Canadian Medical Devices Conformity Assessment System(CMDCAS) - Training material

Canadian Medical
Devices Conformity
Assessment
System(CMDCAS) -
Training Material
Samantha Chen
(ASQ CQA)
chenshanshanresume@
gmail.com
Samantha Chen (2017-07-31)

Agenda
1
2
3
4
GD210: ISO 13485 Quality Management System Audits Performed by Health
Canada Recognized Registrars
GD207: Guidance on the Content of ISO 13485 Quality Management System
Certificates Issued by Health Canada Recognized Registrars
GD211: Guidance on the Content of Quality Management System Audit Reports
Objective
5 Specific Requirements from CMDR;
6 Transition to ISO 13485: 2016 & MDSAP;

Objective
– Understand the links between the CMDR
and ISO 13485 and thus gain an
understanding of how to incorporate the
former into your documented QMS;
– Learn what can be expected in an audit
performed by a Health Canada(HC)
Recognized Registrar.
– Learn what essential information that HC
requires to be displayed on ISO 13485
QMS certificate.
– Regarding the expectations for the
content of QMS audit reports, refer to
PowerPoint modules as well as video
training from CDRH learn portal.
– Specific Requirement from CMDR.
– Transition to ISO 13485: 2016 & MDSAP

Agenda
1
2
3
4
GD210: ISO 13485 Quality Management System Audits Performed by Health Canada
Recognized Registrars
Objective

Policy Statements
All QMS certificates issued by Health
Canada recognised registrars in support
of an application for, or the maintenance
of, a medical device licence pursuant to
the Regulations are to be based on a
certification procedure, including audits
that are documented in an audit report.
All such certification procedures, audits,
and audit reports are expected to meet
the requirements set out in ISO/IEC
17021:2006*, ISO 19011:2002*, and
Health Canada’s guidance documents
GD210 and GD211.

– ♦ CMDCAS
– Canadian Medical Devices Conformity Assessment System
– ♦ Certificate
– A CAN/CSA-ISO 13485:03 (or ISO 13485:2003) or CAN/CSA-ISO 13485:16 (or ISO 13485:2016)
quality management system certification document, issued by a Health Canada recognized
Registrar to be used by a Manufacturer for obtaining, maintaining, or amending a Health Canada
medical device licence. Certificates issued by a CMDCAS recognized Registrar will bear the SCC’s
mark of accreditation
– ♦ CMDCAS Recognized Register
– Registrars that are recognized by Health Canada through the accreditation and sector qualification
by the Standards Council of Canada (SCC).
– ♦ CMDR /MDR
– Canadian Medical Devices Regulations/Medical Devices Regulations
– ♦ MDSAP
– Medical Device Single Audit Program
–
Terms, Definitions, Acronyms Accreditation

1. BSI Group America Inc. (also operating under BSI Inc.)
2. DEKRA Certification B.V.
3. DQS Medizinprodukte GmbH
4. Intertek Testing Services NA Ltd., trading as Intertek
5. Laboratoire National de métrologie et d'Essais (LNE) - Division certification G-MED (trading as LNE/G-MED
and G-MED)
6. Lloyd's Register Quality Assurance Inc.
7. National Standards Authority of Ireland
8. SAI Global Certification Services Pty Ltd.
9. SGS United Kingdom Ltd.
10.Standards American Registrations Authority Registrar, Inc.
11.TÜV NORD CERT GmbH
12.TÜV Rheinland of North America, Inc.
13.TÜV SÜD America Inc.
14.TÜV USA, Inc.
15.UL LLC
CMDCAS-recognized certification
bodies

Background
 The CMDR requires Class II medical devices to be manufactured under
CAN/CSA ISO 13485 and Class III and IV devices to be designed and
manufactured under CAN/CSA-ISO 13485. There are no regulatory QMS
requirements for Class I medical devices.
 ISO 13485 recognizes that some requirements in Clause 7: Product
Realization may be “not applicable” due to the nature of the medical device.
For example, when a medical device does not require installation or post-
market servicing by the Manufacturer (clauses 7.5.1.2.2 and 7.5.1.2.3
respectively) then these clauses are to be omitted from the Manufacturer’s
quality manual but supported with details of the justification.
 Clause 4.1- General requirements, of ISO 13485 requires that the
Manufacturer ensures control over all outsourced processes and the control
shall be identified within the Manufacturer’s QMS.

