Presented by : Yi-Chang Tsai ( [email protected]) April 23-24, 2003Current Regulatory Approach for...

April 23-24, 2003 Current Regulatory Approach for IT products of Chinese Taipei

Slide 1

Presented by : Yi-Chang Tsai ([email protected])

WTO ITA

Current Regulatory Approach for

Information Technology Products of

the Separate Customs Territory of

Taiwan, Penghu, Kinmen and Matsu


Slide 2

Presentation Overview

• Regulatory Agencies of IT Products

• A Brief Introduction to BSMI’s Authority

• Regulatory Overview

• Accreditation Body

• Conformity Assessment Body

• MRA Case Study

• Conclusion


Slide 3

Regulator

Our Geographic Location

* Map from http://go.hrw.com/atlas/norm_htm/asia.htm


Slide 4

Regulator

The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu

* Map from http://go.hrw.com/atlas/norm_htm/taiwan.htm


Slide 5

Regulatory Agencies

BSMI

Ministry of Econominic Affairs

DGT

Ministry of Transportation and Communications

Executive Yuan

IT Products Government Agencies Organization Structure


Slide 6

Regulatory AgenciesInformation Technology (IT) Products’ Governmental Agencies in “the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu”(hereafter called “Chinese Taipei”) – Directorate General of Telecommunications

(DGT)– telecommunications equipment

– Bureau of Standards, Metrology and Inspection (BSMI)　

– computers, semiconductors, semiconductor manufacturing equipment, software and scientific instruments


Slide 7

Regulatory Agencies (continued)

• IT Products DGT Contact Persons– Mr. Hsi-Lan Hsu Tel: +886-2-2343-3650

Email: [email protected]

– Mr. Yi-Chang Tsai Tel: +886-2-2343-3836


Fax: +886-2-2343-3699

• IT Products BSMI Contact Person– Mr. Bing-Yuan Liou Tel: +886-2-2343-1906

Fax: +886-2-3343-3991


Current Regulatory Approach for IT products of Chinese Taipei

April 23-24, 2003

A Brief Introduction to BSMI’s Authority

• Designating Authority: Bureau of Standards, Metrology

and Inspection (BSMI), Ministry of Economic Affairs

Chinese Taipei’s Regulatory Regime for Information Technology Equipment (ITE ) (Excluding Radio & Telecommunications

Terminal Equipment (R&TTE))


April 23-24, 2003

Legal Basis

Our Primary Regulation:

Commodity Inspection Act

– The competent authority as referred to in this Act shall be the Ministry of Economic Affairs

– The Bureau of Standards, Metrology and Inspection (the BSMI) is in charge of commodity inspection operations

.quarantine


April 23-24, 2003

EMC Inspection Implementation

Commodities announced as subject to EMC inspection include:– Copy machines effective January 1, 1997

– TVs, VCRs, fax machines, and ITEs (Information Technology Equipment)

effective January 1, 1998

– Household appliances, power tools, audio products, computer components effective July 1, 2000

– Other products are also being considered to be placed under EMC control.


April 23-24, 2003

EMC Inspection Standards

• CNS 13803 (CISPR 11)– industrial, scientific and medical equipment

• CNS 13439 ( CISPR 13)– audio, TV and VCR equipment

• CNS 13783-1 ( CISPR 14)– household products

• CNS 13438 (CISPR 22)– ITE and peripherals

• CNS 14115 (CISPR 15)– lighting products

CNS = Chinese National Standards


April 23-24, 2003

Technical Requirements of ITE

• Chinese Taipei has mandatory technical requirements for electromagnetic interference of ITE.

• Required to meet the requirements of CNS 13438 (harmonized with CISPR 22)

• No mandatory technical requirements for electromagnetic immunity of ITE


April 23-24, 2003

Inspection Scheme

Batch-by-Batch Inspection– For commodities of a fixed type, the BSMI may

require a type approval certificate before application for simplified inspection procedure

– Test sample products on a batch basis (with 5~20% probability)

– Compliance document issued if the sampled products pass testing

– Products can be shipped or imported and be placed on the market


April 23-24, 2003

Inspection Scheme (Cont.)

Registration of Product Certification (RPC)

– Ensuring the continued compliance of the regulations for that product

– Reducing the trade impact from border controls

– Subjecting product to type testing and certification

– Including conformity assessment procedures, in the designing and manufacturing stages


April 23-24, 2003


Registration of Product Certification (Cont.)

