.../.../... (date)

For the competent authority,

(name and signature of responsible official)

( ^* )

Insert name of exporting or importing company or applicant authority

( ^** )

Insert competent authority and country name

( ^*** )

Delete unnecessary mention

1.

Purpose

1.1

Switzerland and Canada have developed this Sectoral Annex to the Mutual Recognition Agreement on the Assessment and Certification of the Conformity of Medical Devices with a view to strengthening bilateral cooperation in the Of the relevant regulations, while facilitating trade and maintaining the same stringent health and safety requirements in both jurisdictions.

1.2

In addition, this annex calls for the development of an infrastructure for ongoing communication/consultation between the regulatory and/or designating authorities and the conformity assessment bodies of each Party in order to Enable the regulatory authorities to establish and maintain the equivalence of their competence in the assessment of the conformity of medical devices and to adopt a joint approach in the field of vigilance after the Market.

2.

Scope of application

2.1

This Annex applies to all medical devices which, in Switzerland or in Canada, are subject to conformity assessment procedures, including technical and scientific assessments for high-risk medical devices and Quality system assessments conducted by a conformity assessment body.

2.2

The products concerned shall be determined by the law applicable in each Party, namely

(a)

For Switzerland

-

Federal Act of March 19, 1976 on the Safety of Technical Facilities and Devices (RS 819.1 );

-

Order of 24 January 1996 on medical devices (RS 819.124 ).

(b)

For Canada

-

Food and Drug Regulations and Medical Device Regulations and their subsequent amendments;

-

Canada's electricity code (to the extent it applies to medical devices);

-

The legislation and regulations on radiation emitting devices and their subsequent amendments (as they apply to medical devices).

Excluded from this Annex are:

-

In vitro diagnostic medical devices;

-

Devices incorporating a substance which, used separately, may be considered to be a drug;

-

Breast implants;

-

Medical devices incorporating tissues of human or animal origin. However, medical devices incorporating tissues of animal origin, when the device is designed to come into contact only with intact skin, are included within the scope of this Sectoral Annex.

The two Parties may, however, decide by mutual agreement to extend the application of this Annex to medical devices which were originally excluded from the scope during the transition period or the operational phase. The amendments to the scope will be listed in Annex 3.

3.

Confidentiality

3.1

Each Party shall protect against any disclosure of confidential technical, commercial and scientific information, including trade secrets and proprietary information obtained under this Agreement.

3.2

Subject to the provisions of subs. 3.1, each Party reserves the right to publish the results of any conformity assessment reports in cases where public health may be affected.

4.

Resolving differences of views

4.1

The differences of opinion that the regulatory authorities are unable to overcome are brought before the joint sectoral group to resolve them. If the latter cannot solve the problem, one of the Parties may refer the matter to the Joint Committee.

5.

Management Mechanism

5.1

A joint sectoral group shall be established for the management of this Sectoral Annex. Its tasks are to take decisions on the definition, establishment and evaluation of conformity assessment programmes and procedures, the implementation of the reciprocal alert programme, the management of the implementation period In confidence and in the definition of a program to maintain the mutual recognition agreement. The group consists of representatives from Health Canada and the Federal Office of Public Health and is co-chaired by a member of each Party.

6.

Transition period

6.1

Timing

The confidence building period begins with the signing of the Mutual Recognition Agreement and is expected to be completed within 18 months.

6.2

Confidence Building Program

At the beginning of the transitional period, the joint sectoral group shall draw up a joint confidence building programme (see the guidelines set out in Appendix 1). The implementation of this programme shall establish the capacity of each Party to conduct conformity assessments in accordance with the requirements and procedures of the other Party. The evidence has a practical impact on operational phase decisions.

The confidence building program should include the following actions and activities:

(a)

The organisation of seminars aimed at informing regulatory/designating authorities and conformity assessment bodies on the regulatory system, procedures and requirements of each Party;

(b)

Facilitation of workshops to help the regulatory/designating authorities to have a common understanding and to exchange information on the requirements and procedures for the designation and control of evaluation bodies Compliance;

(c)

For scientific technical assessments, an intercomparison exercise consisting of parallel (double blind) evaluations of the technical documents submitted by the manufacturer carried out by the conformity assessment body in each Territory in accordance with the requirements of the market to which the device in question is intended. Detailed reports and recommendations will be exchanged for comparison. The organisation responsible for the relevant market may issue a certificate of conformity during this intercomparison study. This study should be based on a sample of a sufficient number of cases covering the range of high-and medium-risk technologies and benefit from the participation of regulatory/designating authorities and agencies Conformity assessment of each Party. The Parties may require additional evidence of the competence of the regulatory/designating authorities or conformity assessment bodies;

(d)

For the evaluation of quality systems, an inter-comparison exercise consisting of involving the regulatory/designating authorities in audits carried out by the evaluation bodies of the other Party in accordance with the requirements of this Last. The management, methods and audit reports will be compared. The intercomparison study should be based on a sample consisting of a sufficient number of cases covering the range of different technologies and benefiting from the participation of regulatory/designating authorities and agencies Evaluation of each Party. The Parties may require additional evidence of the competence of the regulatory/designating authorities and conformity assessment bodies;

(e)

The design, development and testing of a reciprocal alert system (see guidance in Appendix 2);

(f)

The appointment of correspondents between the regulatory/designating authorities and the conformity assessment bodies of each Party;

(g)

Participation in information exchange meetings focusing on conformity assessment and vigilance, including participation in staff training sessions. Staff exchanges will also be encouraged; and

(h)

During the confidence building programme, where a Party finds that the evaluation methods and the results of the other Party are sufficiently reliable, it may, in a discretionary manner, establish the compliance document allowing access to the Market for its own jurisdiction solely on the basis of the evaluation reports of the other Party, without requiring the complete file.

Participation in the activities referred to in points (c) and (d) should be understood as a means of providing, for example, additional evidence on the process of designating and monitoring conformity assessment bodies.

6.3

Budget

Each Party to the Mutual Recognition Agreement shall be responsible for the costs of its participation in confidence-building activities.

6.4

End of transition period

The Joint Sectoral Group shall make a joint assessment of the experience gained 18 months after the entry into force of this Agreement. This assessment focuses on the quality of the confidence building program, as well as the jurisdictions of the regulatory/designating authorities and designated conformity assessment bodies.

On the basis of the results of the confidence-building programme/transition period, the Parties may decide by mutual agreement to extend the application of this Annex to medical devices which were originally excluded from the scope. The amendments to the scope will be listed in Annex 3.