 A CMDR requirement can be included in QMS documents in a number of ways. For
example, regulatory text or a summary of the text could be inserted into a procedure,
work instruction or some other relevant document.
 A CMDR requirement could be listed in
an annex to a general procedure,
or the section number of the
requirement could simply be referenced.
 Sample summary of CMDR requirements
and their applicability to manufacturers of
Class II, III and IV MD, importers, and distributors.
(details pls. refer to GD210,Annex B, Pg18)
Cross Reference for CMDR requirements in management
system documents

 The CMDR do not require foreign Manufacturers to have an “authorized contact” in
Canada. However, Canadian and foreign Manufacturers have the option of assigning
some activities like regulatory communication and record keeping to a Regulatory
Correspondent located in or out of Canada.
 Some of the activities that can be assigned to the Regulatory Correspondent include,
but are not limited to:
 licence renewal and voluntary withdrawal;
 responses to requests for additional information from Health Canada, including submission of QMS
documents and records related to post-market actions (mandatory problem reporting, complaints, recalls);
 maintenance of documentation and records related to the Manufacturer’s QMS (including design history file,
manufacturing specifications); or
 maintaining records and/or copies of licences (including information submitted to support a licence
application or amendment).
 Organizations that act as a Regulatory Correspondent and have been assigned specific regulatory activities by the
Manufacturer must be audited by the Health Canada Recognized Registrar. However, the audit might be
conducted through a documentation review, phone calls, or interviews, thus avoiding an actual on-site visit.
Regulatory Correspondent

• A Table that is based on the applicable CMDR requirements (details pls refer to
GD210, Annex A, Total 17 Pgs).
– Annex A Links between ISO 13485:2003 and the Medical Devices Regulations
Performing the Audit
The table in Annex A summarizes the links
between ISO 13485:2003 and the applicable
Part 1, MDR regulatory requirements that the
Manufacturer must meet.
They are intended for:
 providing confidence to Health Canada that Class II,
III and IV medical devices sold or distributed in Canada
consistently meet the safety and effectiveness
requirements;
 applying to Health Canada for a licence to sell or
distribute a medical device in Canada;
 maintaining objective evidence that demonstrate
that the medical device is safe and effective;
 retaining distribution records for traceability purposes;
documenting specified procedures;
 notifying Health Canada of defined changes to its
Manufacturing process or QMS certificate; and
 notifying users and Health Canada of medical device
problems or recalls. Samantha Chen (2017-07-31)

Agenda
1
2
3
4
GD210: ISO 13485 Quality Management System Audits Performed by Health
GD207: Guidance on the Content of ISO 13485 Quality Management System Certificates
Issued by Health Canada Recognized Registrars
Objective

– A Manufacturer will provide a valid CMDCAS certificate to Health Canada:
 to comply with sections 32(2)(f), 32(3)(j), 32(4)(p), and as applicable, 34 or 43.1 of the
Medical Devices Regulations (CMDR);
 as evidence of conformity with ISO 13485:2003 or ISO 13485:2016;
 as evidence of having documented and effectively implemented applicable sections of the
CMDR into your QMS; and,
 to indicate those devices that are designed and/or manufactured under the certified QMS.
– Extract from CMDR:
 Sections 32(2)(f)-- An application for a Class II medical device licence shall contain, in addition to the information and
documents set out in subsection (1), the following: a copy of the quality management system certificate certifying that
the quality management system under which the device is manufactured satisfies National Standard of Canada
CAN/CSA-ISO 13485:03, Medical devices — Quality management systems — Requirements for regulatory purposes.
 Sections 32(3)(j) - An application for a Class III medical device licence shall contain…same as above.
 Sections 32(4)(p) - An application for a Class IV medical device licence shall contain…same as above.
 Sections 34 - If the manufacturer proposes to make one or more of the following changes, the manufacturer shall
submit to the Minister, in a format established by the Minister, an application for a medical device licence amendment
including the information and documents set out in section 32 that are relevant to the change:
Background

– (a) in the case of a Class III or IV medical device, a significant change;
– (b) a change that would affect the class of the device;
– (c) a change in the name of the manufacturer;
– (d) a change in the name of the device;
– (e) a change in the identifier of the 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;
– (f) in the case of a Class II medical device other than a decorative contact lens, a change in the medical
conditions, purposes or uses for which the device is manufactured, sold or represented.
 Sections 43.1 - if a new or modified quality management system certificate is issued in respect of a
licensed medical device, the manufacturer of the device shall submit a copy of the certificate to the
Minister within 30 days after it is issued.
 The CMDR do not require importers or distributors of medical devices to have a certified QMS.
 Manufacturers of Class I devices that also design, manufacture and sell Class II, III or IV devices for
the Canadian market are eligible for certification under CMDCAS and may voluntarily include Class I
devices and other medical devices not sold in Canada in the audit process and in their QMS certificate
scope statement.
Background Cont.

