getting medical device approval in canada

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

http://www.canadafacts.org/



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

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 volume Module 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



Format of STED Document 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



Format of STED Document Submission Traceability – Class 3

Health Canada Section/ Review Areas Application Location Corresponding Summary

Technical Document (STED) Section/ Subsection Subsection (For internal

use Only) tab or section

pages

1 Background Information

1.1 Device Description

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 1.1 Device Description 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).

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guideld/ultrasound_ultrasons-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guideld/ultrasound_ultrasons-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/anim_tisseng.php



http://www.hc-c.gc.ca/dhpmps/md-im/applic-demande/guide-ld/stents_nues-eng.php

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)

http://www.hc-sc.gc.ca/dhp-mps/mdim/applic-demande/guide-ld/breast_impl_mammaires-eng.php

http://www.hc-sc.gc.ca/dhp-mps/mdim/applic-demande/guide-ld/breast_impl_mammaires-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 IV Class III

Timeline: 75 days Actual (Q1 2012) – 160 days Application Fee: $5151CDN Near patient IVD- $8772CDN License Renewal Fee: $337CDN

Timeline: 90 days Actual (Q1 2012) – 163 days Application Fee: $11,985CDN (human/animal tissue)$11,180CDN (near patient IVD) $20,431CDN License Renewal Fee: $337CDN

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 [email protected] Canada office: +1 888 254 3160

http://www.emergogroup.com/resources/regulations-canada




http://www.emergogroup.com/files/medical-device-regulatory-process-canada.pdf









http://www.emergogroup.com/services/canada

getting medical device approval in canada

Health & Medicine