Medical Device Regulations

in Canada; Key Challenges

and International Initiatives
Goals of Regulatory System in Canada
• Risk based approach
• Post-market surveillance
• Global Harmonization
• International standards
• Quality systems approach
• Transparency and communication

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REGULATORY SCRUTINY INCREASES
WITH RISK
Highest

Medium Class III & IV

Premarket
Review

Class II
Lower
-Quality -Quality
Systems Systems
- Licensing -Licensing
Class I

Post Market Post Market Post Market

Health Canada’s Regulatory Model for Medical Devices

Regulatory Audit - Registrars

Quality Management System/ Risk Management - Manufacturers

Premarket Postmarket
Safety and Regulatory Oversight
Effectiveness and Enforcement
Requirements for
all device Classes Complaint
Management
Class II (NO
STED submitted) Maintenance &
Licensing Service
Class III
(premarket Corrective and
document/STED) Preventive Actions
Class IV Postmarket Clinical
(premarket Follow-up~licensing
document/STED) conditions
License HHE- licence
Amendments suspension
Regulatory Provisions - Essentials

• A manufacturer in the Regulations:

– Sells a medical device under their own name, trade-mark,
design, trade name or other name owned or controlled by
the person
– Is responsible for designing, manufacturing, assembling,
processing, labelling, packaging, refurbishing or modifying
the device, assigning it a purpose
– Performs or has someone perform on their behalf
Manufacturer = Name on the label

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Regulatory Provisions - Essentials

• The Regulations apply to:

– The sale and advertising for sale of a medical
device
– The importation of a medical device for sale or for
use on individuals, other than importation for
personal use

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Current Context and Challenges

• Rising health care costs and budget constraints

• Fast paced technological development
• Erosion of public confidence and pressures to
toughen regulatory systems
• The informed patient consumer
• Increasing focus on HTAs and regulatory
interface

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Current Context and Challenges – Pace of
Technological Change
• R&D generates competitive edge for device
companies, as in other industries
• Unlike drug world, however, device sector
develops new products faster, with shorter life
cycles
• Rate of innovation, shorter review timelines and
greater diversity/complexity of technologies
pose increasing regulatory challenges

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Current Context and Challenges – Globalisation

• Increased complexity of global supply chain

• Higher number of suppliers, with more
frequently considered ‘assemblers’
• Increased use of countries without regulatory
systems as manufacturing sites
• Differentiation between local/international,
emerging/developed markets
• Growing demands for regulatory convergence
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Increasing International Collaboration

• Canada’s regulatory framework for medical

devices has harmonized portions with those
of the FDA and EU
• Allows for opportunities for co-operation and
possible convergence
• Quality systems has been identified as a
suitable area for international convergence

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Medical Device Single Audit Program (MDSAP)

• Vision: To develop, manage and oversee a single audit program

that will allow a single regulatory audit to satisfy the needs of
multiple regulatory jurisdictions
• Long term goal: international coalition of countries dedicated to
pooling technology, resources and services to improve safety
and oversight of medical devices in a more efficient manner
that is also less burdensome for industry
• Modelled after Health Canada’s CMDCAS third party program;
draws upon best practices of Canadian and American systems
• FDA, Health Canada, Therapeutics Goods Administration
(Australia) and ANVISA (Brazil) signed a Statement of
Cooperation (November 2012) to commit to the development
and operation of this program.
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Medical Device Single Audit Program (MDSAP)

• To enable the appropriate regulatory oversight of medical device

manufacturers’ quality management systems while minimizing regulatory
burden on industry.
• To promote, in the longer term, greater alignment of regulatory
approaches and technical requirements globally based on international
standards and best practices
• To promote more efficient and flexible use of regulatory resources through
work-sharing and mutual acceptance among regulators while respecting
the sovereignty of each authority.

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MDSAP - Elements
 Initial Recognition, Surveillance, and Re-Recognition Criteria for
MDSAP Recognized Auditing Organizations (IMDRF Lead)

 Standardized Recognized AO Auditor Competency and

Competency Maintenance Requirements (IMDRF Lead)

 Standardized Regulatory Authority Assessor Competency and

Competency Maintenance Requirements (IMDRF Lead)

 Regulatory Assessment Program and Assessment Strategy for

the Recognition and Monitoring of Medical Device Auditing
Organizations (IMDRF Lead)

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MDSAP - Elements
 Standardized Audit and Assessment Models
 Auditing of a Manufacturer by an MDSAP Recognized AO
 Assessment of MDSAP Recognized AO’s by participating
Regulatory Authorities

 Standardized Rating System for Manufacturer Audit Findings

 Standardized Rating System for Recognized Auditing

Organization Assessment Findings

 MDSAP Quality Management System

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IMDRF -Medical Device Single Audit Program (MDSAP)

• The IMDRF Work Group is working on various components of

the MDSAP model
• The Work Group will develop a standard set of requirements
for auditing organizations performing regulatory audits of
medical device manufacturers.
• The documents will be applicable to competent authority
auditing groups/inspectorates, as well as third party
organizations that conduct such audits.

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MDSAP Manufacturer Audit Criteria
ISO 13485:2003
+
Specific Requirements of:

TGA
ANVISA
HC
_______ FDA________

= One Comprehensive Audit Model

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MDSAP Manufacturer Audit Cycle

• The Medical Device Single Audit Program is based on a three (3) year
audit cycle. The Initial Audit, also referred to as the “Initial Certification
Audit” is a complete audit of a medical device manufacturer’s quality
management system (QMS) consisting of a Stage 1 Audit and a Stage 2
Audit.

• The initial Audit is followed by a partial Surveillance Audit in each of the

following two (2) years and a complete Re-audit, also referred to as a
“Recertification Audit” in the third (3rd) year.

• Special Audits, Audits Conducted by Regulatory Authorities, and

Unannounced Audits are potential extraordinary audits that may occur
at any time within the audit cycle.
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MDSAP Pilot

• January 1, 2014 - Recognition of initial participating Auditing

Organizations

• June 1, 2014 – some Auditing Organizations ready to start

auditing medical device manufacturers and more will be
added as the pilot progresses.

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