Supplement-Checklist for the assessment in accordance with
ISO 13485 under CMDCAS
1. Purpose
This checklist is a supplement to Supplement Assessor Guideline MDD and CMDCAS 780E1, and the
Checklist for the Assessment in Accordance with the Standards ISO 13485 etc. 780E1_E. It describes the
auditing procedure for quality management systems according to ISO 13485 under the Canadian Medical
Devices Conformity Assessment System (CMDCAS) based on the Health Canada guidance documents GD 207
(November 2007) and GD 210 (January 2007).
This document replaces the previous version based on the previous versions of Health Canada guidance
documents.
2. Scope
This checklist is applicable for the certification and oversight of the quality systems of the manufacturers of class
II, III and/or IV medical device(s) according to the Canadian Medical Devices Regulations, who have submitted
or are intending to submit an application for Medical Device Licence(s) to Health Canada.
3. Responsibilities and authority
Lead auditor
The lead auditor is responsible for the examination and evaluation of the QM system in respect of the
customer’s system documentation, the related standards and the ruling according to ISO 13485 and the
additional requirements under the CMDCAS program.
He is responsible for the work of the audit team and for the observance of the DQS processes. In case where
the lead auditor is not an expert himself, he should accept the evaluation of the conformity under CMDCAS by
the expert without any protest.
Expert
The expert is responsible for the competent evaluation of the aspects of the QM system that are specific under
the CMDCAS program. The assessment of the quality system’s effectiveness in terms of ensuring observance
of the Canadian Medical Devices Regulations, especially those parts applicable to class II, III and/or IV medical
devices, is his essential task.
4. Approach to the evaluation
This checklist can be applied only in combination with the checklist 780E1_E. The requirements included in
this checklist should be audited along with the corresponding parts of the general ISO 13485 requirements
using the process approach, as outlined in the checklist 780E1_E, and not as a separate part of the audit
schedule.
All nonconformities shall be reported directly against a requirements of ISO 13485 and never directly
against a section of the MDR. If the manufacturer has not adequately addressed one or more applicable
requirements of the MDR, the nonconformity shall be cited against the corresponding ISO 13485
requirement, with reference to the missing section of MDR as objective evidence to support the
nonconformity. If the suitable ISO 13485 requirement cannot be found, the nonconformity can be
reported against the clause 4.2.1.
The present checklist must be used as instrument to perform the assessment.
The assessment results must be formulated in the audit report, where a reference to this checklist can be made.
5. Further applicable documents




780E1 Assessors Guideline Supplement
780E1_E-Checkliste-ISO13485-2003-9342EWG-9001
Canadian Medical Devices Regulations (MDR)
(latest version available from Justice Canada at http://laws.justice.gc.ca/en/F-27/SOR-98-282/text.html)
Health Canada guidance documents, especially GD 207 and GD 210
(available from Health Canada homepage at http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/indexeng.php)
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
Health Canada Medical Devices Active Licence Listing at http://www.mdall.ca (MDALL), and
Medical Devices Establishment Licence (MDEL) Listing at http://www.hc-sc.gc.ca/dhp-mps/compliconform/licences/index-eng.php
 and other further applicable documents and standards referenced.
The original text of MDR, GD210, GD207, and the current manufacturer’s licence listings (MDALL, MDEL)
must be available to the audit team during the audit.
6. Application of the assessment checklist
The checklist serves for the evaluation of audit results. Each audit requirement should be evaluated separately.
The evaluation of the documentation and implementation of a standard’s requirement should be documented in
the column “Evaluation” in the following way:
1 = fulfilled
2 = partially fulfilled, still acceptable
3 = partially fulfilled, not acceptable
4 = not fulfilled
na = not applicable
The numbering of the questions corresponds to the numbers of the requirements as printed in ISO 13485 and
GD 210 (in the italic font).
7. Audit protocol
Please use the DQS form “Findings“ (“Feststellungen“). The findings must contain a reference to the standard’s
requirements. These can be entered in the column “Reference” (“Referenz”). Please use the numbering system
of the standard using at least two digits of the requirement’s number (e.g. 4.2 for “Documentation
Requirements”). Additional evidence, such as copies of manufacturer’s documentation, should be identified
clearly (e.g. using the numbers).