– After obtaining the registration of certification for the tested type of product, products can be shipped or imported and be placed on the market

– Certificate is valid for 3 years

– RPC Inspection Mark is shown below:

R3A001


April 23-24, 2003


Declaration of Conformity (DoC)

– The obligatory applicant shall prepare relevant technical documents to ensure that the commodity conforms to the inspection standards and shall, based on such technical documents, execute and issue a declaration of conformity.

– The obligatory applicant shall keep the declaration of conformity and relevant technical documents for a given period of time for possible future verification.


April 23-24, 2003


Declaration of Conformity (Cont.)

– The testing shall be conducted by the BSMI or a BSMI approved designated testing laboratory

– DoC Inspection Mark is shown below:

D3A001


April 23-24, 2003

The Technical Information and Documents that Comply with EMC Requirements

Descriptions of Commodities:– User Manuals and Specifications written in

Chinese (User manuals written in English are also acceptable for Class A Products);

– Block Diagrams;– Table or list of the EMC components and

emission sources; and– Product catalogue and a 4" x 6" or larger

color photo of both the outer appearance and interior structure.


April 23-24, 2003

The Technical Information and Documents that Comply with EMC (Cont.)

One original test report issued within one year by the designated laboratory, before proceeding the declaration of conformity.


April 23-24, 2003

Testing Facilities

• Accreditation requirements for testing facilities are based on ISO/IEC 17025.

• The BSMI has designated 31 internal EMC testing laboratories.

• In addition, there are over 100 foreign EMC testing laboratories designated by the BSMI.

• Please refer to the BSMI website for the details about the designated laboratories.


April 23-24, 2003

DoC Experience

• Planning the products apply to DoC: – have a short life cycle

– are stable and have low safety risks

– create little impact on consumers, such as the components

• Starting with a small range of products to test the knowledge and cooperation of manufacturers, importers and distributors have to meet the certification regulations for their products.


April 23-24, 2003

DoC Experience (Cont.)

• On January 18, 2002, it was announced that 19 commodity items were to be applicable to the DoC procedures.

• Included are electric calculators, data storage units, class B computer mainboards, add-on cards with I/O, and power supplies.

• Although in this first stage of DoC about 30% of products are not complying with the regulations, we believe that more guidance will help reduce this figure.


April 23-24, 2003

DoC Experience (Cont.)

• During this period, the government and consumers must bear considerable risk.

• However, to establish complete management over the post-market surveillance is one of Chinese Taipei’s most important goals.


April 23-24, 2003

Further Information

• BSMI Website http://www.bsmi.gov.tw

• For more information, please contact: Mr. Bing-Yuan Liou Tel: +886-2-2343-1906 Email: [email protected]


Slide 25

Regulatory Overview

The Telecommunications Act

The Statute of Chunghwa Telecom Co., Ltd.

The Organizational Statute of

Directorate General of Telecommunications

Legislated: Jan. 16, 1996 Enforced: Feb. 5, 1996

Telecom Act Revised: Oct. 10, 2002

Legal Basis for Telecom Reform & Liberalization

Three Telecommunications Laws


Slide 26

Regulatory Overview

Key Points of the Telecommunications Act– defining Type I and Type II telecom enterprises;

– specifying the deregulation mechanism for Type I and Type II telecom enterprises;

– providing equal network access by prohibiting cross-subsidies and mandating universal service obligations;

– stipulating that those telecom enterprises should provide fair and non-discriminatory services;

– imposing competitive safeguard clauses to control anti-competitive behavior;


Slide 27

Regulatory Overview

Key Points of the Telecommunications Act (continued)– amending the provisions of radio spectrum

management; and

– stipulating that telecom equipment should obtain compliance approval.