The participating regulatory/designating authorities listed in Annex 1 are based on the results of the confidence building programme to recommend to the Joint Sectoral Committee the inclusion of conformity assessment bodies in the List of Annex 2 Conformity assessment bodies which have been accepted by the Joint Sectoral Group are listed in Annex 2, which also specifies their specific competence for conformity assessment and technologies Medical conditions for which they are recognized. Proposals to limit the recognition of the capacity of conformity assessment bodies should be based on objective and well-founded criteria. The Joint Sectoral Group may recommend that a conformity assessment body not be included in Annex 2, provided that it produces documentary evidence of its incapacity. Excluded conformity assessment bodies may request a review of their situation as soon as the necessary corrective measures have been taken and confirmed.

Where the Joint Sectoral Group is unable to agree on any of the above, the matter shall be referred to the Joint Committee in accordance with the Agreement.

The Parties shall enter the operational phase as long as Annex 2 includes conformity assessment bodies of each Party.

The Agreement shall also be reviewed at the end of the transitional period in order to take into account the evolution of the regulations of each Party. A single procedure for application, conformity assessment and evaluation of quality systems meeting the requirements of each jurisdiction will be considered.

7.

Operational Phase

7.1

General obligations

The provisions of this Section shall apply to conformity assessments carried out on the respective territories of the Parties by conformity assessment bodies recognised in accordance with this Sectoral Annex.

Conformity assessments carried out in the respective territories of the Parties by conformity assessment bodies recognised in the framework of Mutual Recognition Agreements concluded by either Party with a third country Will be recognized as long as:

(a)

Each Party recognizes the competence of conformity assessment bodies;

(b)

The certificate (s) provided by the conformity assessment bodies identifies the conformity assessment procedures it has assessed; and

(c)

The conformity assessment bodies and their respective regulatory/designating authorities undertake to comply with the provisions laid down in the reciprocal alert programme of this Annex.

In accordance with the above conditions, scientific technical assessments of high-risk medical devices may be carried out outside the territory of the Parties.

Switzerland and Canada agree that, for the medical devices covered by this Annex, each Party shall recognise the findings of the conformity assessments carried out by the other Party and the certificates of conformity issued by The conformity assessment body of the other Party, refraining from carrying out any further assessment.

For evaluations conducted in accordance with Swiss requirements, Health Canada, conformity assessment bodies designated by Canada or another conformity assessment body recognized as competent by Switzerland shall establish the Conclusions of conformity assessments in accordance with the provisions of the Swiss Ordinance concerning medical devices and issues the appropriate certificate of conformity. The Federal Office of Public Health accepts, without any further assessment, certification as evidence of compliance with the pre-market requirements laid down in the Swiss Ordinance on Medical Devices.

For evaluations conducted in accordance with Canadian requirements, conformity assessment bodies designated by Switzerland or other conformity assessment bodies recognized as competent by Canada shall establish the Conclusions of the evaluation and submit to Health Canada an abbreviated report and a certificate of compliance incorporating these findings. Based on these documents, and without any further assessment, Health Canada accepts the certification as evidence of compliance with the pre-market requirements set out in the Canadian Medical Devices Regulations.

Upon reasoned request, the Parties shall notify each other of the information checked in the evaluation of a medical device for the purpose of establishing certificates of conformity.

Each Party reserves the right, at any time, to challenge the information relating to the designation process or the conduct of conformity assessments in accordance with its regulatory provisions. In addition, each Party reserves the right to conduct its own conformity assessments for the reasons given to the other Party. The verifications shall be notified in advance to the other Party and shall be carried out jointly by the regulatory/designating authorities of both Parties. Such audits will be based on written rationales. The evaluation reports will be shared with the other Party and the issues or corrective measures will be discussed and resolved jointly. The use of such audits remains exceptional.

The Parties may, by mutual agreement, extend the application of this Annex to medical devices which were originally excluded from the scope of application during the operational phase. The amendments to this scope will be listed in Annex 3.

7.2

Procedures for designating conformity assessment bodies

The procedures applied by the competent authorities of each Party to designate conformity assessment bodies shall comply with the criteria laid down in the regulations or guidelines of the other Party (see Non-binding guidelines set out in Appendix 3).

7.3

Exchange of information

In accordance with the general provisions of the Annex, the Parties shall exchange all information necessary for the establishment and maintenance of the equivalence of conformity assessment procedures. In addition, Parties shall communicate the information generated by their respective regulatory systems of interest to conformity assessment procedures (i.e. guidance documents, reference publications). Standards, forms, documents relating to the application of the legal provisions). Each Party shall involve the regulatory/designating authorities and the conformity assessment bodies of the other Party in the exchange of information and sharing of experience.

In special cases, in particular in emergency situations, the bodies involved in the implementation of this Annex shall endeavour to provide, as soon as possible, the documents requested by one of the Parties.

7.4

Reciprocal Alert System

The Joint Sectoral Group shall ensure that an effective mutual warning system is operational at all times. The components of this system are described in Appendix 2.

The Parties shall notify each other of any confirmed problems, corrective actions or recalls concerning products which they have evaluated in accordance with the provisions of this Agreement. Each Party shall respond to special requests for information on a given medical device and shall ensure that its designated authorities and conformity assessment bodies provide the requested information.

The Swiss and Canadian regulatory authorities shall ensure that any suspension or cancellation (total or partial) of a certificate of conformity is notified immediately to the other regulatory authorities.

7.5

Fees

The system of conformity assessment and certification fees is determined by the place of manufacture. Cost recovery programs and fees for the establishment of certificates of compliance for each jurisdiction fall within their jurisdiction. The Parties shall not claim conformity assessment fees to manufacturers established in the territory of the other Party, where conformity assessment has been carried out by a conformity assessment body located on the territory of the Party Of that other Party.

7.6

Follow-up to the Agreement

The permanent monitoring of the equivalency of the appointment processes and the conformity assessments of each Party judged to be equivalent to the term of the confidence building programme and any subsequent decisions concerning such equivalence shall be Consistent with the implementation and maintenance of equivalence developed and managed jointly. These activities are managed by the Joint Sectoral Group.

The Parties undertake to consult regularly, within the Joint Sectoral Group established under this Annex, in order to ensure the relevance and accuracy of this Annex. Regulatory/designating authorities and conformity assessment bodies organise meetings to discuss specific issues and problems.

Conformity assessment bodies and regulatory/designating authorities shall continue to participate in the equivalence activities provided for by the Joint Sectoral Group in the context of this Annex, in order to Continue to appear in Appendix 2.