8. Abbreviations
CMDCAS
MDR
HC
SCC
QMS
Canadian Medical Devices Conformity Assessment System
Canadian Medical Devices Regulations
Health Canada
Standards Council of Canada
quality management system
Ref. No.:
Company:
Date(s) of Audit
Auditor’s Name
Auditor’s Signature
Initial / Re-Certification
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Checklist Section 2
ISO
13485
clause
Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
(re)cert.
1
Scope
1.1
General
This International Standard specifies
requirements for a quality management
system where an organization needs to
demonstrate its ability to provide medical
devices and related services that
consistently meet customer requirements
and regulatory requirements applicable to
medical devices and related services.
Most recent consolidated version of
Part 1, Medical Devices Regulations
(MDR)
It says that ISO 13485:2003 shall be used by a Manufacturer to demonstrate
that it can provide medical devices that meet customer as well as regulatory
requirements.
1.2
Application
If regulatory requirements permit
exclusions of design and development
controls (see 7.3), this can be used as a
justification for their exclusion from the
quality management system. These
regulations can provide alternative
arrangements that are to be addressed in
the quality management system. It is the
responsibility of the organization to ensure
that claims of conformity with this
International Standard reflect exclusion of
design and development controls [see
4.2.2 a) and 7.3].
32(2)(f) permits exclusion of Design
and development controls (element
7.3) from the QMS for Class II medical
devices.
Are any exclusions (e.g. ISO 13485 clause 7.3) and non-applicabilities (e.g.
clauses 7.5.1.2.2 and 7.5.1.2.3) of clauses from ISO 13485 supported with
details of the justification in the quality manual?
The manufacturer cannot exclude Design and development controls if their
intention is to obtain a class III or IV device licence.
Does the audit scope include, for Class II devices, manufacture [production], for
Class III or IV devices, design and manufacture, for all medical devices for
which the Medical Device Licences exist or an application is planned?
Review with the MDALL database:
manufacturer on the Licence = manufacturer on the CMDCAS certificate
licenced medical device’s type and class correspond to the medical
device’s generic definition of the certificate
3
Terms and definitions
Existing ISO 9000:2005 and ISO
13485:2003 definitions.
...definitions should be regarded as
generic, as definitions provided in national
regulations can differ slightly and take
precedence.
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This is not a requirement clause of ISO 13485:2003 but is meant to inform the
reader. Where this a conflict of definitions, the MDR definitions take
precedence.
Part 1, Section 1 Interpretations
In the MDR "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.
The MDR holds the "Manufacturer" responsible for the safety and effectiveness
of the medical device. The Manufacturer shall be certified to ISO 13485:2003 by
a Health Canada Recognized Registrar.
QMS certificates must be issued to the organization that meets the MDR
definition of the Manufacturer.
Does the manufacturer meet his regulatory definition?
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ISO
13485
clause
Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
(re)cert.
3.3
Advisory notice
notice issued by the organization,
subsequent to delivery of the medical
device, to provide supplementary
information and/or to advise what action
should be taken in
the use of a medical device,
the modification of a medical
device,
the return of the medical device
to the organization that supplied
it, or
the destruction of a medical
device
NOTE Issue of an advisory notice might be
required to comply with national or regional
regulations.
4
Quality management system
4.1
General requirements
The organization shall...identify the
processes needed for the quality
management system and their application
throughout the organization (see 1.2)...
Where an organization chooses to
outsource any process that affects product
conformity with requirements, the
organization shall ensure control over such
processes. Control of such outsourced
processes shall be identified within the
quality management system (see 8.5.1).
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Part 1, Section 1 Interpretations
"recall", in respect of a medical device
that has been sold, means any action
taken by the manufacturer, importer or
distributor of the device to recall or
correct the device, or to notify its
owners and users of its
defectiveness or potential
defectiveness, after becoming aware
that the device
a. may be hazardous to health;
b. may fail to conform to any
claim made by the
manufacturer or importer
relating to its effectiveness,
benefits, performance
characteristics or safety; or
c. may not meet the
requirements of the Act or
these Regulations.
The intent of a regulatory "recall" is consistent with the ISO "advisory notice".
2, 3, 5 Application
6, 7 (including Schedule 1)
Classification
26 Prohibition
28 to 31 Devices deemed licensed
32, 33 Application for a device licence
34 Amendment to a device licence
43 Obligation to inform
43.1 Obligation to submit certificate
If some of the MDR requirements have been delegated by the legal
Manufacturer to another area of the organization, has the delegation of
responsibility been clearly defined and documented?
