Transcript Canadian Medical Device Regulations

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)
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Authority from Food and
Drug Act
Health Canada - regulator
Mandate: protect Health of
citizens
US - CFR
 Food Drug and Cosmetic
Act
 FDA

Protection – safe/effective
– Safe, effective therapeutics -
medical devices
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Pre-market and postmarket activities
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Pre-market and postmarket activities
Pre-market Activities
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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
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Medical Device Establishment Licence: US:
Establishment registration/device listing
Post-Market Activities
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Medical Device Establishment Licence – annual
update/renewal US: FDA Establishment
registration/device listing annual update/renewal
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Inspection Program for Medical Devices
– Health Canada inspectors
– Regulatory compliance – not quality systems
– Importers, distributors, manufacturers US: FDA inspection cycle
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Investigations – noncompliance, safety US: FDA
investigations
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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
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•
•
•
Class 1 (least risk)
Class 2
Class 3
Class 4 (most risk)
Canadian Medical Devices Regulations:
Licences
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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
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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
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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
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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
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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
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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
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30 day review target – authorization letter needed
No fee
Canadian Medical Device Regulations:
Differences - US to Canada
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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
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Increasing safety documentation scrutiny
– FDA guidances may be used by Health Canada
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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
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“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
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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
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Class 1 manufacturer – MDEL (can be exempt –
import/distribute MDEL holder)
– Importer – MDEL
EU to Canada
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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
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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
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Attestations
Documented procedures
– Complaints, distribution records, mandatory problem reports, recall
– Shipping/handling, corrective action, installation, servicing – as
applicable
– Record keeping, classification, compliant labels
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Domestic distributors
No ISO 13485 certificate for MDEL
Comparison: US, Canada, EU
Jurisdiction
US
Classification
Class 1, 2, 3
By product
codes for
generic
device
types; CFR
Quality
system
Product
registration
Regulator
21CFR
820
QSReg;
FDA
inspects
Premarket
submissions
- 510(k),
PMA
cleared/
approved by
FDA
FDA –
CDRH
(PMA,
510k);
Office of
Compliance
- inspection
Jurisdiction
Canada
Classification
1,2,3,4
Risk based
classification
rules in
Canadian
Medical
Devices
Regulations CMDR
Quality
Product
system
registration
ISO
13485:
2003
CMDCAS
Certificate
Class 2-4
-full QS
Audited by
recognize
d 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 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, 2a, 2b, 3
Risk based
Rules in
Directives
Risk based
measuring)
IVDD- Common
Technical
Specifications
Nancy Ruth
[email protected]
905-689-3980
1-866-722-6734