Parties may request that conformity assessment bodies be included in Annex 2. New conformity assessment bodies shall be accepted in accordance with the procedure described in the confidence building programme. The inclusion of conformity assessment bodies in Annex 2 shall be the subject of a decision of the Joint Sectoral Group taken on the recommendation of a regulatory/designating authority.

7.7

Correspondents

Correspondents are designated to allow regulatory authorities and manufacturers to inform the regulatory authorities of the other Party with due diligence of quality defects, recalls and incidents that may Require additional checks, suspension of the distribution of the product or suspension or cancellation of a certificate of conformity.

For the purposes of this Annex, the correspondents are:

For Switzerland:

Federal Office of Public Health;

And

For Canada:

Therapeutic Products Directorate, Health Canada.

8.

Appendices and Appendices

Annexes 1, 2 and 3 are an integral part of this Sectoral Annex. Appendices 1, 2 and 3 are general guidelines.

For conformity assessment bodies designated by Switzerland

For conformity assessment bodies designated by Canada

Federal Office of Public Health

Therapeutic Products Programme, Health Canada

For Switzerland

For Canada

To be specified at the end of the confidence building program

To be specified at the end of the confidence building program

1.

Purpose

The purpose of this Sectoral Annex is to establish a framework for the acceptance of test reports and, upon the expiry of a transitional period, certificates of conformity issued in the territory of a Party in accordance with the Provisions of the other, as specified in Annex 1.

2.

Scope of application

2.1

The provisions of this Annex apply to the following types of telecommunications terminal equipment, radio transmitters and information processing equipment:

(a)

Equipment intended to be connected to the public telecommunications network ¹ For the transmission, processing or receipt of information, whether designed to be directly connected to the termination of the network or to interoperate with the network by being connected directly or indirectly to its point Of termination. The connection can be made by wire, radio, optical or any other electromagnetic means;

(b)

Equipment that can be connected to a public telecommunications network even if it is not their primary destination, including information processing equipment with a communication port;

(c)

The categories of radio transmitters defined and specified in Annex 2.

2.2

A non-exhaustive list of the interfaces and services covered by each Party is provided in Annex 2.

2.3

The Parties agree that the following list is an indicative and non-exhaustive list of the categories of radio transmitters covered:

(a)

Short-range devices, including low-power devices such as cordless telephones/microphones;

(b)

Devices for terrestrial mobile communications, including:

-

Private mobile radiotelephony (PMR/PAMR);

-

Mobile telecommunications;

-

People's research systems;

(c)

Fixed terrestrial communications devices;

(d)

Devices for mobile satellite communications;

(e)

Fixed satellite communications devices;

(f)

Broadcasting devices;

(g)

Radio tracking devices.

3.

Technical provisions

3.1

This Sectoral Annex applies to all compulsory licensing provisions adopted in the territory of the Parties by public organisations or bodies which are legally entitled to impose technical rules, for equipment The corresponding technical requirements shall be specified in the legislation referred to in Annex 1.

3.2

All conformity assessment provisions and procedures applicable to domestic products shall be applied as is, without any other condition or change, to the products or results of conformity assessment From the other Party.

4.

Conformity Assessment Activities

4.1

Both Parties declare that their conformity assessment bodies, recognised in this Sectoral Annex, are authorised to carry out the following activities relating to their respective technical provisions concerning equipment Telecommunications terminals, radio transmitters and information processing equipment:

(a)

In connection with the connection of terminals and radio transmission: testing, publication and acceptance of test reports, completion of the technical evaluation required and certification of conformity with the legislative provisions and Regulations applicable in the territories of the Parties to the products covered by this Sectoral Annex;

(b)

In the field of electromagnetic compatibility: mutual recognition of certificates of conformity, declarations of suppliers and technical manufacturing files, if necessary. Detailed provisions are set out in the Sectoral Annex on Electromagnetic Compatibility;

(c)

In the field of electrical safety/low voltage: acceptance of tests and certifications of conformity of products covered by the provisions of the other Party relating to electrical safety. The detailed provisions are set out in the sectoral annex on electrical safety;

(d)

Quality management certificates: recognition of a Party's quality management certificates in accordance with the regulatory provisions of the other Party.

4.2

Certificates of conformity and approval issued by conformity assessment bodies designated by one of the Parties under the provisions of this Sectoral Annex shall be recognised by the authorities of the other Party without any other Product evaluation.

5.

Institutions

5.1

Designating authorities

(a)

"Designating authorities" means the authorities and organisations responsible for designating conformity assessment bodies and for ensuring their competence in the testing and certification of conformity of equipment covered by the This Annex in accordance with the provisions of the other Party. For the purposes of this Annex, they are listed in Annex 3. To carry out these tasks, they may seek the services of their accreditation system.

(b)

The Parties shall inform themselves within ten working days of any change in their designation authorities and their obligations under this Sectoral Annex.

5.2

Designated Conformity Assessment Bodies

(a)

For the purposes of this Sectoral Annex, each Party shall designate competent bodies to assess compliance with the provisions of the other Party. Each Party shall ensure that designated organizations meet the criteria and standards set out in the regulatory provisions of the other Party. By making designations, the Parties shall indicate the products and procedures for which the bodies have been designated. A list of designated organizations, with the indication of the products and procedures for which they have been accredited, is provided in Appendix 4.

(b)

The conformity assessment bodies designated in this Sectoral Annex shall be recognised as competent to carry out the activities for which they have been designated.

(c)

The designation, suspension or revocation of conformity assessment bodies under this Sectoral Annex shall be carried out in accordance with the procedures established by the Joint Committee established in the context of this Agreement.

(d)

In the event of a complaint or in any other circumstances involving the ability of a conformity assessment body to carry out its tasks in accordance with this Sectoral Annex, the competent appointing authority shall be required to To intervene in the mutual satisfaction of the Parties. If necessary, the Joint Committee established by this Agreement may examine these problems in order to arrive at a solution.

6.

Transitional provisions

6.1

A transition period of eighteen months is foreseen before the provisions of this Annex, in particular those in Section 4, become fully operational.

6.2

This transitional period shall enable the Parties to:

(a)

Exchange information on their respective regulatory provisions and improve their understanding;

(b)

Develop common mechanisms for the exchange of information on changes in technical rules or methods of designating conformity assessment bodies;

(c)

Monitor and evaluate the work performed by designated conformity assessment bodies during the transition period.