Is there more than one geographic location which is used in the design and
manufacturing process?
Is there a designated regulatory correspondent?
If YES → the regularory correspondent is to be involved in the audit!
Offsite auditing using the document review and/or distant communication is
possible.
REGULATORY CORRESPONDENT is a person that is officially authorized by
the manufacturer to be its contact with HC with respect to its licenced devices.
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Does the Manufacturer have control over all outsourced processes and are
these control mechanisms identified within the QMS?
The MDR hold the "Manufacturer" responsible for the safety and effectiveness
of the medical device including the design, fabrication, assembly, sterilization,
shipping etc. The Manufacturer must demonstrate control over these processes.
(A) Is the manufacturer responsible for its finished medical devices meeting
regulatory safety, effectiveness and QMS requirements regardless of whether
the manufacturer has outsourced the supply of parts, material, services or
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Additional Guidance under GD210 and GD207
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MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
(re)cert.
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finished medical devices?
(B) Does the supplier have a substantial involvement with the manufacture or
design of the medical device?
Is the supplier undertaking the supply of a part, material or service, which may
affect the conformity of the medical device with the Safety and Effectiveness
requirements of MDR?
If the answer is YES to (A) or (B) →
Is there enough objective evidence at the legal manufacturer’s location that
shows the competence of the supplier (subcontractor) to undertake supply of
the part, material or service in relation to the medical devices that are
manufactured or designed under the scope of the registered QMS?
Such evidence is to be especially evaluated in terms of the control and risk
mitigation by the manufacturer over the supplier and their products/services,
e.g.:

design and product requirements

personnel qualifications

verification that subcontracted products meet specified requirements

specifying a QMS under which the subcontracted products are
designed and manufactured

performing the on-site inspections

validating processes

a QMS certificate with which DQS has confidence
o issued by a HC recognized registrar
(look up in the listing at the HC homepage)
o accredited (by SCC) and not expired
o covering the parts, material, service or finished medical
devices used by manufacturer
or a demonstration of manufacturer’s adequate controls / risk management of
the outsourced product / process.
4.2
Documentation requirements
4.2.1
General
The quality management system
documentation shall include...f) any other
documentation specified by national or
regional regulations.
Where this International Standard specifies
that a requirement, procedure, activity or
special arrangement be "documented", it
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9(2) A manufacturer shall keep
objective evidence to establish that the
medical device meets those
requirements. [safety and
effectiveness]
10 to 20 Safety and Effectiveness
Requirements
32 Application for a Medical device
Does the Manufacturer have files (often called the Technical File or Device
Master File) that contain, or refers to the location of the evidence of safety and
effectiveness required in Sections 10 to 20?
These files, or parts of them, can be used to satisfy the :
Class II licence application requirements of Sections 32(1) and (2);
Class III licence application requirements of Sections 32(1) and (3); or
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Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
(re)cert.
Licence
For Class II devices refer to 32(1) and
(2) for minimum requirements.
For Class III devices refer to 32(1) and
(3) for minimum requirements.
For Class IV devices refer to 32(1) and
(4) for minimum requirements.
Class IV licence application requirements of Sections 32(1) and (4).
Have these regulatory requirements been documented in the Quality Manual?
→ Refer to the original wording of MDR sec. 31(1) – 31(4) for the minimum
requirements.
The organization shall establish and
maintain a quality manual that includes...a)
the scope of the quality management
system, including details of and justification
for any exclusion and/or non-application
(see 1.2)...
32(2) f) Application for a Class II
device licence - QMS requirement
Applicable only to Class II medical device Manufacturers
If the Manufacturer excludes element 7.3 Design and development from the
scope of the QMS, does the quality manual contain a detailed justification of its
exclusion?
Is the justification based on the Section 32(2)(f)?
4.2.3
Control of documents
Existing ISO 13485:2003 QMS
requirements.
No specific requirement in MDR.
Does the Manufacturer have the most recent consolidated version of the MDR
including any amendments published in Canada Gazette Part II?
http://laws.justice.gc.ca
http://canadagazette.gc.ca/
4.2.4
Control of records
The organization shall retain the records
for a period of time at least equivalent to
the lifetime of the medical device as
defined by the organization, but not less
than two years from the date of product
release by the organization or as specified
by the relevant regulatory requirement.