Slide 28

Regulatory Overview

Equipment Approval Related Articles of the Telecom Act

(2002 Telecommunications Act)– §39 Network Equipment General Requirements

– §42 TTE General Requirements

– §44 TTE Approval Authority

– §46 Station (Radio & Cable) General Requirements

– §48 ISM Equipment General Requirements

– §49 & 50 Controlled Radio Equipment General Requirements


Slide 29

Classification of Equipment for Approval

Equipment ResponsibleDepartment

Contact Person

Telecom TerminalEquipment (TTE)

& Low-Power RadioFrequency Devices

Chief EngineerOffice

Mr. Hsi-Lan HsuTel: +886-2-2343-3650Fax: +886-2-2343-3699Email: [email protected]. Yi-Chang TsaiTel: +886-2-2343-3836Fax: +886-2-2343-3699Email: [email protected]

Mobile Base Station& Microwave

Public TelecomDepartment

Mr. Gin-Shian LouTel: +886-2-2343-3627Fax: +886-2-2343-3600Email: [email protected]

Amateur RadioEquipment

Dedicated TelecomDepartment

Mr. Gi-Kai ChangTel: +886-2-2343-3796Fax: +886-2-2343-3784Email: [email protected]


Slide 30

Conformity Assessment Schema

Designating Authority/Regulator [DGT]

Testing Lab Accreditation Body

[CNLA]Comply with ISO/IEC Guide 58

Testing LaboratoriesComply with ISO/IEC Guide 25

Certification BodiesComply with ISO/IEC Guide 25 &

65

CABs

Certification Accreditation Body

[CNAB]Comply with ISO/IEC Guide 61

RCBs


Slide 31

Designating/Regulatory Authority

DGT is the Designating & Regulatory Authority for Telecommunications,

EMC and Electrical Safety of Telecommunications Equipment.– Verify the Competence of Conformity

Assessment Bodies (CABs)– Designate CABs– Withdraw Designation– Reinstate Designation


Slide 32

Accreditation Body

Accreditation Body: Chinese National Laboratory Accreditation (CNLA)– Tests laboratory accreditation body– To improve the standard of operation of

accredited facilities and streamline the MRA CABs designating procedures, DGT accredited and designated CNLA as the Telecom MRA testing lab accreditation body with the ISO/IEC Guide 58 in December 1998.


Slide 33

Accreditation Body

Accreditation Body: Chinese National Accreditation Board (CNAB)– Recognized Certification Body (RCB)

Accreditation Body– To streamline the MRA designating

procedures , DGT appointed CNAB as accreditation body of the Telecom MRA Recognized Conformity body with ISO/IEC Guide 61 in November 2001.


Slide 34

Testing Labs Designation Criteria

• Legal entities which have the technical competence to perform the tests

• Accredited with ISO/IEC Guide 25, EN45001 or CNS12608 (Chinese National Standard)

• Demonstration of technical competence in performing the tests

• Technological knowledge and experience with relevant product

• Familiar with related legislative, regulatory and administrative provisions


Slide 35

Designation Process

• Submission of Application Package to CNLA

• Accreditation of Testing Lab by CNLA

• Submission of the Accredited and Recognized Testing Lab List to DGT


Slide 36

Recognized Testing Labs in Chinese Taipei

• Telecommunication Laboratories, Chunghwa Telecom Co., Ltd.

• Electronics Testing Center, Taiwan

• Training Research Co., Ltd.

• Taiwan Tokin EMC ENG. Corp.

• Global EMC Standard Tech. Corp.

• QuieTex Corporation

• Neutron Engineering Inc.

• C & C Laboratory Co., Ltd.

• Advance Data Technology, Ltd. • http://www.dgt.gov.tw/English/Type-approval/8.1/lab-tw-

3661.shtml


Slide 37

RCB Designation Criteria

• Non-government legal entities

• Neither act as an importer, designer, manufacturer or supplier of telecommunications equipment nor be engaged in these activities

• Equipment certification system should meet the requirements and conditions of ISO/IEC Guide 65

• Demonstrate competence in performing tests and be accredited by ISO/IEC Guide 25

• Familiar with related legislative, regulatory and administrative provisions of DGT


Slide 38


• At least one professional and full-time (foreign or domestic) personnel is to be designated for each accreditation scope subject to certification.

• The personnel involved in the certification process should be independent from those who conduct the testing.

• The certification personnel are to have technical expertise and knowledge in telecommunications, as well as be familiar with DGT rules, regulations and technical specifications.


Slide 39


• Relevant personnel must participate in appropriate training courses or forums conducted by the DGT.

• The certification personnel should have graduated from a domestic or foreign university/college and majored in telecommunications engineering, electrical engineering, electronic engineering or other relevant majors.


