations: manufacturer definition t “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) t Label, licence, QS certificate Trade-mark t ™ ®

US to Canada t t Already cleared/approved in US? QS Regulations compliance – Based US to Canada t t 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 t Class 1 manufacturer – MDEL (can be exempt – import/distribute MDEL holder) – Importer – MDEL

EU to Canada t t US companies already selling to EU – product already EU to Canada t t 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 t Medical Device Establishment Licence – entity Canadian Medical Devices Regulations: Importation to Canada t 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 t t Attestations Documented procedures – Complaints, distribution records, mandatory problem reports, recall – Shipping/handling, corrective action, installation, servicing – as applicable – Record keeping, classification, compliant labels t t Domestic distributors No ISO 13485 certificate for MDEL

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

Jurisdiction 1, 2, 3, 4 Risk based classification rules in Canadian Medical Devices Regulations Jurisdiction 1, 2, 3, 4 Risk based classification rules in Canadian Medical Devices Regulations CMDR Quality Product system Canada Classification registration 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 regulator Health Canada Medical Devices Bureau (product licences) Health Products and Food Branch Inspectorate (MDEL)

Jurisdiction classificatio n Quality system Product Registration Regulator EU ISO 13485: 2003 certification by Jurisdiction classificatio n Quality system Product Registration Regulator EU 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, Competent Authorities per member state; variation in Directives implement -ation 1, 2 a, 2 b, 3 Risk based Rules in Directives Risk based measuring) IVDD- Common Technical Specifications

Nancy Ruth nruth@canreginc. com 905 -689 -3980 1 -866 -722 -6734 Nancy Ruth [email protected] com 905 -689 -3980 1 -866 -722 -6734