55, 56 Distribution records
66 to 68 Implant registration
Has the Manufacturer identified the lifetime of the medical devices?
Has the Manufacturer defined the record retention period for distribution records
in respect of a medical device for the longer of (a) the projected useful life of the
device, or (b) two years after the date the device is shipped?
5
Management responsibility
5.1
Management commitment
Top management shall provide evidence of
its commitment to the development and
implementation of the quality management
system and maintaining its effectiveness
by...communicating to the organization the
importance of meeting customer as well as
statutory and regulatory requirements....
No specific requirement in MDR.
Does objective evidence exist of top management's commitment to meeting the
requirements of the Canadian MDR? ( e.g. Device Licensing, Mandatory
Problem Reports, Recalls etc.)
shall, in addition, be implemented and
maintained.
For each type or model of medical device,
the organization shall establish and
maintain a file either containing or
identifying documents defining product
specifications and quality management
system requirements (see 4.2.3). These
documents shall define the complete
manufacturing process and, if applicable,
installation and servicing.
4.2.2
Evaluation
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Quality manual
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Checklist Section 2
ISO
13485
clause
Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
(re)cert.
st
1
adv.
No specific requirement in MDR.
5.2-5.5
5.6
Management review
5.6.2
Review input
6
Resource management
6.2.2
No specific requirement in MDR.
Is a review of new or revised MDR part of the input to management review?
Competence, awareness and training
No specific requirement in MDR.
Have the people who perform regulatory activities been trained in the
understanding of the MDR?
6.3
Infrastructure
The organization shall determine, provide
and maintain the infrastructure needed to
achieve conformity to product
requirements. Infrastructure includes, as
applicable
a. buildings, workspace and
associated utilities,
b. process equipment (both
hardware and software), and
c. supporting services (such as
transport or communication).
14 Transport and storage
Does the Manufacturer have and maintain the necessary infrastructure to
ensure that the characteristics and performance of their medical device(s)
is(are) not adversely affected by transport or conditions of storage?
7
Product realization
7.1
Planning of product realization
The organization shall plan and develop
the processes needed for product
realization.
Planning of product realization shall be
consistent with the requirements of the
other processes of the quality management
system (see 4.1).
The organization shall establish
documented requirements for risk
management throughout product
realization. Records arising from risk
management shall be maintained (see
4.2.4).
32(4)(e) submit a quality plan with a
Class IV device application
9 Manufacturer's Obligations
32(4)(d) submit risk assessment with
Class IV device application
10 Manufacturer to perform risk
analysis
Does the Manufacturer have a quality plan (which is also submitted to Health
Canada with Class IV medical device applications) that specifies the processes
and resources for specific medical devices?
Have risk assessment and control measures been performed throughout the
product realization process for all classes of medical devices?
Note 1: See ISO 14971:2000 for guidance related to risk management.
Note 2: See GHTF SG3 guidance document "Risk Management as an Integral
Part of the Quality Management System" for additional guidance.
www.ghtf.org
7.2
Customer-related processes
7.2.1
Determination of requirements related to the product
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Checklist Section 2
ISO
13485
clause
Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
(re)cert.
The organization shall determine ...c)
statutory and regulated requirements
related to the product
7.3
Design and development
7.3.2
Design and development inputs
Inputs relating to product requirements
shall be determined and records
maintained (see 4.2.4). These inputs shall
include
a) functional, performance and safety
requirements, according to the intended
use,
b) applicable statutory and regulatory
requirements...
e) output(s) of risk management (see 7.1).
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2 to 5 Application
6 to 7 Classification
8 to 9 Application & Manufacturer's
Obligations
10 to 20 Safety and Effectiveness
21 to 23 Labelling
24 Contraceptive Devices Advertising
26 to 27 Prohibition
28 to 31 Medical Devices Deemed
Licensed
32 Application for a Medical device
Licence
34 Application for licence amendment
43 Obligation to inform
52 to 56 Distribution records
57, 58 Complaint handling
59 to 62 Mandatory problem reporting
63, 64 Recall
66 to 68 Implant registration
Schedule 1 Classification rules for
medical devices
Schedule 2 list of Implants that must
comply with the implant registration
requirements of section 66
Has the Manufacturer determined the applicable statutory and regulatory
requirements that apply to the medical device?
Did the Manufacturer use the Classification rules in Schedule 1 to classify any
new medical devices?