Slide 40

RCB Designation Process

• Submit Application Package to DGT• On-Site Assessment by DGT & CNAB• Sign a contract committing themselves to carrying

out the compliance approval process in accordance with DGT rules and procedures

• DGT issues an RCB Certificate• DGT makes this public on its Website

(www.dgt.gov.tw)


Slide 41

Recognized RCBs in Chinese Taipei

• Recognized TTE Certification Bodies:– Electronics Testing Center, Taiwan

– Telecommunication Laboratories, Chunghwa Telecom Co., Ltd.

• http://www.dgt.gov.tw/English/Type-approval/8.2/8.2.5/Rec-TTE-Body-3661.shtml


Slide 42

The Recognition Procedures of a Certification Body for Telecommunication Terminal Equipment

Submits an application package tothe DGT (refer to Article 8 of the guidelines)

Supplement materials within theprescribed time frame from thereceipt of notification

Receives application

Application denied

Conducts on-site assessment

Supplemented within prescribed

time frame?

Is the application package complete

and adequate?

No

YesYes

No

Applicant DGT

yes


Slide 43

Does the application comply with the Guidelines?

Meets the requirements within

prescribed time frame?

Issue the certificate

Address proposal for improvement withinprescribed time framefrom the receipt ofnotification

Application denied

Sign contract

Yes

No

No

Yes

The Recognition Procedures of a Certification Body for Telecommunication Terminal Equipment


Slide 44

Foreign Testing Lab as an MRA CAB

• Under Government’s (Ex:APEC Telecom) MRA, the foreign testing lab must be accredited by its own Accreditation Body and designated by its Designating Authority as an MRA CAB.

• Then, the Designating Authority of the exporting Party will exchange the list of designated domestic testing labs with the DGT for mutual recognition.

• Furthermore, the DGT will recognize the MRA CABs if the testing labs are able to test subjects according to the technical regulations of DGT.

• Once the MRA CABs are recognized by DGT, the DGT will so state in APEC TEL MRA Annex IV and make this public on its Website promptly.


Slide 45

Foreign Test Reports Accepted by Chinese Taipei

• DGT can accept the test reports provided by foreign testing labs designated by their correspondent authorities based on mutual recognition.

• The testing must follow the method specified in the DGT technical regulations, if such a testing method is prescribed. If no method is specified, reasonable testing must be performed. The test report must include the following: Name, trade name, model number of equipment Measurement setup diagram and description Name, trade and model number of testing facilities Technical regulations being performed Test items and their standards Verdict of test results

• The testing lab must submit its first application with the test report, including the test procedure, lab layout and photograph of the product.


Slide 46

Designation Process of Domestic CABs for a Foreign Party

• The domestic testing lab shall be accredited against foreign party’s technical requirements by CNLA.

• CNLA conducts on-site assessment and accredited with ISO/IEC Guide 25 (since 2001, ISO 17025).

• CNLA submits the accredited testing lab list with relevant documentation to DGT for designation.

The personnel’s (education, training and experience) →to evaluate personnel,s technical competence

SOP →to check technical validity of test procedure

The brand name, model number and function of test instruments → to judge whether the test instrument can fully satisfy foreign party’s test requirements


Slide 47

Designation Process of Domestic CABs for a Foreign Party

Calibration record of test instruments →to check adequacy and traceability

A sample test report→ to check accuracy and completeness of the test items and test results

• If everything is OK, the DGT will designate the testing lab as an MRA CAB that is competent to perform testing according to foreign party requirements.


Slide 48

Confidence Building in MRA CABs

Proficiency Testing– To ensure the testing laboratories are competent to

perform tests, the DGT commissioned the CNLA to conduct a proficiency testing program from 1999/6 to 2000/6.

– DGT required the 5 designated MRA CABs to participate in the proficiency testing program.

– The APLAC proficiency testing committee has officially listed these programs, which are still in use, as being international proficiency programs.

– To build confidence in these tests, the BSMI also supports the implementation of this program on a permanent basis.


Slide 49

Confidence Building in MRA CABs

• Uncertainty of Measurement– Since 2001, CNLA has been testing laboratory

assessments subject to ISO 17025. One of the assessment items, uncertainty of measurement, can elevate the technical competence of the recognized testing labs (RTL), thereby enhancing confidence in test results produced by the RTL.


