WTO ITA

1
WTO ITA

• Current Regulatory Approach for Information
  Technology Products of the Separate Customs
  Territory of Taiwan, Penghu, Kinmen and Matsu

2
Presentation Overview

• Regulatory Agencies of IT Products
• A Brief Introduction to BSMIs Authority
• Regulatory Overview
• Accreditation Body
• Conformity Assessment Body
• MRA Case Study
• Conclusion

3
Regulator

• Our Geographic Location

Map from http//go.hrw.com/atlas/norm_htm/asia.h
tm
4
Regulator

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

Map from http//go.hrw.com/atlas/norm_htm/taiwan
.htm
5
Regulatory Agencies
IT Products Government Agencies Organization
Structure
6
Regulatory Agencies

• Information 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

7
Regulatory Agencies (continued)

• IT Products DGT Contact Persons
• Mr. Hsi-Lan Hsu Tel [phone]
• Email hlhsu_at_dgt.gov.tw
• Mr. Yi-Chang Tsai Tel [phone]
• Email yctsai_at_dgt.gov.tw
• Fax [phone]
• IT Products BSMI Contact Person
• Mr. Bing-Yuan Liou Tel [phone]
• Fax [phone]
• Email by.liou_at_bsmi.gov.tw

8
A Brief Introduction to BSMIs Authority
Chinese Taipeis Regulatory Regime for
Information Technology Equipment (ITE )
(Excluding Radio Telecommunications
Terminal Equipment (RTTE))

• Designating Authority
• Bureau of Standards, Metrology and Inspection
  (BSMI),
  
• Ministry of Economic Affairs

9
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
10
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.
  

11
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

12
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

13
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 520
  probability)
  
• Compliance document issued if the sampled
  products pass testing
  
• Products can be shipped or imported and be placed
  on the market
  

14
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
  

15
Inspection Scheme (Cont.)

• 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

16
Inspection Scheme (Cont.)

• 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.

17
Inspection Scheme (Cont.)

• 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

18
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.

19
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.
  

20
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.

21
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.

22
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.

23
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
  Taipeis most important goals.
  

24
Further Information

• BSMI Website http//www.bsmi.gov.tw
• For more information, please contact
• Mr. Bing-Yuan Liou
• Tel [phone]
• Email by.liou_at_bsmi.gov.tw

25
Regulatory Overview
Three Telecommunications Laws
The Telecommunications Act
The Organizational Statute of Directorate Gene
ral of Telecommunications

The Statute of Chunghwa Telecom Co., Ltd.
Legislated Jan. 16, 1996
Enforced Feb. 5, 1996 Telecom Act Revised Oct.
10, 2002 Legal Basis for Telecom Reform Liberal
ization
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

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.
  

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
  

29
Classification of Equipment for Approval
30
Conformity Assessment Schema
Designating Authority/Regulator DGT
Testing Lab Accreditation Body
CNLA
Comply with ISO/IEC Guide 58
Certification Accreditation Body
CNAB
Comply with ISO/IEC Guide 61
Testing Laboratories Comply with ISO/IEC Guide 2
5
Certification Bodies Comply with ISO/IEC Guide 25
65
RCBs
CABs
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

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.

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.

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

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

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/la
  b-tw-3661.shtml

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

38
RCB Designation Criteria

• 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.

39
RCB Designation Criteria

• 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.

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)
  

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
  

42
The Recognition Procedures of a Certification
Body for Telecommunication Terminal Equipment
Applicant
DGT
Submits an application package to
the DGT (refer to Article 8 of
the guidelines)
Receives application
Is the application package complete and adequa
te?
Supplement materials within the
prescribed time frame from the
receipt of notification
No
yes
Supplemented within prescribed time frame?
Yes
Yes
Conducts on-site assessment
No
Application denied
43
The Recognition Procedures of a Certification
Body for Telecommunication Terminal Equipment
Does the application comply with the Guideline
s?
Address proposal for improvement within prescr
ibed time frame
from the receipt of notification
No
Yes
Meets the requirements within prescribed ti
me
frame?
Sign contract
Yes
No
Issue the certificate
Application denied
44
Foreign Testing Lab as an MRA CAB

• Under Governments (ExAPEC 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.

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.

46
Designation Process of Domestic CABs for a
Foreign Party

• The domestic testing lab shall be accredited
  against foreign partys 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 personnels (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 partys test
  requirements

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.

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.

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.

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)

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.

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.

53
Case IIU.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.

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/la
  b-tw-3661.shtml

55
Case II U.S.-Chinese Taipei Bilateral MRA
Telecom EMC
Test Report
TE
DGT
Test Report
TE
Telecom EMC
Recognized Testing Labs by U.S.
Recognized Testing Labs by Chinese Taipei
FCC/ NIST
EMC
IT
Test Report
IT
BSMI
Test Report
EMC
Chinese Taipei
United States
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.

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.

58
Case III APLAC Accreditation Bodies
Hong Kong OFTA
Australia ACA
HOKLAS
NATA
Testing Lab
Testing Lab
Test Reports with logo of recognized
accreditation body will be accepted among the
four economies.
Chinese Taipei DGT
Singapore TAS (IDA)
SAC-SINGLAS
CNLA
Testing Lab
Testing Lab
59
Conclusion

• Our Goals of Telecommunications Equipment
  Conformity Assessment
  
• MRA are
• One standard
• One test of conformity
• Worldwide acceptance