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Approval Regulatory Framework by Gin-Shian Lou DGT, Chinese Taipei Email: james@dgt. gov. tw May Approval Regulatory Framework by Gin-Shian Lou DGT, Chinese Taipei Email: [email protected] gov. tw May 11, 2005

Outlines DGT Approval Regulatory Overview Approval Regulatory Schema Low Power RF Devices Technical Regulations Outlines DGT Approval Regulatory Overview Approval Regulatory Schema Low Power RF Devices Technical Regulations Terminal Equipment Technical Regulations Conformity Assessment Scheme Conformity Assessment Requirements Marking Requirements Market Surveillance and Enforcement Mutual Recognition of Test Report Mutual Recognition of Certification 2

Approval Regulatory Overview (1/9) DGT Equipment Approval Related Articles in Telecom Act 9 § Approval Regulatory Overview (1/9) DGT Equipment Approval Related Articles in Telecom Act 9 § 49, Network Equipment General Requirements § 4 § 39 50 2003 1999 Telecommunications 電信法 Act § 42 Ge ner § 48 § 46 § 44 Station General Requirements t en m uip ts Gene q n ral ISM o E eme Re di qui Ra quir rem d e lle l R ent o s ntr nera Co Ge § 48 , 50 ity r TE utho T A al ov pr Ap T al R TE equ irem ent s 3

Approval Regulatory Overview (2/9) DGT Telecommunications Act Equipment Approval Related Articles Article 42 Article Approval Regulatory Overview (2/9) DGT Telecommunications Act Equipment Approval Related Articles Article 42 Article 49 Article 44 Telecommunications Terminal Equipment Article 50 Controlled Telecommunications Radio Frequency Device 4

Approval Regulatory Overview (3/9) DGT Article 42, Telecommunications Act (1/2) The telecommunications terminal equipment Approval Regulatory Overview (3/9) DGT Article 42, Telecommunications Act (1/2) The telecommunications terminal equipment for connection to the telecommunications machinery and line facilities of a Type I telecommunications enterprise shall conform to technical specifications, and be certified and approved before import and sale. The technical specifications shall be prescribed announced by the Directorate General of Telecommunications (DGT). The DGT shall enact regulations regarding the compliance approval mode and procedure of the telecommunications terminal equipment, the issuance, renewal, replacement and termination of the certificate of approval, and the embossment, marking and use of Approval Label, as well as the regulations with respect to the supervision and administration of compliance approval. The aforementioned technical specifications must ensure the following: 5

Approval Regulatory Overview (4/9) DGT Article 42, Telecommunications Act (2/2) The connection shall not Approval Regulatory Overview (4/9) DGT Article 42, Telecommunications Act (2/2) The connection shall not damage telecommunications machinery and line facilities of Type I telecommunications enterprise, or malfunction of the said facilities. Any nuisance shall not be caused to other users of the telecommunication machinery and line facilities of a Type I telecommunications enterprise. The demarcation of responsibility between the telecommunications machinery and line facilities of a Type I telecommunications enterprise and the terminal equipment connected by users shall be clearly stipulated. Ensure electromagnetic compatibility to harmonize and effective use of the radio spectrum. Ensure electrical safety to prevent harm to network operator personnel or users. 6

Approval Regulatory Overview (5/9) DGT Article 44, Telecommunications Act The DGT or the certification Approval Regulatory Overview (5/9) DGT Article 44, Telecommunications Act The DGT or the certification bodies commissioned by the DGT shall be responsible for compliance approval of telecommunications terminal equipment. Regulations governing the qualifications, the scope and limitations of delegated power, cancellation or termination of the commission, and supervision related to the commission of the aforementioned certification bodies shall be enacted by the DGT. 7

Approval Regulatory Overview (6/9) DGT Article 49, Telecommunications Act (1/2) To ensure national security Approval Regulatory Overview (6/9) DGT Article 49, Telecommunications Act (1/2) To ensure national security and maintain the orderly sequence of radio waves, permission to manufacture, import, install or possess controlled telecommunications radio frequency devices shall be obtained from the MOTC; the model numbers and quantities of such devices manufactured or imported shall be reported to the MOTC for further reference. Regulations governing the operation permit of manufacture or import of controlled telecommunications radio frequency devices, the issuance, renewal, replacement and termination of operation license, administration of manufacture, import, installation and possession of the said devices, and other related matters shall be enacted by the MOTC. 8