6.3

During the transition period, the Parties shall also mutually recognize the test reports and related documents issued by their designated conformity assessment bodies in accordance with the provisions of this Annex. Sector. For this purpose, the approval authorities listed in Annex 5 shall accept, for approval purposes, the test reports and related documents as well as evaluations from the designated bodies located in the territory of the other Party Without imposing any other conditions and ensure that:

(a)

Upon receipt of the test reports, related documents and a first conformity assessment, it is quickly verified that the files are complete;

(b)

The applicant is informed of any deficiencies in a precise and complete manner;

(c)

Any request for additional information is limited to omissions, contradictions or discrepancies in relation to standards or technical rules;

(d)

The procedures applied to equipment modified after a conformity assessment are limited to those which are necessary to verify that they are still in conformity;

(e)

The conformity assessment provisions and procedures applied to domestic products shall be applied as is, without any other condition or change, to products or conformity assessment results from The other Party.

6.4

The approval authorities undertake to issue approvals or to inform applicants no later than six weeks after receipt of the test report and evaluation from a designated body in the territory of the other Party.

6.5

At the end of the transitional period, the Parties shall proceed to the mutual recognition of all certificates of conformity and approvals issued by the designated bodies of the other Party. Any proposal during or after the transition period to limit the scope of recognition of a conformity assessment body or to exclude it from the list of bodies designated in this Sectoral Annex Based on objective and well-founded criteria. The body concerned may request a review of its situation as soon as the necessary corrective measures have been taken. To the extent possible, the Parties shall implement these measures before the expiry of the transitional period.

7.

Additional provisions

Outsourcing

7.1

Any subcontracted activity must be carried out in accordance with the subcontracting provisions of the other Party.

7.2

Conformity assessment bodies shall record all elements of investigations relating to the competence and conformity of their subcontractors and shall keep a register of all subcontracted activities. Such information shall, on request, be made available to the other Party.

Post-market surveillance

7.3

For the purpose of post-market surveillance, Parties may retain existing labelling and numbering provisions. The latter may take place in the territory of the exporting Party. The numbers are assigned by the importing Party.

7.4

Where the misuse of a mark of conformity occurs or where there is a risk of a product covered by this Sectoral Annex, both Parties shall jointly determine the scope of the abuse and the nature and Degree of corrective action to be taken.

Joint Telecommunications Group

7.5

The Joint Committee set up in the context of the Mutual Recognition Framework Agreement may appoint a Joint Telecommunications Group, which shall meet, if necessary, to consider technical, technological or conformity assessment issues Relating to this Sectoral Annex.

Exchange of information and mutual assistance

7.6

Each Party shall appoint one correspondent to respond to all justified requests by the other Party concerning procedures, regulations and complaints.

7.7

As provided for in the transitional provisions set out in section 6.2 above, the Parties may, during the first year of the transition period, jointly sponsor two seminars on technical requirements and Licensing provisions for affected products, one in Switzerland and one in Canada.

7.8

The Parties shall also inform themselves of the amendments to the applicable regulations, specifications, test methods, standards and administrative procedures within 30 working days of their internal notification.

Regulatory Amendments and Updates to the Annex

7.9

In the event of amendments to the regulations referred to in Annex 1 or the introduction of new regulations concerning conformity assessment procedures in either Party, this Sectoral Annex shall be updated.

Cross reference

7.10

If products covered by this Annex are also subject to electrical safety or electromagnetic compatibility requirements, the corresponding provisions of the relevant Sectoral Annexes shall also apply.

Switzerland

Canada

Telecommunications Act of 30 April 1997 (CTA); (RS 784.10 )

Ordinance of 6 October 1997 on telecommunications facilities (ILO); (RS 784.101.2 )

Electromagnetic compatibility order of 9 April 1997; (RS 734.5 )

Order of 9 April 1997 on low-voltage electrical equipment; (RS 734.26 )

Order of the Federal Communications Office (OFCOM) of 9 December 1997 on telecommunications facilities; (RS 784.101.21 )

Annex to the OFCOM Ordinance on Telecommunication Facilities specifying the Swiss regulations with regard to:

(a)

Telecommunications terminal equipment and equipment for terrestrial satellite communications stations, harmonised, based on the decisions of the European Commission taken pursuant to Directive 91 /263/EEC supplemented by the Directive 93 /97/EEC and amended by Directive 93 /68/EEC

(b)

Radio transmitters and non-harmonised telecommunications facilities (civil application; equipment for ground stations for satellite communications included) subject to conformity assessment procedure. A list of the relevant technical standards is contained in Appendix 1, let. (b)

Manual on the implementation of Directive 91 /263/EEC (approved by ADLNB and ACT).

Telecommunications Act

Radiocommunication Act

Telecom Decision CRTC n ^O 82-14

SH-03 Certification Specification

Certification Procedure PH-01

Radiocommunication Regulations

Radio Standards Procedure (NRP) n ^O 100: certification procedure for radio equipment

Canada's Electrical Code

Terminal Equipment List

Radio Equipment List

List of Standards for Licensed Radio Equipment

List of Radio Equipment Standards Exempt from a Broadcasting Certificate

List of Standards for Category I Equipment

List of Standards for Category II Equipment

Switzerland

Canada

In specific terms, this Annex covers the following interfaces and services:

Basic access to ISDN

Primary Access to ISDN

ISDN Telephony

Access X21/V. 24/V. 35

X25 Access

Non-voice PSTN

ONP leased line terminals of type:

-64 kbits/s-2048 kbits/s unstructured-2048 kbits/s structured-access in 34 Mbits/s-access in 140 Mbits/s-2 yarns, analog-4 yarns, analog

Analog connections not harmonized with public switched telecommunications networks. For technical specifications (see appendix 1, let. (b)

All telecommunications installations and all radio transmitters include the equipment of terrestrial satellite communication stations for civil application subject to Swiss telecommunications regulations (see appendix 1, let. (b)

In specific terms, this Annex covers the following interfaces and services:

Basic access to ISDN

Primary Access to ISDN

X.21 Access

X.25 Access

Digital Services Access:

-1.2 kbits/s-2.4 kbits/s-9.6 kbits/s-4.8 kbits/s-19.2 kbits/s-56 kbits/s-64 kbits/s-1544 kbits/s-45 Mbits/s

2-Wire Analog/Analog Lines

4-Wire Analog/Analog Lines

Analog connections to public switched telecommunications networks

All civil application issuers subject to the Radio Regulations (see Appendix 1, let. (a)

Definition of a radio transmitter:

"Radio transmitter" means any radio frequency apparatus or association of apparatus intended or capable of being used for the transmission or transmission of signs, signals, texts, images, sounds or information of any kind to the Medium of electromagnetic waves, of a frequency greater than 9 kHz and less than 3000 GHz, propagated in space without artificial guide. This Annex covers only radio transmitters for civil application.

