Canadaapprovalprocess final13june2012-130116090730-phpapp01

The medical device registration process in Canada
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA | MIDDLE EAST EmergoGroup.com
Medical Device Registration in Canada
How to obtain regulatory approval to
market your medical device in the
Canadian market

Key Topics
•Device Classification according to Canadian Medical Devices
Regulations (CMDR)
•Medical Device Establishment Licenses (MDEL)
•Medical Device Licenses (MDL)
•ISO 13485 Quality System Implementation
•Quality System Auditing
•Premarket Review Document Preparation
•Timeframes and Costs

Canada: Large Country, Small Population
World’s second largest country.
9,984,670 km² (3,855,103 mi²).
34.5 million people
Sources: Canada Facts, www.canadafacts.org
Natural Resources Canada , www.nrcan.gc.ca

Overview of Canada’s Medical Device Market
• $6 billion in annual revenues
• $2.4 billion in annual exports,
primarily to the US
• 1,500 Canadian medical device
firms with 35,000 employees
• Industry concentrated in Ontario and
Quebec (80% of Canadian medical device
firms located in these provinces)
Sources: MEDEC, Invest in Canada

Determining Device Classification
First, determine your device’s classification
using the Canadian Medical Devices
Regulations (CMDR).
Class I Class II Class III Class IV
Low Risk High Risk
http://www.emergogroup.com/files/canada-medical-devices-regulations-v2.pdf

• For Non-IVDD – 16 Rules
addressing invasive/non-
invasive/ active / special
devices
•Keyword Index
• Medical Device Active
Licence Listing
(www.mdall.ca)

• For IVDD – 9 Rules
addressing intended use /
indications for use
•Keyword Index
(draft)
• Medical Device Active
Licence Listing
(www.mdall.ca)

Examples of Classifications
• Medical Devices:
– Class I: band-aids, compression, non-invasive
– Class II: condoms, invasive, blood pressure monitors
– Class III: laser devices, blood touching, implants
– Class IV: human tissues, active implantables
• In Vitro Diagnostics:
– Class I: microbiology tests, everything else
– Class II: patient management, moderate level diagnostics
– Class III: sexually transmitted diseases, moderate to high level
– Class IV: death or serious injury diseases, detecting high level diagnostics

Class I Manufacturers
If you are a manufacturer and plan to sell a Class I
device in Canada without using an established
Canadian distributor, you must apply for a
Medical Device Establishment License (MDEL).

Classes II-IV Manufacturers
If you are a manufacturer and plan to sell Class II,
III and IV devices in Canada, regardless of whether
you are using a distributor or not, you must apply
for Medical Device Licenses (MDL) as part of the
Canadian registration process.

Importers & Distributors: All Device Classes
All distributors and importers, whether based in
Canada or not, must apply for a Medical Device
Establishment License (MDEL).

Medical Device Establishment Licence
(MDEL)
The purpose of the MDEL is
1. To ensure that Health Canada is aware of:
a) importers and/or distributers of medical devices in or into Canada,
b) the identity of the manufacturers of the devices sold by the holder of
the MDEL
c) the identity of Class I device manufacturers who distribute their own
devices.
2. To require licence holders to provide some assurance to Health
Canada that they have met the regulatory requirements, including
having the required documented procedures in place

MDEL: Key Elements
• Completed Medical Device Establishment License,
including a list of the manufacturers of all devices
imported and/or distributed
• Quality System Procedures (SOPs) addressing the
requirements of the Canadian Medical Devices
Regulations
• MDEL Fee Form

Medical Device Licence (MDL)
• Only a “Manufacturer” can apply for a Medical
Device Licence
– 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.

Classes II-IV Medical Device Licenses:
Quality System Requirements
Manufacturers of Class II, III and IV
devices are required to implement
quality systems compliant with ISO
13485:2003 in Canada.
(Health Canada does not require ISO
13485 for Class I devices.)

ISO 13485 Compliance
ISO 13485 certification requires you to develop written
policies for the following functions:
•Document and record controls
•Internal auditing procedures
•Controls for non-conformance
•Corrective and preventative actions
•Process and design controls
•Record retention practices
•Accountability and traceability
Except Class 2
Devices
Health Canada requires that the written procedures address
the requirements as listed in the Canadian Medical Devices
Regulations

Quality System Auditing
• Your ISO 13485 quality system
must be audited by a Registrar
accredited under the Canadian
Medical Devices Conformity
Assessment Scheme (CMDCAS) by
Health Canada.