Does the Manufacturer track changes to the information and documents that
had been supplied earlier to Health Canada but did not lead to a licence
amendment? Are these changes reported during the annual licence renewal
process required in section 43(1) (b)?
Is the Manufacturer only selling licensed medical devices in Canada (see
www.mdall.ca)?
→ Refer to manufacturer’s MDALL listing to check the classification and
compare manufacturer’s identification in the licence and in the (draft)
certificate.
(Note: Objective evidence to satisfy this requirement will be found either at the
legal Manufacturers location or at another location that is part of the
Manufacturer's organization like a Canadian subsidiary that is controlled
through the organization's QMS. See [GD210] Annex C for auditing simple and
complex multi-site organizations)
10 Manufacturer to perform risk
analysis
11 Device must not adversely affect
the health or safety of a patient
13 Characteristics and performance of
device must not deteriorate under
normal use
14 The characteristics and
performance of a medical device shall
not be adversely affected by transport
or conditions of storage
15 Compatibility - Materials used the
manufacture of the device
16 Minimum risks to a patient and
other person from foreseeable hazards
18 Compatibility between parts and
components
19 Measuring function to perform
within tolerance limits
Has the Manufacturer determined the design and development inputs related to
the regulatory safety and effectiveness requirements?
Has the Manufacturer determined the medical device licensing requirements for
Class II, III or IV medical devices?
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ISO
13485
clause
Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
(re)cert.
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32 Application for a medical device
licence requirements
7.3.6
Design and development validation
As part of design and development
validation, the organization shall perform
clinical evaluations and/or evaluation of
performance of the medical device, as
required by national or regional regulations
12 device shall perform as intended
32(3)(f) and 32 (4)(i) : studies on
Class III and IV devices to ensure
safety and effectiveness
20 validation of software used in a
device
Has design and development validation been carried out and does the medical
device perform as intended ?
Has design and development validation been performed on initial production
medical devices or their equivalents?
Has the performance of any software used in the medical device been
validated?
7.3.7
Control of design and development
changes
1 MDR definition of a "significant
change"
Significant change means a change
that could reasonably be expected to
affect the safety or effectiveness of a
medical device… (a) the
manufacturing process, facility or
equipment; (b) the manufacturing
quality control procedures, including
the methods… to control the quality,
purity and sterility…; (c) the design of
the device…; and (d) the intended use
of the device, including … any change
to the period used to establish the
expiry date.
34 Application for a medical device
licence amendment for Class III or IV
device in the event of a "significant
change"
43(1)(b) Obligation to inform minister
at time of annual licence renewal of
any change to information or
documents that do not meet Section
34 requirements.
Does the Manufacturer have a process or procedure for identifying a "significant
change" to a Class III or IV medical device?
Does the Manufacturer have a procedure for amending a Class III or IV medical
device licence in the event of a significant change to a medical device?
Does the Manufacturer track changes to the information and documents that
had been supplied earlier to Health Canada but did not lead to a licence
amendment? Are these changes reported during the annual licence renewal
process required in section 43(1)(b)?
Following any design and development changes, is the device master file
(technical file) updated ?
→ Review the corresponding procedures and their application.
7.4
Purchasing
7.4.1
Purchasing process
The organization shall establish
documented procedures to ensure that
purchased product conforms to specified
purchase requirements. The type and
extent of control applied to the supplier and
the purchased product shall be dependent
upon the effect of the purchased product
No specific requirement in MDR.
Do Manufacturers who use suppliers to provide finished medical devices have
documented procedures in place to ensure that the finished medical device is
safe and effective?
Do Manufacturers who use suppliers to provide parts, components or services
that could affect the safety and effectiveness of the finished medical device
have documented procedures in place to ensure that the finished medical
device is safe and effective?
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Checklist Section 2
ISO
13485
clause
Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
(re)cert.
7.4.2
Purchasing information
Purchasing information shall describe the
product to be purchased, including where
appropriate .... quality management system
requirements.
7.5
Production and service provision
7.5.1
Control of production and service provision
7.5.1.1
General requirements
The organization shall plan and carry out
production and service provision under
controlled conditions.
No specific requirement in MDR.
7.5.1.2
Control of production and service provision - Specific requirements
7.5.1.3
Particular requirements for sterile
medical devices
7.5.2
Validation of processes for production and service provision
7.5.2.2
Particular requirements for sterile
medical devices
The organization shall establish
documented procedures for the validation
of sterilization processes. Sterilization
processes shall be validated prior to initial
use. Records of validation of each
sterilization process shall be maintained
(see 4.2.4).