Unique
Identification
Code
• The certificate shall bear a
unique identification code.
• The code is assigned by
the HC recognized
Registrar to reference a
unique certification.
• The code is limited to 30
characters (without
spaces).
Certificate Dates
• Health Canada requires
two dates to be displayed
on a certificate:
• effective date; and,
• expiry date or
recertification due date.
Manufacture's
Name
• The certificate’s main page
shall identify the name of
the Manufacturer to whom
the certification applies.
• The Manufacturer’s name
shall be the same as that
used on the medical device
licence and medical device
label.
• Name on the Certificate =
Name on the Licence = Name
on the Device Label
Content of a Certificate
The period specified by the
effective date and the
expiry or the recertification
due date shall not exceed
three years

Manu.,
Address
• Address on the Certificate = Address on the Licence = Address on the Device Label
• A complete address would include a street name and number, city, province or state,
postal or zip code, and country.
Multi-Site
QMS
• Multi-site organization, the names and street addresses of the branch offices shall
also be listed and identified as additional sites on the certificate, provided they are
covered by the certification. Additional addresses shall not confuse the main
address.
Scope
Statement
• The scope statement will contain “manufacture” or “design and manufacture”.
• Device listing shall be listed in the certificate’s scope statement using generic
device groups.
• (More Templates for Scope Statement pls. refer to GD207, Appendix 1, Pg14)
HC will not accept
”development "in place
of “design”.

Signing Authority:
A Certificate shall be signed and the authorized person’s name
and position shall appear below or beside the signature.
Registrar’s Name and Address
QMS Standard Audited Against
A certificate shall either reference CAN/CSA-ISO 13485:03 (or
ISO 13485:2003) or CAN/CSA-ISO 13485:16 (or ISO
13485:2016).
Record of Registrar’s Recognition
Make a claim on certificates that they are CMDCAS recognized.
Mark of Accreditation
Display the SCC’s mark of accreditation.
Format and Language
In printed hard copy, faxed or electronic formats. The certificate
shall be in English or French.
For example:
“DQS Medizinprodukte
GmbH is a CMDCAS recognized
Registrar”

 The implementation date of GD211 was January 1, 2012. Once implemented, all
audit reports prepared as part of certification procedures in support of an application
for, or the maintenance of, a medical device licence are expected to be prepared in
accordance with this.
 The purpose of this document is to provide guidance to Health Canada recognized
registrars on the expectations for the content of Quality Management System
(QMS) audit reports prepared as part of certification procedures in support of an
application for, or the maintenance of, a medical device licence.
 This guidance document will also be used as part of the US Food and Drug
Administration(FDA)’s Medical Devices ISO 13485 Voluntary Audit Report
Submission Pilot Program. As part of this cooperative endeavour, the FDA’s Centre
for Devices and Radiological Health (CDRH) and Health Canada’s Medical Devices
Bureau have developed publicly accessible training resources to assist auditors and
registrars in implementing this guidance document.
Background

– GD211: Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma
Presentation Presentation (French audio only)
– GD211: Module 1 - Introduction
– GD211: Module 2 - Information about the Manufacturer
– GD211: Module 3 - Information about the Audit
– GD211: Module 4 - Audit Findings
– GD211: Module 5 - Conclusions
Training Module for GD211
Or Pls refer to http://www.fda.gov/Training/CDRHLearn/default.htm to access the CDRH
learn portal. (under Postmarket Activities)

 Evidence-based decision making
 Individuals interviewed should be named or otherwise referenced;
 Report format
 Audit reports should be typed;
 Report Language
 Report should be in French or English, or be made available in either language upon request by the regulator;
 Identification of the Audit Team
 When interpreters are used, this should be mentioned in the report; Auditor should also mention languages
used informally to interview staff if these differ from the official languages of the audit.
 Company Identification Number(Company ID)
 Company ID number assigned by HC should be obtained from the MDALL website; if the company has no
licensed device, no Company ID number will exist, “N/A” or “not applicable” should be made;
 Audit dates format
 yyyy/mm/dd
Key information on Audit Report

– 4.5.2.2 Significant Change (GUI-0054)
– In the case of a Class III or IV device that has been subject to recall, an evaluation should be made to determine
whether the intended corrective action fits the definition of “significant change” (reference document written by MDB
(Medical Device Bureau)-Guidance for Industry - Guidance for the Interpretation of Significant Change of a Medical
Device). A statement of the results and rationale should be included in the written report of the recall required under
Section 65. If the corrective action fits the definition of “significant change” an application pursuant to an amended
medical device licence (Section 34(a) of the Regulations) must be submitted to the Medical Devices Bureau
describing the “significant change”. The amended license must be received before further sale of the device occurs.
Device Licence Amendment-
Significant Changes(Section 34)
Sections 34 - If the manufacturer proposes to make one or more of the following changes, the
manufacturer shall submit to the Minister, in a format established by the Minister, an application for a
medical device:
(a) in the case of a Class III or IV medical device, a significant change;
(b) a change that would affect the class of the device;
If the change is considered to be a Significant Change, as defined in the Medical Device Regulations and the
Guidance Document: Interpretation of Significant Change of a Medical Device (https://www.canada.ca/en/health-
canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-
document-interpretation-significant-change-medical-device.html), an application package should be assembled and
submitted to Health Canada.