Approval Regulatory Overview (7/9) DGT Article 49, Telecommunications Act (2/2) No controlled telecommunications radio Approval Regulatory Overview (7/9) DGT Article 49, Telecommunications Act (2/2) No controlled telecommunications radio frequency device shall be manufactured, imported, sold or publicly displayed unless it has received type approval and recognition of inspections. However, the manufacture of such devices in connection with academic studies, technological research and developments or experiments, as well as uses exclusively for exportation, re-importation after exportation and other uses permitted by the MOTC of such devices are exempted. The items of controlled telecommunications radio frequency devices mentioned in the first paragraph shall be announced by the MOTC. 9

Approval Regulatory Overview (8/9) DGT Article 50, Telecommunications Act Technical specifications for controlled telecommunications Approval Regulatory Overview (8/9) DGT Article 50, Telecommunications Act Technical specifications for controlled telecommunications radio frequency device shall be mandated announced by the DGT. In the event that national standards are already in place, said standards shall prevail. Regulations governing the compliance approval mode and procedure of the devices mentioned in the preceding paragraph, the issuance, renewal, replacement and termination of inspection or compliance approval or certificate of approval, the affixing, embossment and use of the inspection Approval Label, as well as regulations related to the supervision and administration of inspection shall be enacted by the DGT. 10

Approval Regulatory Overview (9/9) DGT Article 50, Telecommunications Act The DGT or the certification Approval Regulatory Overview (9/9) DGT Article 50, Telecommunications Act The DGT or the certification bodies engaged by the DGT shall conduct the compliance approval on of the controlled telecommunications radio frequency devices. Rules governing the qualifications of the said certification bodies, the delegated power, cancellation or termination of the engagement, and supervision related to the engagement shall be enacted by the DGT. The inspection and technical specifications as prescribed in Article 42 shall apply to controlled telecommunications radio frequency devices that are used in telecommunications terminal equipment. 11

Approval Regulatory Schema Compliance Approval requirements Telecom Act Regulatory requirements Technical requirements DGT Ø Approval Regulatory Schema Compliance Approval requirements Telecom Act Regulatory requirements Technical requirements DGT Ø Compliance Approval Regulations on Controlled Telecommunications Radio-Frequency Devices Ø Compliance Approval Regulations of Telecommunications Terminal Equipment Ø Administration Regulations of Regulatory Certification Body for Controlled Telecommunications Radio-Frequency Devices Ø Administration Regulations of Regulatory Certification Body for Telecommunications Terminal Equipment Ø Administrative Regulations on the Controlled Telecommunications Radio-Frequency Devices Ø Administrative Regulations on Low Power Radio Waves Radiated Devices Ø Administrative Regulations on Radio Waves of Industrial, Scientific, Medical Equipment Ø LP Device: LP 0002(1) Ø TTE: PSTN(5); ISDN(1); PLMN(8); S-PCN(1) 12

Low Power RF Devices Technical Regulations (1/5) DGT Regulations: Administrative Regulations on the Controlled Low Power RF Devices Technical Regulations (1/5) DGT Regulations: Administrative Regulations on the Controlled Telecommunications Radio-Frequency Devices Administrative Regulations on Low Power Radio Waves Radiated Devices Compliance Approval Regulations on Controlled Telecommunications Radio-Frequency Devices Technical Specifications: LP 0002: Low Power RF Devices Technical Specifications 13

Low Power RF Devices Technical Regulations (2/5) DGT Article 3, Administrative Regulations on the Low Power RF Devices Technical Regulations (2/5) DGT Article 3, Administrative Regulations on the Controlled Telecommunications Radio-Frequency Devices The controlled telecommunications devices(CTD) indicate those authorized radio frequency devices specified in the Section 4, Article 49 of the Telecommunications Act. Two Types for above Radio Equipment: 1) A License to operate a radio apparatus: Pursuant to paragraph 6 of Article 14, Article 47, Article 46 of ACT 2) License Exempt to operate a radio apparatus: through conformity Assessment Process Ex: Low Power License-Exempt Radio communication Devices 14