Definition of a radio transmitter:

"Radio transmitter" means any radio frequency apparatus or association of apparatus intended or capable of being used for the transmission or transmission of signs, signals, texts, images, sounds or information of any kind to the Medium of electromagnetic waves, of a frequency greater than 9 kHz and less than 3000 GHz, propagated in space without artificial guide. This Annex covers only radio transmitters for civil application.

Switzerland

Canada

Federal Communications Office for Telecommunications Terminal Equipment, Terrestrial Satellite Communications Equipment and Radio Transmitters

Federal Office of Energy for Electrical Safety and Electromagnetic Compatibility

Industry Canada for Terminals, Radio Transmitters and Electromagnetic Compatibility

Standards Council of Canada for Electrical Safety

Standards Council of Canada for Registrars of Quality Systems

Switzerland

Canada

Federal Communications Office

Industry Canada

Standard

Called

Editing

Date

CNR-117

Terrestrial or coastal station transmitters A1, A2, A3, A2H or A3H operating in the band 200 to 535 kHz

2

30 March 1974

CNR-118

Basic station and subscriber base station radio transmitters and receivers with voice frequencies (data signals or tones) operating in the cellular mobile bands between 824-849 MHz and 869-894 Mhz

2

Note 1

19 August 1990

Addendum to standard RSS-118

1

1 ^Er Seven. 1990

Annex A of standard RSS-118

Standard for compatibility between mobile stations and ground stations of cellular systems

22 Oct. 1983

RSS-118 Modified

Change-2nd Edition

24 August 1996

CNR-119

Terrestrial and fixed radio transmitters and receivers, 27.41 to 960 Mhz

5

24 August 1996

CNR-123

Licensed low-power radio devices

1 Provisional

Feb 24, 1996

CNR-125

Terrestrial and fixed radio transmitters and receivers, 1.705 to 50.0 MHz, using mainly modulated amplitude modulation

2

24 August 1996

CNR-128

Dual-mode cellular phones running in the 800 Mhz Telephones band

1 Provisional

12 June 1993

RSS-128 Modified

Amendment

24 August 1996

CNR-129

Dual-mode AMRC Cellular Telephones in the 800 MHz Band

1 Provisional

Feb 24, 1996

RSS-129 Modified

Amendment

24 August 1996

CNR-130

Digital Cordless Telephones in the Band 944 to 948.5 MHz

2

Jan 23, 1993

Annex 1 to RSS-130

#Annexe 1-CT2Plus, Class 2: Standards for the Canadian Common Hertzienne Interface for Digital Cordless Telephony, including Utilities

2

Jan 23, 1993

Appendix 1 to RSS-130

European Telecommunications Standards Institute Interim Standard /I-ETS 300 131

April 1992

CNR-131

Radio signal enhancers for mobile telephone service

1 Provisional

Feb 24, 1996

CNR-133

Personal Communications Services in the 2 GHz Band

1 Provisional

Nov 29, 1997

CNR-134

Narrowband personal communications service in the 900 MHz band

1 Provisional

24 August 1996

CNR-135

Digital Scanning Receivers

1 Provisional

Oct. 26. 1996

CNR-136

Land station and mobile station transmitters and receivers operating in the band 26.960 to 27.410 MHz of the general radio service

5

1 ^Er Jan 1977

CNR-137

Location and Control Services in the 902-928 MHz Band

1 Provisional

Nov 29, 1997

CNR-181

Single side band radio transmitters and receivers of coast station and ship station operating in the band from 1605 to 28 000 kHz

1

1 ^Er April 1971

Change RSS-181

This amendment contains some clarifications regarding RSS-181

1 ^Er Jul. 1987

CNR-182

Marine radiotelephone devices with frequency or phase modulation operating in the band 156 to 162.5 MHz

2 Note 1

Dec 2. 1989

CNR-187

Emergency Locator Beacons, Emergency Beacons, and Personal Locator Beacons

3

24 August 1996

CNR-188

Global Maritime Distress and Safety System (GMDSS)

1 Provisional

24 August 1996

CNR-210

Low-power, licence-exempt radiocommunication devices

2

Feb 24, 1996

*Supplement 1993-1

Supplement 1993-1 to Radio Standards Specifications (RSS) 118 and 182

12 June 1993

Standard

Called

Editing

Date

NTMR-1

Standards and Technical Requirements for Transmitter of Low Power Advertisements in the Frequency Bands 525 to 1 705 kHz and 88 to 107.5 MHz

1

1 ^Er Nov 1996

NTMR-3

Standards and Technical Requirements for Broadcasting Equipment Part of a Collective Antenna Television Broadcasting Undertaking (MATV)

1

1 ^Er Nov 1996

NTMR-4

Technical Standards and Requirements for Television Broadcasting Transmitters

1

1 ^Er Nov 1996

NTMR-5

Standards and Technical Requirements for AM Broadcasting Transmitters

1

1 ^Er Nov 1996

NTMR-6

Standards and Technical Requirements for FM Broadcasting Transmitters

1

1 ^Er Nov 1996

NTMR-8

Technical standards and requirements for FM transmitters operating in small, remote communities

1

1 ^Er Nov 1996

NTMR-9

Technical standards and requirements for television transmitters operating in small, remote communities

1

1 ^Er Nov 1996

NTMR-10

Technical standards and requirements for television transmitters operating in the band 2 596-2 686 MHz

1

1 ^Er Nov 1996

NTMR-11

Technical Requirements for the Identification of Broadcasting Stations

1

1 ^Er Nov 1996

Standard

Called

Editing

Date

NER-1-1

Radio broadcast standards: broadcasting AM stereophonic exploitation

1 Provisional

Feb 6, 1988

NER-1-2

Broadcast Emission Standards: AM Broadcasting RF Emission Limits

1 Provisional

Nov. 1989

NER-3

Broadcasting Emission Standards: Television Broadcasting

2

May 1990

CR-14

Broadcasting charges: videotex provisional broadcast

1 Provisional

19 June 1981

Technical Standard

Called ¹

Editing

Date

1.1

Technical specifications for radiotelephony facilities operating in the 27 MHz band (FM/4 W).

3

1 ^Er June 1996

1.2

Technical specifications for radio-telephony installations operating in the 27 MHz (AM 1 W/SSB 4 W) band.