7.5.3
Identification and traceability
7.5.3.2
Traceability
7.5.3.2
.1
General
The organization shall establish
documented procedures for traceability.
Such procedures shall define the extent of
product traceability and the records
required (see 4.2.4, 8.3 and 8.5). Where
traceability is a requirement, the
organization shall control and record the
unique identification of the product (see
17 Validation and control of
sterilization process
If the medical device is to be sold in a sterile condition, is it manufactured and
sterilized under appropriately controlled conditions, and is the sterilization
method used validated?
17 Validation and control of
sterilization process
17 Validation and control of
sterilization process
Does the Manufacturer have documented procedures for the validation of
sterilizations processes?
Was the sterilization process validated prior to initial use?
Does the Manufacturer have and maintain records of validation of each
sterilization process?
→ Review the objective evidence of appropriate manufacturer’s control
and validation of sterilization.
21 c) & d) Labelling
52 & 54 Distribution records
Do medical devices labels contain: a) the name of the medical device; b) the
name and address of the Manufacturer; c) the identifier of the medical device,
including the identifier of any medical device that is part of a system, test kit,
medical device group, medical device family or medical device group family; d)
in the case of a Class III or IV medical device, the control number?
→ Refer to the original wording of MDR sec. 21(1) to review the labelling!
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→ Also refer to clause 4.1 in this checklist!
on subsequent product realization or the
final product.
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Checklist Section 2
ISO
13485
clause
Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
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4.2.4).
The organization shall establish
documented procedures for traceability.
Such procedures shall define the extent of
product traceability and the records
required (see 4.2.4, 8.3 and 8.5). Where
traceability is a requirement, the
organization shall control and record the
unique identification of the product
52 to 56 Distribution Records
Do the Manufacturer's distributors have records of distribution of medical
devices and are these records kept for the longer of, the projected useful life of
the medical device as defined by the Manufacturer, or two years after the
medical device was shipped?
Do distribution records contain sufficient information to permit a complete and
rapid withdrawal of a Class II, III or IV medical device from the market?
Is the projected useful life of the medical device defined?
66 Implant registration (Applicable to
devices listed in Schedule 2 of the
MDR that are :
1. Heart valves
2. Annuloplasty rings
3. Active implantable device
systems
a. all models of implantable
pacemakers and leads;
b. all models of implantable
defibrillators and leads;
c. artificial heart;
d. implantable ventricular
support system; and
e. implantable drug infusion
system
4. Devices of human origin
a. human dura mater; and
b. wound covering
If the Manufacturer sells a medical device in Canada that is listed in Schedule 2
of the MDR, does the Manufacturer have procedures and records that satisfy
the traceability requirements of section 66?
→ Check the implant registration card’s contents against the requirement
of MDR sec. 66(1).
→ Check if the implant registration card provides for recording of the
information specified in MDR sec. 66(2)
→ Check if the implant registration card is available in both English and
French (MDR sec. 66(3))
7.5.3.2
.2
Particular requirements for active
implantable medical devices and
implantable medical devices
The organization shall require that its
agents or distributors maintain records of
the distribution of medical devices to allow
traceability and that such records are
available for inspection.... Records of the
name and address of the shipping package
consignee shall be maintained (see 4.2.4).
67(1) Implant registration
54(1),(2) Distribution records for
implants.
Do the Manufacturer's agents or distributors of active implantable and
implantable (as defined in section 3 of ISO 13485:2003) maintain distribution
records of these medical devices?
7.5.4
Customer property
The organization shall exercise care with
customer property while it is under the
organization's control or being used by the
organization. The organization shall
67(3) Implant registration
How does the Manufacturer safeguard the name and address of the patient,
unless disclosure is required by law?
758E9_A-CHECKLIST CMDCAS.DOC
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Revision: 0a / 2014-10-01
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Checklist Section 2
ISO
13485
clause
Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
(re)cert.
st
1
adv.
identify, verify, protect and safeguard
customer property provided for use or
incorporation into the product. If any
customer property is lost, damaged or
otherwise found to be unsuitable for use,
this shall be reported to the customer and
records maintained (see 4.2.4).