Low Power RF Devices Technical Regulations (3/5) DGT Article 10, Administrative Regulations on the Low Power RF Devices Technical Regulations (3/5) DGT Article 10, Administrative Regulations on the Controlled Telecommunications Radio-Frequency Devices The controlled telecommunications radio frequency devices shall not be manufactured, imported, sold or publicly displayed if they acquired neither type approvals nor recognition of inspections. However, the manufacture, exportation only and other purposes permitted by the MOTC for those devices in connection with academic studies, technological researches and developments, or experiments are ruled out. 15

Low Power RF Devices Technical Regulations (4/5) DGT Article 4, Administrative Regulations on Low Low Power RF Devices Technical Regulations (4/5) DGT Article 4, Administrative Regulations on Low Power Radio Waves Radiated Devices The Low Power RF Device means the controlled telecommunications radiofrequency devices in compliance with “Low-power Radio-frequency Devices Technical Specifications” Article 5, Administrative Regulations on Low Power Radio Waves Radiated Devices The compliance approval of low power radio-frequency devices shall be conducted pursuant to ”Compliance Approval Regulations on Controlled Telecommunications Radio Frequency Devices” and “Low-power Radio-frequency Devices Technical Specifications”. A certificate of approval will be issued to the applicant while DGT or regulatory certification body (RCB) approves the low power radio-frequency devices in accordance with the regulations specified in the preceding Paragraph. The format of certificate is defined and determined by DGT. 16

Low Power RF Devices Technical Regulations (5/5) DGT Article 10, Administrative Regulations on Low Low Power RF Devices Technical Regulations (5/5) DGT Article 10, Administrative Regulations on Low Power Radio Waves Radiated Devices The manufacturer, importer or supplier of low-power radio-frequency devices shall print the requirements stipulated in Article 12, 14 on the operation manual or instruction guide. Article 12, Administrative Regulations on Low Power Radio Waves Radiated Devices Without permission granted by the DGT, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to a approved low power radio-frequency devices. Article 14, Administrative Regulations on Low Power Radio Waves Radiated Devices The low power radio-frequency devices shall not influence aircraft security and interfere legal communications; If found, the user shall cease operating immediately until no interference is achieved. 17

Terminal Equipment Technical Regulations (1/9) DGT Regulation: Compliance Approval Regulations of Telecommunications Terminal Equipment Terminal Equipment Technical Regulations (1/9) DGT Regulation: Compliance Approval Regulations of Telecommunications Terminal Equipment Technical Specifications: Ä Ä Ä Ä PLMN 01: GSM 900 and DCS 1800 Mobile Equipment PLMN 02: 1900 MHz Digital Low Tier PHS Radio Terminal Equipment PLMN 03: 1900 MHz Digital Low Tier PACS Radio Terminal Equipment PLMN 04: Trunked Radio Terminal Equipment PLMN 05: Mobile Data Radio Terminal Equipment PLMN 06: Paging Receiver Radio Terminal Equipment PLMN 07: 1880 -1895 MHz Wireless Private Branch Exchange and Radio Terminal Equipment PLMN 08: The Third Generation Mobile Telecommunication Terminal Equipment PSTN 01: Terminal Equipment for Connection to Public Switched Telephone Network RTTE 01: 2. 4 GHz. Radio-frequency Telecommunications Terminal Equipment ADSL 01: Asymmetric Digital Subscriber Line Terminal Equipment and POTS Splitter ID 0002: DS 1 Equipment Type Approval Guidelines IT 0002: CT-2 Wireless Private Branch Exchange System Equipment Type Approval Guidelines IS 6100: ISDN Terminal Equipment IS 2019: 1. 6/2. 4 GHz Satellite Personal Communications Networks (S-PCN) Mobile Earth Stations (MESs) Technical Requirements and Type Approval Guidelines 18

Terminal Equipment Technical Regulations (2/9) DGT ◎ Definition of TTE Article 2, Compliance Approval Terminal Equipment Technical Regulations (2/9) DGT ◎ Definition of TTE Article 2, Compliance Approval Regulations of Telecommunications Terminal Equipment The Telecommunications Terminal Equipmentioned herein shall refer to any digital or analog equipment that interfaces with the end point of the Public Switched Telecommunications Network by using wireless or wired transmission media and conducts communications by means of optical or electromagnetic wave. 19

