. /.WORLD TRADE
ORGANIZATIONG/TBT/N/CAN/47
16 October 2002
(02-5610)
Committee on Technical Barriers to Trade Original: English/
French
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   CANADA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Department of Health
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:  Canadian Enquiry
Point, 200-270 Albert Street, Ottawa, Ontario, Canada, K1P 6N7 Tel.:  +1 613 238 3222,
Fax.: +1 613 569 7808, E-mail: info@scc.ca
          
3. Notified under Article 2.9.2 [     ], 2.10.1 [    ], 5.6.2 [ X  ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Medical devices
(ICS: 03.120.01, 11.040.01)
5. Title, number of pages and language(s) of the notified document:  Proposed
Amendments to the Medical Devices Regulations (1293 - Quality systems) (English and
French, pages 3021-3028)
6.Description of content:
The Medical Devices Regulations  were promulgated in July 1998.  Because of the
complexity and magnitude of the work that needed to be done to implement some of the
requirements of the Regulations, Part 5 of the Medical Devices Regulations  contained
transitional provisions and delayed the coming into force dates of certain requirements
including quality systems requirements which were delayed to July 1, 2001.  As July 1,2001, approached, Health Canada decided that more time was needed to prepare for the
implementation of the quality system requirements and requested an amendment to delay
the coming into force date of the  requirements to January 1, 2003.  Health Canada
anticipated that the 18-month period between July 1, 2001, and January 1, 2003, would
serve as a transition phase whereby manufacturers of Class II, III and IV devices wouldhave an opportunity to increase th eir ability to comply with the Medical Devices
Regulations by January 1, 2003.  Health Canada also saw the 18-month period as an
opportunity for manufacturers of Class II, III and IV devices to voluntarily submit valid ISO
13485 or ISO 13488 quality management system certificates to Health Canada before such
certificates become mandatory under the Regulations on January 1, 2003.The proposed amendments pertain to the quality system requirements contained in sections
32 and 43 of the Medical Devices Regulations .G/TBT/N/CAN/47
Page 2
These proposed amendments require that:
- the organization that performs the audit of the manufacturer’s quality system be a
quality system registrar, who is recognized by the Minister of Health as having the
necessary training, experience and technical knowledge in the design and
manufacture of medical devices and in the effective implementation of qualitysystems to determine whether a quality system satisfies the applicable standards
referred to above, and conducts quality system audits in accordance with the
applicable guidelines and  practices established by the International Organization
for Standardization (ISO);
- the registrar, upon completing a satisfactory quality system audit, issues, to the
manufacturer, a quality system certificate, which will be valid for a maximum of
three years;
- the manufacturer, when applying for a medical device licence, submit a copy of its
quality system certificate to the Minister, to demonstrate that its device is in
compliance with the above-stated standards;
- the manufacturer submit a copy of a new quality system certificate before the three-
year expiry date of the certificate previously submitted to the Minister;
- the manufacturer submit a copy of a new or modified quality-system certificate
within 30 days of its issuance, when one is issued before the expiration date of the
one previously submitted to the Minister, for example, addition of a manufacturing
site to the original facility scope;
- if a quality system certificate is suspended or cancelled for whatever reason by the
registrar who issued it, the registrar notify Health Canada within 15 days of the
suspension or cancellation;
- manufacturers who already have medical devices licences on January 1, 2003,
submit a quality system certificate for their licenced medical devices before
November 2003, as  part of their annual update to the documents and informationthat they supplied with respect to their devices as required  under section 43 of the
Medical Devices Regulations , entitled the “Obligation to Inform” section.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of human safety
8. Relevant documents:  Canada Gazette, Part I, 5 October 2002
9. Proposed date of adoption:  not stated
Proposed date of entry into force:  1 January 2003
10. Final date for comments:   19 December 2002
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
The electronic version of the regulatory text can be downloaded at:
http://canada.gc.ca/gazette/part1/pdf/g1-13640.pdf