Device Licence Administrative
Changes (Section 34)
Sections 34 - If the manufacturer proposes to make one or more of the following changes, the manufacturer
shall submit to the Minister, in a format established by the Minister, an application for a medical device:
(c) a change in the name of the manufacturer;
(d) a change in the name of the device;
(e) a change in the identifier of the 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;
(f) in the case of a Class II medical device other than a decorative contact lens, a change in the
medical conditions, purposes or uses for which the device is manufactured, sold or represented.
Device Name Change Fax back form
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
devices/application-information/forms/licence-amendment-form-guidance-changes-
name-device.html
Name and / or address of Manufacturer Fax back form
devices/application-information/forms/medical-devices-licence-amendment-back-form-
guidance-manufacturer.html and copy of revised ISO 13485 CMDCAS certificate
reflecting the change to Manufacturer’s name and / or address.
Non-significant addition / deletion / change to
device identifiers
Fax back form
devices/application-information/forms/medical-devices-licence-amendment-form-
guidance.html

Recall Notification Requirements
(Section 64)
4.5.1.11 Section 64 (k)
This section states:
(k) the name, title and telephone number of the representative of the manufacturer or importer to contact for
any information concerning the recall;
The representative should be easy to reach and aware of all developments concerning the recall. For Type I recalls
or as deemed necessary, the representative should be accessible on a 24 hour basis. A fax number or email
address should also be provided if available.(GUI-0054)
Section 64 of the Medical Devices Regulations requires the manufacturer and importer of a medical
device to provide Health Canada with information concerning a recall "on or before undertaking a
recall".
This is interpreted to mean that the manufacturer and importer must submit to Health Canada as
much recall information as is known within 24 hours of having made the decision to recall. This
initial notification may be made verbally or in writing. This must be followed within three
business days by a written report containing full information as required by section 64. Per section
65 of the Medical Devices Regulations, a report on the results of the recall and the action taken to
prevent a recurrence of the problem must be submitted as soon as possible after the completion of
a recall(Recall Policy POL-0016)

Mandatory Problem Reporting
Requirements (Section 60)
Section 60 (1) A preliminary report shall be submitted to the Minister
(a) in respect of an incident that occurs in Canada
• Within 10 days after the manufacturer or importer of a medical device becomes aware of an
incident, if the incident has led to the death or a serious deterioration in the state of health of a
patient, user or other person, or
• Within 30 days after the manufacturer or importer of a medical device becomes aware of an
incident, if the incident has not led to the death or a serious deterioration in the state of health of
a patient, user or other person, but could do so were it to recur;
60 (2) (h) the course of action, including an investigation, that the manufacturer or importer proposes
to follow in respect of the incident and a timetable for carrying out any proposed action and for
submitting a final report;

Agenda
1
2
3
4
GD210: ISO 13485:2003 Quality Management System Audits Performed by Health
Objective

REVISED VERSION OF ISO 13485
On March 1st, 2016, the International Organization for Standardization (ISO)
published the revised version of ISO 13485 titled “ISO 13485 – Medical Devices
– Quality management systems – Requirements for regulatory purposes”. This
revised version will supersede ISO 13485:2003. This revised standard is referred
to as ISO 13485:2016.
TRANSITION PERIOD
ISO will withdraw ISO 13485:2003 on March 1st, 2019, three years after the
publication of ISO 13485:2016.
Health Canada has set March 1st 2019, as the transition date to ISO
13485:2016. All manufacturers of class II, III, and IV medical devices holding
licences or applying for new or amended licences must complete the
transition to ISO 13485:2016 by March 1st, 2019.
Transition to the revised
version of ISO 13485

 The MDSAP Pilot is scheduled to run until December 31st, 2016. After the pilot ends, there
will be a two-year transition period.
 CMDCAS certificates will no longer be accepted after December 31st 2018. Manufacturers will
be required to submit valid MDSAP certificates by no later than January 1st, 2019 in order to
maintain their medical device licences. To facilitate a smooth transition, Health Canada is
encouraging manufacturers to begin the transition process in a timely matter to ensure
compliance with the regulatory requirements at the end of the transition period.
 As of January 1, 2019, only MDSAP certificates will be accepted.
Transition to MDSAP
Training Materials regarding MDSAP, Pls
refer to
http://fda.yorkcast.com/webcast/Play/ae
40c79d2479493393241d4a90e586691d
to access to the CDRH learn portal.

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