Terminal Equipment Technical Regulations (3/9) DGT ◎ Principle of TTE Technical Specifications Article 4, Terminal Equipment Technical Regulations (3/9) DGT ◎ Principle of TTE Technical Specifications Article 4, Compliance Approval Regulations of Telecommunications Terminal Equipment o The relevant TTE technical specifications shall be formulated announced in public by the DGT o The aforementioned technical specifications shall not only contain test items and standards, but also ensure the following: Ø The connection should not damage telecommunications network facilities of Type I telecommunications enterprises, or malfunction the said facilities. Ø Any nuisance shall not be caused to other users of the telecommunications network facilities of Type I telecommunications enterprises. Ø The demarcation of responsibility between the telecommunications network facilities of Type I telecommunications enterprises and the terminal equipment connected by users shall be clearly clarified. Ø The connection of TTE shall ensure it is normally interfaced with the telecommunications network facilities of Type I telecommunications enterprises. Ø Ensure Electro-Magnetic Compatibility (hereinafter as EMC) to harmonize and effective use of the radio spectrum. Ø Ensure electrical safety to prevent harm to network operator personnel or users. 20

Terminal Equipment Technical Regulations (4/9) ◎ Essential Requirements of TTE ØHarm to network and Terminal Equipment Technical Regulations (4/9) ◎ Essential Requirements of TTE ØHarm to network and users Limit to ØElectrical safety ØElectromagnetic Compatibility 21 DGT

Terminal Equipment Technical Regulations (5/9) DGT ◎ EMC/Electrical Safety Requirements for TTE Article 4, Terminal Equipment Technical Regulations (5/9) DGT ◎ EMC/Electrical Safety Requirements for TTE Article 4, Compliance Approval Regulations of Telecommunications Terminal Equipment The test items relating to EMC and electrical safety of TTE and date of enforcement shall be announced in public by the DGT. EMC test : All TTE are requested to conduct EMC test to CNS 13438 from June 28, 2002. Electrical Safety test : Up to now, the following TTE are requested to conduct Electrical Safety test to CNS 14336 from June 28, 2002. ãx. DSL ãIP Phone ãCable Modem ãDS 1 TTE ãCellular Phone (IEC/EN 60950, Jan 7, 2004) 22

Terminal Equipment Technical Regulations (6/9) DGT ◎ SAR Requirements for TTE (1/4) Enforcement Date: Terminal Equipment Technical Regulations (6/9) DGT ◎ SAR Requirements for TTE (1/4) Enforcement Date: From July 1, 2001 on, Marking warnings on cellular phone, measuring the SAR values and posting the SAR values of cellular phone were mandated by DGT. That is, since July 1, 2001, applicants for compliance approval of cellular phones are required to submit SAR test reports or verdict data to the DGT. (Ref: Specific Absorption Rate, SAR) SAR standards: ã ã 2 G Cell Phone(PLMN 01, Section 3); 3 G Cell Phone(PLMN 08, Section 3. 1. 2) The DGT adopts the same SAR limits “ 1. 6 W/kg, as measured over 1 gram of human tissue” as the FCC and IEEE does. Meanwhile, the DGT adopts the required measurements procedure for the standard, such as FCC Part 2. 1093, FCC OET Bulletin 65(Supplement C), ANSI/IEEE C 95. 1 and ANSI/IEEE C 95. 3, Std. 1528 -200 x or the ANSI/IEEE relevant latest requirements. 23

Terminal Equipment Technical Regulations (7/9) DGT ◎ SAR Requirements for TTE (2/4) The SAR Terminal Equipment Technical Regulations (7/9) DGT ◎ SAR Requirements for TTE (2/4) The SAR test report shall contain the followings: 1. Equipment name, brand name and model number. 2. Testing facility connection diagram and description. 3. Name, brand name and model number of test instruments. 4. Test items and standards. 5. Test data and verdict of test results. 6. Date of acceptance and completion of testing. 24

Terminal Equipment Technical Regulations (8/9) DGT ◎ SAR Requirements for TTE (3/4) RF Exposure Terminal Equipment Technical Regulations (8/9) DGT ◎ SAR Requirements for TTE (3/4) RF Exposure Warning Label: (PLMN 01, Section 3. 9; PLMN 08, Section 3. 1. 2) RF Exposure Warning Label Warning: ”For Reducing RF Influence, Use Properly “ Labeling method: Label accordingly on handset, carton, or in user’s manual. Label requirements and Format SAR label content: SAR Label “ SAR limit 1. 6 W/Kg; after testing value: W/Kg” Labeling method: Label accordingly on handset, carton, or in user’s manual. 25