4

1 ^Er June 1996

1.3

Technical specifications for the terrestrial mobile radiotelephony facilities operating in the 30 MHz to 1000 MHz band, which have an internal or external HF connection and are primarily used for analog voice transmission.

3

1 ^Er Jan 1996

1.6

Technical specifications for low-range radio equipment for transmission of data or speech and operating in the band 9 kHz to 25 MHz (electromagnetic) and 9 kHz to 30 MHz (inductive) on frequencies Collective.

3

1 ^Er Jul. 1995

1.15

Technical specifications for data radiocommunication installations operating in the 30 MHz to 1000 MHz of land mobile service on exclusive or common frequencies.

3

1 ^Er Seven. 1997

1.16

Technical specifications for microwave radiocommunication installations operating with a small number of channels in the 1.5 GHz band.

2

1 ^Er Jan 1995

1.17

Technical specifications for microwave radiocommunication installations operating in the band from 23 GHz to 38 GHz.

2

1 ^Er Jan 1995

1.19

Technical specifications for low-range radio equipment for transmission of data or speech and operating in the 25 MHz to 1000 MHz band on collective frequencies.

2

1 ^Er Jan 1995

1.20

Technical specifications for on-site personnel search systems, operating on collective frequencies, in the band 16 kHz to 150 kHz (inductive facilities) or in the 25 MHz band at 470 MHz (HF facilities).

2

1 ^Er Jan 1995

1.24

Technical specifications for base stations operating in the ERMES (European Radio Message System) radio network.

2

1 ^Er Jan 1995

Technical Standard

Called

Editing

Date

1.26

Technical specifications for microwave radiocommunication installations operating in the 10 GHz band.

1

1 ^Er Jan 1995

1.27

Technical specifications for the aerial interfaces of CT1 + wireless phones.

1

1 ^Er Jan 1995

1.28

Technical specifications for the aerial interfaces of CT2 wireless phones.

1

1 ^Er Jan 1995

1.29

Technical specifications for radio-telephony facilities with integrated air service in the 30 MHz to 1000 MHz band, primarily intended for analog transmission of speech.

1

1 ^Er Jul. 1995

1.30

Technical specifications for broadband audio installations.

1

1 ^Er June 1996

1.32

Technical specifications for wireless microphones operating in the 25 MHz to 3 GHz band.

1

1 ^Er June 1996

1.33

Technical specifications for low-range radiocommunication facilities operating on collective frequencies in the 1 GHz band at 25 GHz.

1

1 ^Er June 1996

2.2

Technical specifications for wireline installations: PSTN connection.

1

1 ^Er Jul. 1995

2.4

Technical specifications for wireline facilities: PSTN, voice telephony service, voice terminal equipment.

1

1 ^Er Jul. 1995

Technical Standard

Called

Editing

Date

337/1.3

Provisional technical specifications for radio apparatus operating on 406.025 MHz for the "Emergency Position Indicating Radio Beacons (EPIRBs)" (Base: ETS 300 066)

2

1 ^Er May 1995

337/1.5

Provisional technical specifications for radio apparatus operating on 121.5 MHz and 243 MHz for "Emergency Position Indicating Radio Beacons (EPIRBs)" (Base: ETS 300 152)

2

1 ^Er Jan 1995

337/1.7

Provisional technical specifications for local networks of wireless enterprises (RLANs) operating on 2.4 GHz, 5.2 GHz and 17.2 GHz operating for the CDMA broadband data systems (Base: ETS 300 328)

2

1 ^Er Jan 1995

337/1.11

Provisional technical specifications for VSAT transmitters/receivers, for data communications and operating at 11 GHz, 12 GHz and 14 GHz (Base: ETS 300 159)

2

1 ^Er Jan 1995

337/1.16

Provisional technical specifications for mobile satellite radio apparatus for data communications for low flows and operating at 11 GHz, 12 GHz and 14 GHz (Base: ETS 300 255)

2

1 ^Er Jan 1995

337/1.17

Provisional technical specifications for mobile satellite radio apparatus for data communications for low flows and operating at 1.5 GHz and 1.6 GHz (Base: ETS 300 254)

2

1 ^Er Jan 1995

337/1.18

Provisional technical specifications for portable mobile installations for video-reporting

1

1 ^Er Seven. 1995

337/1.19

Provisional technical specifications for microwave installations in the 1.5 GHz frequency range

1

22 May 1995

337/1.20

Provisional Specifications for Hertzian Beam Installations in the 58 GHz Frequency Range (Base: prTE 300 408)

1

6 March 1995

337/1.22

Provisional technical specifications for microwave installations in the 7 GHz frequency range (Base: ETS 300 234)

2

15 May 1996

337/1.23

Provisional technical specifications for mobile radio apparatus, operating for the Terrestrial Flight Telecommunication System (TFTS) (Base: ETS 300 326-2)

1

15 August 1995

337/1.24

Provisional technical specifications for terrestrial satellite stations operating for the "Satellite News Gathering (SNG)" in frequency ranges 13-14 GHz and 11-12 GHz (Base: ETS 300 327)

1

15 May 1996

337/1.25

Provisional technical specifications for mobile earth stations operating at 1.5 GHz and 1.6 GHz for transmission of the track and data (Base: ETS 300 423)

1

15 May 1996

337/1.26

Provisional technical specifications for maritime mobile radiotelephony installations operating in the medium and shortwave (Base: ETS 300 373)

1

1 ^Er April 1997

337/1.27

Provisional technical specifications for <Repeater> operating in microwave networks in the 1.5 GHz frequency band

1

19 May 1997

337/1.28

Provisional technical specifications for GSM and DCS1800 base stations (Base: I-ETS 300 609-1)

1

1 ^Er Dec. 1997

337/1.29

Interim technical specifications for ground stations in the aeronautical mobile service used in the VHF band (118 MHz-137 MHz) with amplitude modulation and channel spacing of 8.33 kHz (Base: ETS 300 676)

1

1 ^Er Dec. 1997

337/2.2

Provisional technical specifications for user installations: PSTN connection (Base: TBR 21)

1

Dec 22 1997

786.6/prTA 1.34

Interim Technical Specifications for GSM (Phase 2 and 2 +) transmitters (Base: ETS 300 609-4)

1

1 ^Er August 1998

786.6/prTA 1.38

Interim Technical Specifications for Frequency Modulated VHF Transmitters (Base: ETS 300 384)

1

15 June 1998

1.

Scope of application

1.1

The provisions of this Annex shall apply to:

(a)

Electromagnetic compatibility of equipment within the meaning of the electromagnetic compatibility (OCEM) order of 9 April 1997; (RS 734.5 );

(b)

Electromagnetic compatibility of equipment covered by the Canadian Radio Communications Act.