7.5.5
Preservation of product
The organization shall establish
documented procedures or documented
work instructions for preserving the
conformity of product during internal
processing and delivery to the intended
destination.
8
Measurement, analysis and improvement
8.2
Monitoring and measurement
8.2.1
Feedback
The organization shall establish a
documented procedure for a feedback
system [see 7.2.3 c)] to provide early
warning of quality problems and for input
into the corrective and preventive action
processes (see 8.5.2 and 8.5.3).
14 Conditions of storage and transport
57 (1)(a) Complaint Handling
Are the characteristics and performance of the medical device protected during
transport or storage, taking into account the Manufacturer's instructions and
information for transport and storage?
How does the manufacturer ensure such protection?
Does the Manufacturer and its Canadian importer and distributor(s) maintain
records of reported problems or consumer complaints relating to the
performance characteristics or safety of the medical device?
Are these problem reports or consumer complaints used as input into the
corrective action system?
Note 1 : for guidance on complaint handling and recall see http://www.hcsc.gc.ca/hpfb- dgpsa/inspectorate/medical _devices-eng.php
No specific requirement in MDR.
8.2.48.4
8.5
Improvement
8.5.1
General
The organization shall establish
documented procedures for the issue and
implementation of advisory notices. These
procedures shall be capable of being
implemented at any time.
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64 & 65 Recall
(note the MDR definition of Recall
includes the actions of physically
removing a device from the market or
notifying its owners and users of its
defectiveness or potential
defectiveness. See Section 1 of the
MDR for official definition)
58 a) Complaint Handling
59-62 Mandatory Problem Reporting
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Do the Manufacturer and his Canadian importer have documented procedures
for them to:
1. carry out an effective and timely recall of the medical device following
a consumer complaint or reported problem related to medical device
performance or safety;
2. recall or correct a medical device, or to notify its owners and users in
Canada of its defectiveness or potential defectiveness after becoming
aware that the medical device : (a) may be hazardous to health; (b)
may fail to conform to any claim made by the Manufacturer or importer
relating to its effectiveness, benefits, performance characteristics or
safety; or (c) may not meet the requirements of the Food and Drugs
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Checklist Section 2
ISO
13485
clause
Additional Guidance under GD210 and GD207
QMS requirement ISO 13485:2003
MDR requirement SOR/98 -282
Feb 26, 2006, consolidated
Auditor Considerations
Evaluation
(re)cert.
st
1
adv.
Act (R.S., c. F-27, s.1) or the MDR (SOR/DORS/98-282)
Note 3 : for guidance on Product recall procedures see http://www.hcsc.gc.ca/hpfb-dgpsa/inspectorate/ medical_devices-eng.php
Records of all customer complaint
investigations shall be maintained (see
4.2.4). If investigation determines that the
activities outside the organization
contributed to the customer complaint,
relevant information shall be exchanged
between the organizations involved (see
4.1).
If any customer complaint is not followed
by corrective and/or preventive action, the
reason shall be authorized (see 5.5.1) and
recorded (see 4.2.4).
57(1)(b) Maintain records of actions
taken following reported problems and
customer complaint.
Does the Manufacturer and its Canadian importer and distributors maintain
records of reported problems or consumer complaints relating to the
performance characteristics or safety of the medical device ?
Are these problem reports or consumer complaints used as input into the
corrective and preventive action system?
Note 1 : for guidance on complaint handling and recall see http://www.hcsc.gc.ca/hpfb-dgpsa/inspectorate/ medical_devices-eng.php
If national or regional regulations require
notification of adverse events that meet
specified reporting criteria, the organization
shall establish documented procedures to
notify the regulatory authorities.
Section 59 to 62: Mandatory Problem
Reporting
Does the Manufacturer and its Canadian importer have documented procedures
to inform Health Canada of incidents that meet the mandatory reporting criteria
found in Sections 59 to 62.
→ Refer to the original wording of MDR sec. 59-62 to review these
procedures.
Preliminary report within 10 (30) days after the manufacturer or his distributor
becomes aware of the incident, if the incident has (has not) to the death or serious
deterioration in the state of health of the patient, user, or other person
Note 2 : For guidance on mandatory problem reporting see http://www.hcsc.gc.ca/hpfb-dgpsa/inspectorate/ medical_devices-eng.php
8.5.2
Corrective action
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58 a), b) Complaint Handling
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See clause 8.5.1 of this checklist.
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