Terminal Equipment Technical Regulations (9/9) DGT ◎ SAR test reports how to be accepted Terminal Equipment Technical Regulations (9/9) DGT ◎ SAR test reports how to be accepted by the DGT (4/4) For Domestic testing labs: The test report shall be issued by the testing labs with the SAR scope accredited by the CNLA and comply with the SAR requirements of the DGT. Foreign testing labs: The test report shall be issued by the testing labs with the SAR scope accredited by the third party and comply with the SAR requirements of the DGT. For MRA CAB: The test report shall be issued by the testing labs with the SAR scope accredited by its Accreditation Body, designated by its Designating Authority as a MRA CAB and comply with the SAR requirements of the DGT. 26

Conformity Assessment Schema DGT Designating Authority/Regulator [DGT] Appointed/Designated Accredited/Designated Testing Lab Accreditation Body [TAF/CNLA] Conformity Assessment Schema DGT Designating Authority/Regulator [DGT] Appointed/Designated Accredited/Designated Testing Lab Accreditation Body [TAF/CNLA] Product Certification Accreditation Body [TAF/CNAB] Comply with ISO/IEC Guide 58 Comply with ISO/IEC Guide 61 CNLA: Chinese National Laboratory Accreditation CNAB: Chinese National Accreditation Board Accredited Testing Labs Certification Bodies Comply with ISO/IEC 17025& ISO/IEC Guide 65 CABs TAF: Taiwan Accreditation Foundation 27

Conformity Assessment Requirements (1/12 ) DGT ◎ Regulations Amendments Regulations amended ( Coming into Conformity Assessment Requirements (1/12 ) DGT ◎ Regulations Amendments Regulations amended ( Coming into force in Nov. 2004): Compliance Approval Regulations Telecommunications Equipment Compliance Approval Regulations of Telecommunications Terminal Equipment on Controlled Outline of the amendment SDo. C (Supplier’s Declaration of Conformity) is introduced as conformity assessment requirements. Foreign manufacturers can directly apply for compliance approval. Electronic Filing System for the public to submit application package is introduced. 28

Conformity Assessment Requirements (2/12 ) DGT ◎ Two Types of Conformity Assessment Process for Conformity Assessment Requirements (2/12 ) DGT ◎ Two Types of Conformity Assessment Process for TTE and LP Supplier Declaration of Compliance (SDo. C) Certification (Type Approval) Technical Regulations 29

Conformity Assessment Requirements (3/12 ) DGT ◎ Definition of Type Approval and SDo. C Conformity Assessment Requirements (3/12 ) DGT ◎ Definition of Type Approval and SDo. C for TTE and LP Ö Type Approval: Apply to the approval procedure by the manufacturer, importer or distributor in accordance with the brand name, model number of TTE/LP that shall be submitted to the Directorate General of Telecommunications or DGT recognized certification bodies. Ö Supplier Declaration of Conformity(SDo. C): A process in which the Declaring Party has the TTE/LP tested and declare in a signed application form accompanying with the required document to RCB that the TE complies with the appropriate technical standards. 30

Conformity Assessment Requirements (4/12 ) ◎ Category of Compliance Approval for TTE and LP Conformity Assessment Requirements (4/12 ) ◎ Category of Compliance Approval for TTE and LP Category of Compliance Approval Sale use Private use SDo. C Type Approval by Piece (For LP device only) 31 DGT

Conformity Assessment Requirements (5/12 ) ◎ Compliance Approval Requirements for TTE and LP 32 Conformity Assessment Requirements (5/12 ) ◎ Compliance Approval Requirements for TTE and LP 32 DGT

Conformity Assessment Requirements (6/12 ) DGT ◎ Elements of Test Report for TTE and Conformity Assessment Requirements (6/12 ) DGT ◎ Elements of Test Report for TTE and LP o The test report includes: 3 Color photographs larger than 4 R of the unit to show details of external 3 3 3 appearance and internal construction Name, trade name, model number of equipment Name and address of applicant Name and address of testing lab Unique identity for test report and page test report Testing instrument connection diagram and description Name, trade and model number of testing facilities as well as date of calibration and period of validity Technical regulations be performed Test items and its standards Verdict of test results Date of acceptance and completion of testing 33