Slide 50

Case Studies in MRA

Case I: APEC (Asia Pacific Economic Cooperation) member economies’ multilateral MRA under APEC Telecom MRA

Case II: U.S. and Chinese Taipei bilateral MRA under APEC Telecom MRA

Case III: The APLAC (Asia Pacific Laboratory Accreditation

Cooperation) accreditation bodies under APEC Telecom MRA (Multilateral)


Slide 51

Case I: APEC Member Economies’ Multilateral MRA

• The Text of the model APEC TEL MRA was finalized on April 30, 1998 and was endorsed at the APEC Telecom Ministerial Meeting on June 5, 1998.

• According to paragraph 9.2 of APEC TEL MRA, Australia, Canada, Hong Kong (China), Japan, Korea (R.O.K.), Singapore, Chinese Taipei and the United States have already informed the Chair of the APEC TEL to begin implementation of the APEC Telecom MRA that took effect on July 1, 1999.

• However, this arrangement is not in and of itself legally binding.


Slide 52

Case I: APEC Member Economies’ Multilateral MRA

• Scope of Technical Regulation Telecom, EMC and Electrical Safety

• Scope of Equipment network terminal attachment and other equipment subject to telecommunications regulation of each Party. In Chinese Taipei, it consists of telecommunications terminal equipment, base stations and RF repeaters of Type I telecommunications enterprises, low power RF devices and amateur radio equipment.


Slide 53

Case II:U.S.-Chinese Taipei Bilateral MRA

• The United States and Chinese Taipei concluded the process of exchange of letters to reach an agreement to begin the implementation of Telecom/EMC MRA on March 16, 1999.

• In the agreement, Chinese Taipei is to apply the Phase I Procedures in Appendix B of the APEC Telecom MRA for the recognition of testing laboratories designated by the United States as Conformity Assessment Bodies (CABs) and accept test reports from recognized U.S. CABs for conformity assessment of telecommunications equipment with the Technical Regulations of Chinese Taipei and vice versa.


Slide 54

Case II: U.S.-Chinese Taipei Bilateral MRA

• DGT is the Designating Authority of Chinese Taipei, and NIST is the Designating Authority of the United States.

• List of Recognized Testing Labs http://www.dgt.gov.tw/English/type-approval/8.1/lab-tw-3661.shtml


Slide 55

Case II: U.S.-Chinese Taipei Bilateral MRA

TE

IT BSMITest

Report

DGT

Recognized

Testing Labs

by U.S.

Test Report

Recognized Testing Labs by Chinese

Taipei

Test Report

FCC/NIST

Test Report

IT

TE

Chinese Taipei United States

Telecom

&EMC

EMC

Telecom

&EMC

EMC


Slide 56

Case III: APLAC Accreditation Bodies

• According to paragraph 7 of APEC TEL MRA, Australia, Hong Kong (China), Singapore and Chinese Taipei agreed on a joint note to implement Phase I procedures of the APEC TEL MRA, relying on mutual recognition arrangements among accreditation bodies to secure and simplify participation in this arrangement.

• The four economies sent the covering letter, enclosing the agreed information note, Annex I and Annex II, to the APEC TEL Chair and simultaneously made the announcements on August 5, 1999.


Slide 57

Case III : APLAC Accreditation Bodies

• The note is only an expression of our intent to work together to implement the Phase I procedures. It does not carry implications to create any legally binding obligations or international rights.

• Our main objective is to assist other economies to move forward an open and transparent system of conformity assessment. Therefore, we are prepared to have the participation of other economies who also belong to APLAC accreditation bodies.

• Australia, Hong Kong (China), Singapore and Chinese Taipei are able to recognize APLAC MRA partners’ (NATA, HOKLAS, SAC-SINGLAS, CNLA) accredited CABs for telecoms, EMC and electrical safety requirements.


Slide 58

Test Report

Test Report

Test Report

Test Report

Australia ACA

Hong KongOFTA

SingaporeTAS (IDA)

Chinese TaipeiDGT

NATA

SAC-SINGLAS

Testing Lab

Testing Lab

CNLA

Testing Lab

HOKLAS

Testing Lab

Test Reports with logo of ogo of recognized accreditation recognized accreditation bodybody will be accepted among the four economies.

Case III : APLAC Accreditation Bodies


Slide 59

Conclusion

Our Goals of Telecommunications Equipment Conformity AssessmentMRA are: One standard One test of conformity Worldwide acceptance

Presented by : Yi-Chang Tsai ( [email protected]) April 23-24, 2003Current Regulatory Approach for...

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