2.

Requirements

2.1

The corresponding technical requirements are specified in the legislative and regulatory provisions set out in Annex 1.

2.2

All conformity assessment requirements and procedures applied by a Party to its domestic products shall be applied as is, without any other condition or change, to the products or the results of assessments of the Compliance from the other Party.

3.

Conformity Assessment

3.1

The Parties agree to recognize all reports, certificates and technical records of manufacture of the other Party required by their respective legislation without further assessment of the products.

3.2

The Parties agree to mutually recognise suppliers' declarations of conformity in accordance with their respective legislation.

4.

Institutions

4.1

Designating authorities

(a)

The designating authorities for the purposes of this Annex are listed in Annex 2;

(b)

The Parties shall inform themselves within ten working days of any change in their designation authorities and their obligations under this Sectoral Annex.

4.2

Designated Conformity Assessment Bodies

(a)

Conformity assessment bodies designated in this Annex shall be recognised as competent to carry out conformity assessment activities in the field of electromagnetic compatibility. Each Party shall ensure that designated organizations meet the criteria and standards set out in the regulatory provisions of the other Party. A list of designated organizations is provided in Appendix 3;

(b)

The designation, suspension or revocation of conformity assessment bodies under this Sectoral Annex shall be carried out in accordance with the procedures established by the Joint Committee established in the context of the Recognition Agreement Mutual.

5.

Transitional provisions

5.1

The provisions of this Annex with regard to mutual recognition, in particular section 3 thereof, shall take effect within 18 months of the entry into force of this Agreement.

5.2

Between the signing of the Agreement and its entry into force, the Parties shall cooperate to:

(a)

Become familiar with their respective regulatory provisions;

(b)

Exchange information and verify the work done by the designated conformity assessment bodies, and

(c)

Demonstrate to their mutual satisfaction their ability to assess compliance under the provisions of the other Party.

6.

Additional provisions

Outsourcing

6.1

Any sub-contracted conformity assessment shall be carried out in accordance with the subcontracting provisions of the other Party.

6.2

Conformity assessment bodies shall record all elements of investigations relating to the competence and conformity of their subcontractors and shall keep a register of all subcontracted activities. Upon request, such information shall be made available to the other Party without delay.

Post-market surveillance

6.3

For the purpose of post-market surveillance, Parties may adopt labelling, marking or numbering provisions. Labelling, marking and numbering may take place in the territory of the exporting Party.

Exchange of information and mutual assistance

6.4

Each Party shall appoint one correspondent to respond to all justified requests by the other Party concerning procedures, regulations and complaints.

6.5

The Parties shall also inform themselves of the amendments to the relevant regulations, specifications, test methods, standards and administrative procedures within 30 working days of their internal notification.

Regulatory amendments and updates to the schedule

6.6

In the event of amendments to the technical regulations and conformity assessment procedures specified in Annex 1 or in the event of the introduction of new regulations in the territory of one of the Parties, this Sectoral Annex shall be updated.

Cross reference

6.7

If products covered by this Annex are also subject to electrical safety or connection requirements for radio or telecommunications equipment, the corresponding provisions of the Sectoral Annexes Concerning electrical safety, telecommunications terminal equipment, information processing equipment and radio transmitters also apply.

Switzerland

Canada

Electromagnetic Compatibility (EMC) Order of 9 April 1997; (RS 734.5 )

Swiss regulations for radio transmitters (civil applications) submitted to the Telecommunications Act of 30 April 1997 (CTA); (RS 784.10 )

Radiocommunication Act

Radiocommunication Regulations (below list of standards for radio transmitters under Canadian Radio Regulations)

List of Standards for Category II Equipment

Standard

Called

Editing

Date

NMB-001

Industrial, Scientific and Medical Radio Frequency Generators

2

13 August 1994

NMB-002

Spark ignition systems of vehicles and other devices equipped with an internal combustion engine

2

NMB-003

Digital Devices

3

Nov 22, 1997

NMB-004

High voltage ac power networks

1

June 1991

Switzerland

Canada

Federal Office of Energy

Industry Canada

1.

Purpose

1.1

The purpose of this Sectoral Annex is to establish a framework for the acceptance of electrical products by the recognition of conformity assessments carried out by bodies complying with the requirements of the other Party, while at the same time Preserving the integrity of the security system of each Party.

1.2

This Annex also defines the procedures for recognition:

(a)

Conformity assessment bodies (ECAs) in Canada by Switzerland, and

(b)

Conformity assessment bodies in Switzerland by Canada.

2.

Scope of application

2.1

For access to Switzerland: the safety of electrical equipment falling within the scope of the order of 9 April 1997 on low-voltage electrical equipment (OMBT) ¹ ; (RS 734.26 ).

2.2

For access to Canada: low voltage electrical equipment, including medical devices, covered by the Canadian electricity code, with the exception of products specifically excluded by OMBT (other than medical devices).

2.3

The legislative, regulatory and administrative provisions applicable in each Party and the regulatory authorities responsible for electrical safety are listed in Annex 1.

3.

Responsible Authorities/Designations

3.1

The authorities listed in Annex 2 shall be the organisations or public authorities responsible for ensuring and verifying the competence of conformity assessment bodies for electrical equipment in their territory in accordance with the provisions Of the other Party.

4.

Transition Phase

4.1

Transitional provisions shall be applied for a period of eighteen months from the entry into force of this Agreement.

4.2

The objective of this transitional phase is to enable the responsible/designating authorities to better understand their respective systems and to strengthen their mutual confidence in their procedures for the recognition of Compliance and their ability to carry out their missions. The proper implementation of the transitional provisions should enable the responsible authorities to conclude that the bodies mentioned meet the applicable criteria and have the necessary competencies to carry out evaluation activities of the Acceptable compliance by the other Party.

4.3

During the transitional phase, the authorities may jointly sponsor two seminars on technical requirements and licensing provisions, one in Switzerland and the other in Canada.

5.

Progress of the transitional phase

5.1

During the transition phase, Canadian conformity assessment bodies will accept test reports and related documents issued by the designated agencies of the other Party. The Swiss conformity assessment bodies must meet the following requirements:

(a)

Be part of the IECEE system of the International Electrotechnical Commission (IEC) for the recognition of the results of tests of conformity to the safety standards of electrical equipment (certification body system (CB) in the framework The IEC system of tests for the safety of electrical equipment (IECEE) as defined in document 02 /1992-05 of the IECEE, or

(b)

Have entered into an agreement to accept test results with a certification body accredited by the Standards Council of Canada.