Conformity Assessment Requirements (7/12 ) DGT ◎ Technical Requirements for TTE and LP o Conformity Assessment Requirements (7/12 ) DGT ◎ Technical Requirements for TTE and LP o TTE and CTD both shall comply with the test items and standards as specified in the relevant technical specifications; where the test items and standards are not available, testing shall be performed in accordance with the following order: Ⅰ. National standards Ⅱ. Standards specified by the international standard organization Ⅲ. Standards specified by the regional standard organization +National Standards: CNS +International Standards: ITU-T; ITU-R; ISO; IEC; JTC 1 +Regional Standard: ETSI; ANSI; TTC; CEN; T 1 34

DGT Conformity Assessment Requirements (8/12 ) ◎ Conformity Assessment Procedure for TTE and LP DGT Conformity Assessment Requirements (8/12 ) ◎ Conformity Assessment Procedure for TTE and LP (Sale Use) R T L Applicant Testing Equipment Sample Test Report 1. Application Form 2. Copies of related identification documents 3. Technical documents R B Accept application and charge approval fees Supplement within 1 months on receipt of notification from RCB Supplement within prescribed time frame C No Yes Is the supplement complete and adequate No Is the application package complete and adequate? Yes No Turn down the application Fail Applicant will receive notification of failure and shall apply for secondary review within 2 months Equipment conformity assessment Pass Application for secondary review within prescribed time frame Yes Pass secondary review? No No Turn down the application 35 Yes Issue certificate of approval

Conformity Assessment Requirements (8/12 ) DGT ◎ Conformity Assessment Procedure for TTE and LP Conformity Assessment Requirements (8/12 ) DGT ◎ Conformity Assessment Procedure for TTE and LP (Private Use) R Applicant 1. Application Form 2. Equipment sample 3. Copies of related documents 4. Technical documents C B Accept Application and charge approval fees identification Supplement within 1 months on receipt of notification from RCB Supplement within prescribed time frame No Turn down the application Is the application package complete and adequate? No Yes Is the supplement complete and adequate No Applicant will receive notification of failure and shall apply for secondary review within 2 months Yes Fail Equipment conformity assessment Pass Application for secondary review within prescribed time frame Pass secondary review? No No Turn down the application 36 Issue Certificate of approval and label

Conformity Assessment Requirements (9/12 ) DGT ◎ SDo. C for TTE and LP o Conformity Assessment Requirements (9/12 ) DGT ◎ SDo. C for TTE and LP o Planning to the products apply SDo. C: Ä The products has short life cycle. Ä The Products has stable quality and low Safety risks. Ä Less impact on consumers o Starting with small area of products, to see the knowledge and cooperation manufacturers, importers and distributors have to meet the certification regulations. o The items of equipment and date of implementation applicable to the SDo. C procedure will be announced by the DGT. It is expected to put into force in the end of 2005. 37

Conformity Assessment Requirements (10/12 ) DGT ◎ SDo. C and Registration Requirements for TTE Conformity Assessment Requirements (10/12 ) DGT ◎ SDo. C and Registration Requirements for TTE and LP Ä Equipment testing must be performed by DGT recognized testing laboratories Ä Compliance Folder are kept by RCB. Ä Sample equipment, testing software and special testing facilities are kept by Declaring Party for 5 years until the equipment doesn’t be manufactured or imported Ä The Equipment models will be registered by RCB. 38

Conformity Assessment Requirements (11/12 ) DGT ◎ SDo. C and Registration Procedure for TTE Conformity Assessment Requirements (11/12 ) DGT ◎ SDo. C and Registration Procedure for TTE and LP (1/2) F Submission to RCB –Registration application form –User Manuel –Spec. document –Circuit diagram or Block diagram –Test report –Certificate of establishment for legal entity –Operation certificate of CTD (Foreign manufacturers exempted) –Other documents specified by DGT – 5 Compact Discs including the above information –Registration fee 39 are

