Presentation is loading. Please wait.

Presentation is loading. Please wait.

Entering the North American Market

Similar presentations

Presentation on theme: "Entering the North American Market"— Presentation transcript:

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 905-689-3980 1-866-722-6734

Download ppt "Entering the North American Market"

Similar presentations

Ads by Google