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WTO ITA

WTO ITA. Current Regulatory Approach for Information Technology Products of the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu. Presentation Overview. Regulatory Agencies of IT Products A Brief Introduction to BSMI’s Authority Regulatory Overview Accreditation Body

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WTO ITA

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  1. WTO ITA Current Regulatory Approach for Information Technology Products of the Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  3. Regulator Our Geographic Location * Map from http://go.hrw.com/atlas/norm_htm/asia.htm Current Regulatory Approach for IT products of Chinese Taipei

  4. Regulator The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu * Map from http://go.hrw.com/atlas/norm_htm/taiwan.htm Current Regulatory Approach for IT products of Chinese Taipei

  5. Regulatory Agencies IT Products Government Agencies Organization Structure Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  7. Regulatory Agencies (continued) • IT Products DGT Contact Persons • Mr. Hsi-Lan Hsu Tel: +886-2-2343-3650 Email: hlhsu@dgt.gov.tw • Mr. Yi-Chang TsaiTel: +886-2-2343-3836 Email: yctsai@dgt.gov.tw Fax: +886-2-2343-3699 • IT Products BSMI Contact Person • Mr. Bing-Yuan LiouTel: +886-2-2343-1906 Fax: +886-2-3343-3991 Email: by.liou@bsmi.gov.tw Current Regulatory Approach for IT products of Chinese Taipei

  8. A Brief Introduction to BSMI’s Authority BSMI Chinese Taipei’s Regulatory Regime for Information Technology Equipment (ITE ) (Excluding Radio & Telecommunications Terminal Equipment (R&TTE)) • Designating Authority: Bureau of Standards, Metrology and Inspection (BSMI), Ministry of Economic Affairs Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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 5~20% probability) • Compliance document issued if the sampled products pass testing • Products can be shipped or imported and be placed on the market Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  15. Inspection Scheme (Cont.) R3A001 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: Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  17. Inspection Scheme (Cont.) D3A001 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: Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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 Taipei’s most important goals. Current Regulatory Approach for IT products of Chinese Taipei

  24. Further Information • BSMI Websitehttp://www.bsmi.gov.tw • For more information, please contact: Mr. Bing-Yuan Liou Tel: +886-2-2343-1906 Email: by.liou@bsmi.gov.tw Current Regulatory Approach for IT products of Chinese Taipei

  25. Regulatory Overview Three Telecommunications Laws The Telecommunications Act The Organizational Statute of Directorate General 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 & Liberalization Current Regulatory Approach for IT products of Chinese Taipei

  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; Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  29. Classification of Equipment for Approval Current Regulatory Approach for IT products of Chinese Taipei

  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 25 Certification Bodies Comply with ISO/IEC Guide 25 & 65 RCBs CABs Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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) Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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 adequate? 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 Current Regulatory Approach for IT products of Chinese Taipei

  43. The Recognition Procedures of a Certification Body for Telecommunication Terminal Equipment Does the application comply with the Guidelines? Address proposal for improvement within prescribed time frame from the receipt of notification No Yes Meets the requirements within prescribed time frame? Yes Sign contract No Issue the certificate Application denied Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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 Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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. Current Regulatory Approach for IT products of Chinese Taipei

  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) Current Regulatory Approach for IT products of Chinese Taipei

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