5.2

During the transitional phase, the Swiss conformity assessment bodies shall:

(a)

Test products in accordance with Canadian provisions;

(b)

Prepare a comprehensive trial and evaluation dossier (including data and reports) that the manufacturer of the tested products submits to a certification body in Canada.

5.3

Canadian certification bodies ensure that:

(a)

Inform the applicant and the conformity assessment body of Switzerland of any inadequacy in a precise and complete manner;

(b)

Limit any request for additional information or samples to omissions, contradictions or discrepancies with respect to technical regulations or standards, and

(c)

To carry out the certification on the basis of the existing procedures, in particular as regards the affixing of their mark.

6.

Compliance mark

6.1

During the transition phase, the Joint Committee shall develop mutually acceptable mechanisms and procedures for the marking of products to be exported to Canada to indicate their compliance with Canadian provisions. These marks shall be affixed under the supervision of conformity assessment bodies recognised by the responsible/designating authorities; they enable the traceability of products, provide sufficient information to consumers and Do not cause confusion with other compliance marks. For access to the Swiss market, the provisions of the OMBT apply.

7.

Operational Phase

7.1

During the operational phase, the Parties shall complete the mutual recognition of the results of conformity assessment procedures in accordance with their respective legislation. Conformity assessment bodies recognised by the responsible/designating authorities shall operate as follows:

(a)

For access to the Swiss market:

If the conformity of a product is contested by the Swiss authorities, a report prepared by a Canadian conformity assessment body recognised under this Agreement shall be assimilated by Switzerland to a report by a Swiss OEC Recognized under the provisions of the WTO;

(b)

For access to the Canadian market:

The conformity assessment bodies of Switzerland shall be accredited in accordance with the criteria of the Standards Council of Canada governing the accreditation of recognized certification bodies in Canada and shall be issued a certificate Certification. The following conditions are deemed to be equivalent to the prescribed criteria:

(i)

Evidence of satisfactory operation during the transitional phase;

(ii)

Accreditation by the Swiss Accreditation Service (SAS) according to the applicable ISO/IEC guides adapted to the Swiss and Canadian requirements for accreditation of certification bodies, and

(iii)

Existence of procedures for monitoring certification activities, including the designation of a correspondent to intervene with the manufacturers of the products, if applicable.

7.2

The Parties shall encourage the conclusion of a Mutual Recognition Agreement between the SAS (or European Accreditation-EA) and the SCC.

7.3

Following the entry into force of the operational phase, the inclusion of additional conformity assessment bodies shall be carried out in accordance with the rules laid down in the Agreement.

8.

Limiting or denying recognition for certification purposes

8.1

Upon request, a conformity assessment body may be requested to produce additional supporting documents in order to facilitate its transition from the transitional phase to the operational phase.

8.2

During or at the end of the transitional period, any proposal inviting, in accordance with the procedures described in the Framework Agreement, the responsible/designating authority to limit the recognition of a designated conformity assessment body or To exclude it from the list of accredited/designated bodies shall be objectively substantiated, duly documented and submitted in writing to the Joint Committee.

8.3

The conformity assessment body to which limited recognition has been granted or has been excluded may request a re-evaluation as soon as corrective measures have been taken.

9.

Monitoring Certification Activities

9.1

The authorities of each Party (see annexes 1 and 2) reserve the right to challenge the performance of conformity assessment bodies whose activities fall within the scope of this Annex. On reasoned request, the authorities of a Party may obtain a copy of the certification report drawn up in accordance with their requirements in the territory of the exporting Party. This report will be provided promptly and without charge.

9.2

Conformity assessment bodies and their customers put in place an action plan to remove non-compliant or dangerous products from the market. This plan designates a correspondent to intervene with the manufacturers of the products in question.

10.

Joint Group on Electrical Safety

10.1

The Joint Committee established under the Mutual Recognition Agreement shall establish a joint group on electrical safety.

10.2

This group is composed of an equal number of representatives from Switzerland and Canada.

10.3

The group may examine issues of concern to either Party. No Party shall refuse a request for review by the other Party.

10.4

The group may make recommendations to the Joint Committee on issues raised by the representatives of Switzerland or Canada.

10.5

The group shall adopt its own rules of procedure, take its decisions and adopt its recommendations by consensus of the Parties.

Switzerland

Canada

Order of 9 April 1997 on low-voltage electrical equipment (OMBT); (RS 734.26 ),

Federal Office of Energy

The Canadian Electricity Code under provincial/territorial legislation is the responsibility of the following provincial/territorial regulatory authorities:

Alberta:

The Safety Codes Act,

Statutes of Alberta, 1991, Chapter S-0.5;

Alberta Department of Labour, Technical and Safety Services

British Columbia:

Electrical Safety Act, Chapter 109

Electrical Safety Regulation,

B.C. Reg 253/96

Ministry of Municipal Affairs & Housing

Manitoba:

Manitoba Hydro Act, 1976

Provincial Regulation 126-94, as amended in September 1995

Manitoba Hydro

New Brunswick:

Electrical Installation and Inspection Act

General Regulation 84-165

Regulation 82-215 on lightning protection devices

Ministry of Higher Education and Labour

Newfoundland:

Public Safety Act

Electrical Regulations, 1996

Department of Government Services and Lands

Northwest Territories:

The Electricity Hazards Protection Act,

L. R.T.N-O 1988, C.E-3

Department of Public Works and Services

Nova Scotia:

The Electrical Installation and Inspection Act

Nova Scotia Department of Labour

Ontario:

Electricity Corporation Act,

Revised Statutes of Ontario, 1990,

Chapter P18, Section III

Ontario Regulation 612-94

Hydro-Ontario

Prince Edward Island:

The Electrical Inspection Act

The Electrical Inspection Act Regulations

Department of Community Affairs and Attorney General

Quebec:

Electrical Facilities Act, R.S.Q., Chapter I-13.01

Electrical Facilities Regulations, I-13.01, R. 3

Quebec Electricity Code

Régie du bâtiment du Québec

Saskatchewan:

The Electrical Inspection Act, 1993

Electrical Inspection Regulations

Saskpower

Yukon:

The Electricity Hazards Protection Act

Order 1992-017 Yukon Electricity Protection Act Regulations

Yukon Department of Community and Transportation Services

Switzerland

Canada

Federal Office of Energy

Standards Council of Canada, a federal agency established by an Act of the Parliament of Canada in 1970 as amended in 1996.