Quality System Auditing
• Following a successful audit, you will receive
your ISO 13485: 2003 certification.
NOTE: Health Canada has issued a new guidance
document addressing the content of the ISO
Registrar’s Quality Management System Audit
Report (GD211)

MDEL and MDL Applications
Class I
Manufacturer
Class II
Manufacturer
Submit MDEL
application to HC
with details on
your Class I device
Submit MDL
application, ISO
13485 certificate,
IFU and
Declaration of
Conformity to HC
Distributor
Importer
Submit MDEL
application to HC
with list of
manufacturers

MDEL and MDL Applications
Class III
Manufacturer
Class IV
Manufacturer
Submit MDL application, ISO 13485
certificate, IFU, Declaration of
Conformity and Premarket Review
Document to HC

Class III and IV: Premarket Review
Document
Class III and IV device manufacturers must
prepare a Premarket Review Document along with
an MDL application.

Elements of Premarket Review Document
Health Canada requires clinical trial data to be
included in your Premarket Review Document for Class
IV devices. Data from clinical trial conducted in other
medical device markets may be accepted.
•Summary of safety and effectiveness studies
•Risk assessment
•Quality plan*
•Device-specific detailed information
•Labeling information
•Quality system requirements
•Sales & Marketing Summary

• Effective November 1, 2011 all applications for Class III
and IV Medical Device Licenses (non-IVDD) are strongly
recommended to follow the Summary Technical
Documentation (STED) format with the Health Canada
specific requirements
• All applications for Class III and IV Medical Device
Licenses need to be submitted in both paper and
electronic formats, where the electronic format is a
duplication of the paper submission following Health
Canada’s Guidance
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-
im/activit/announce-annonce/notice_e-form_class_iii_iv_avis-eng.pdf
Format of Premarket Review Document

Format of STED Document
Table of Contents
Section/Sub-section Main Heading Application Location
tab or
section
pages volumeModule 1 Health Canada Requirements
1.0 Table of Contents
2.0 Administrative Information
2.1 Application Form and Fee Form
2.2 Quality Management System Certificate
3.0 Pre-Submission Correspondence
4.0 Additional Class III Premarket Information
4.1 Cover Letter
4.2 Executive Summary
4.3 Submission Traceability Table for Class III Applications
4.4 Licence Amendments
4.5 Design Philosophy
4.6 Indications and/or Intended Use and Contraindications
4.7 Marketing History/Regulatory Status
4.7.1 Canadian
4.7.2 International
4.7.3 Incident Reports and Recalls
4.8 Standards (Health Canada Declaration of Conformity)
4.9 Shelf Life Validation for Product
4.10 Summaries
4.11 Bibliography

Table of Contents
Section/Sub-section Main Heading Application Location
tab or
section
pages volume
Module 2 Summary Technical Document (STED)-based
Requirements
5.0 Device Description and Product Specification,
Including Variants and Accessories
5.1 Device Description
5.2 Product Specification
5.3 Reference to Similar and Previous Generations of the
Device
6.0 Labelling
7.0 Design and Manufacturing Information
7.1 Device Design
7.2 Manufacturing Process
7.3 Design and Manufacturing Sites
8.0 Essential Principles (EP) Checklist
9.0 Product Verification and Validation
9.1 General
9.2 Biocompatibility
9.3 Medicinal Substances
9.4 Biological Safety
9.5 Sterilization
9.6 Software Verification and Validation
9.7 Animal Studies
9.8 Clinical Evidence

Submission Traceability – Class 3Health Canada Section/ Review Areas Application Location Corresponding Summary
Technical Document (STED) Section/
SubsectionSubsection (For internal
use Only)
tab or
section
pages
1 Background Information
1.1.1 General Device Description 6.1, 6.2, 11.3
1.1.2 Licence Amendments Not Applicable (N/A)
1.2 Design Philosophy 6.1 c) 6.3
1.3 Indications and/or Intended Use N/A
2 Device Labels, Package Labelling and
Documentation
7
3.0 Marketing History/Regulatory Status N/A
3.1 Canadian
3.2 International
3.3 Incident Reports and Recalls
4 Safety and Effectiveness Studies
4.1 Standards 11.1 a) b) 3rdpara.
4.2 Preclinical Studies
4.2.1 Physical/Mechanical/Bench Tests 11.1 a)b)c) 2ndPara
4.2.2 Shelf Life Studies of Product N/A
4.2.3 Software Verification and Validation 11.6
4.2.4 Biocompatibility Tests 6.1f), 11.2
4.2.5 Animal Studies 11.1, 11.7
4.3 Clinical Evidence 11.8,GHTF/SG5/N2
4.4 Sterilization 11.5
4.5 Literature Studies and Bibliography 11.1 e) 2ndpara.

Format of Class III MDL - IVDD

Format of Class IV MDL – IVDD
Device Licence Application Form
Executive Summary
Table of Contents
1 Background Information
1.2 Design Philosophy
1.3 Marketing History
2 Risk Assessment
3 Quality Plan
4 Device Specific Detailed Information
4.1 Material Specifications
4.2 Manufacturing Process Specifications
4.2.1 Method of Manufacture
4.2.2 Quality Control Activities
4.3 List of Standards
5 Safety and Effectiveness Studies
5.1 Preclinical and Clinical Studies
5.1.1 Sensitivity/Specificity
5.1.2 Validation of Cutoff
5.1.3 Interference
5.1.4 Reproducibility
5.1.5 Stability
5.2 Process Validation Studies
5.3 Software Validation Studies (if applicable)
5.4 Literature Studies
5.5 Other Studies
6 Additional information for Near-Patient IVDDs (if applicable)
7 Device Label
8 Quality System Audit

Device-Specific Guidance Documents
• Device Licence Applications for Ultrasound Diagnostic Systems
and Transducers (http://www.hc-sc.gc.ca/dhp-mps/md-
im/applic-demande/guideld/ultrasound_ultrasons-eng.php).
• Guidance Document on the Regulation of Medical Devices
Manufactured From or Incorporating Viable or Non-Viable
Animal Tissue or their Derivative(s) (http://www.hc-
sc.gc.ca/dhp-mps/md-im/applic-demande/guide-
ld/anim_tisseng.php).
• Pre-Market Guidance on Bare Cardiovascular Stents
(http://www.hc-c.gc.ca/dhpmps/md-im/applic-
demande/guide-ld/stents_nues-eng.php).

Device Specific Guidance Documents, cont’d.
• Preparation of a Premarket Review Document for Breast
Implant and Tissue Expander Device Licence Applications
(http://www.hc-sc.gc.ca/dhp-mps/mdim/applic-
demande/guide-ld/breast_impl_mammaires-eng.php).
• Consultation on the Release of Draft Guidance Document-
Medical Device Applications for Implantable Cardiac Leads
(http://www.hc-sc.gc.ca/dhpmps/consultation/md-
im/consult-draft_ebauche_cardi_lead_sondes-eng.php)

Timeline:
Goal < 120 days
Reality ≈ 60 days
Annual License Fee: $7344CDN
(can be reduced to 1% of actual
gross revenue)
Timeline: 15 days
Actual (Q1 2012) – 24 days
Application Fee: $357CDN
License Renewal Fee: $337CDN
Licence Review
MDEL Class II
Fees are due at time of submission
Fee remission (based 1% of gross revenues in
Canada) can be requested for MDEL applications

MDL Review
Class IVClass III
Timeline: 75 days
Application Fee: $5151CDN
Near patient IVD- $8772CDN
Timeline: 90 days
Application Fee: $11,985CDN
(human/animal tissue)$11,180CDN
(near patient IVD) $20,431CDN
Fees will be invoiced to company after submission
Companies can request fee remission or a one –year
fee deferral (for new companies only)

MDEL and MDL Approval
For Class I MDEL devices, Health Canada issues a MDEL
Certificate, which is re-issued annually*
For MDL applications, Health Canada issues a MDL
certificate and post the approval status on its website
(www.mdall.ca).

Sample MDEL Sample MDL

Private Label Medical Device Licence
(PLMDL)
• "private label medical device" - a medical device
that is identical in every respect to a licensed
medical device manufactured by an original
manufacturer, except that the device is labelled
with the private label manufacturer’s name,
address and product name and identifier.
• The Private Label “manufacturer” does not require
certification to ISO 13485; however, they do
require Quality System Procedures similar to those
for holders of MDELs

Private Label Medical Device Licence
(PLMDL)
• Essentially an agreement between the Private
Label “manufacturer”, the original equipment
manufacturer and Health Canada
• There are no fees for the review of the application
• Review timelines are comparable for Class II
devices and much shorter than those for Class III
and Class IV devices

Completion of Registration
You are now approved to sell your medical device in Canada.
Health Canada requires annual license renewals and fees to
maintain your registration.

Licence Updates/ Renewals - MDL
• Updating ISO Certificates – Form F-202 to be submitted
within 30 days of issuance
• Company relocation – Fax-Back Form + F-202
• Company name change - Fax-Back Form + F-202
• Device name changes or changes to parts – Fax-Back
Form
• Discontinue sale of medical device – within 30 days
• Annual licence renewals are due before November 1 using
form supplied by Health Canada (fees will be invoiced)

Licence Updates/ Renewals - MDEL
• Company relocation / company name change /
change to company contact – noptify Health
Canada within 15 days using MDEL Form
• Annual licence renewals are due before April 1
using MDEL form – Fees are due at time of
renewal – however, a fee remission can be
requested*
* Due to large volume of MDEL renewals, companies are recommended to submit
MDEL renewals as early as possible to avoid delays in renewal of the licence

For additional information:
http://www.emergogroup.com/resources/regulations-canada
Medical device regulations in Canada:
Medical device regulatory process chart for Canada:
http://www.emergogroup.com/files/medical-device-regulatory-process-canada.pdf
http://www.emergogroup.com/services/canada
Consulting services for Canada:
Questions?
Daryl Wisdahl
EMERGO GROUP | Managing Director, Canada
dw@emergogroup.com
Canada office: +1 888 254 3160

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