Conformity Assessment Requirements (12/12 ) DGT ◎ SDo. C and Registration Procedure for TTE Conformity Assessment Requirements (12/12 ) DGT ◎ SDo. C and Registration Procedure for TTE and LP (2/2) Ä Declaring Party action Ä RCB action –Review for completeness –Grant Certificate of SDo. C – Register Equipment on the List –Label the Equipment –Distribute the Equipment for market Ä SDo. C Mark showed as below: Xxx. YYyyy=z XXXyyy. RFDzzzz-x X : RCB Identification xx : Year Identification YY : Equipment Category yyy : Serial No. z : Identify as series products XXX: RCB Identification yyy : Year Identification zzzz: Serial No. x : Identify as series products, a-z 40

Marking Requirements (1/6) DGT ◎ Label Requirements F The exclusive right of use relating Marking Requirements (1/6) DGT ◎ Label Requirements F The exclusive right of use relating to Approval Label belongs to the one who has been granted the certificate of approval. F When the certificate holder agrees to empower its approval label to others with respect to the same brand name and model number and submits a signed consent statement accompanying with the required documents to the DGT, the DGT will send an acknowledgement to the original party after reviewing the material submitted. F Certified equipment shall bear the identifying marks for market. F The identifying marks shall be affixed to the certified equipment. 41

Marking Requirements (2/6) DGT ◎ Label Empowerment Process ÄSubmission by Certificate Holder –Authorization Letter Marking Requirements (2/6) DGT ◎ Label Empowerment Process ÄSubmission by Certificate Holder –Authorization Letter –Compliance Approval Certificate or SDo. C Certificate –Legal Entity Certificate of Authorized Party ÄRCB action –Review for completeness –Send acknowledgement to the original certificate holder 42

Marking Requirements (3/6) DGT ◎ TTE Approval Mark -For Sale Use: X : RCB Marking Requirements (3/6) DGT ◎ TTE Approval Mark -For Sale Use: X : RCB Identification xx : Year Identification YY : Equipment Category yyy : Serial No. z : Identify as series products Xxx. YYyyy-z A : stand for “DGT” xx : Year Identification YY : Equipment Category yyy : Serial No. z : Certified regulatory station of DGT -For Private Use: Axx. YYyyy/z N: Northern Regional Station; C: Central Regional Station; S: Southern Regional Station 43

Marking Requirements (4/6) DGT ◎ Low -For Sale Power RF Devices Approval Mark Use: Marking Requirements (4/6) DGT ◎ Low -For Sale Power RF Devices Approval Mark Use: XXX: RCB Identification yyy : Year Identification zzzz: Serial No. x : Identify as series products, a-z XXXyyy. LPDzzzz-x -For Approval by Piece: xxx : Year Identification yyyy: Serial No. DGTxxx. LPDyyyy -For Private Use: xxx : Year Identification y : Certified regulatory station of DGT zzzz: Serial No. DGTxxx. LPDyzzzz 44

Marking Requirements (5/6) ◎ Warning Label (Indoor Wireless TTE products) ◎ Warning Label (Cellular Marking Requirements (5/6) ◎ Warning Label (Indoor Wireless TTE products) ◎ Warning Label (Cellular Phone) 45 DGT

Market Surveillance (1/3) DGT o There's a requirement specified that RCBs are to perform Market Surveillance (1/3) DGT o There's a requirement specified that RCBs are to perform some surveillance of the products they certify o Each RCB is required to have a market surveillance program in place to monitor all of the products it certifies o RCB is being carried out surveillance program mandatory o Each RCB needs to define what market surveillance it plans to perform and that DGT would assess each RCB's plan every year. 46

Market Surveillance (2/3) DGT o DGT/RCB determine whether a certified equipment maintains conformity with Market Surveillance (2/3) DGT o DGT/RCB determine whether a certified equipment maintains conformity with technical standards and the identity by sampling in the market. o Surveillance Method ã Electric Characteristics Test ã Examine conformity with the technical regulations ã Comparison and Verification ã Identity with color photographs 47

Market Surveillance (3/3) o Performed by DGT ã Randomly ã In o response to Market Surveillance (3/3) o Performed by DGT ã Randomly ã In o response to complaints Performed by RCBs ã For apparatus that they have certified o May result in testing to technical specifications o Fines will be applied 48 DGT

Mutual Recognition of Test Report (1/5) DGT ◎ Phase I of MRA implementation Recognized Mutual Recognition of Test Report (1/5) DGT ◎ Phase I of MRA implementation Recognized Testing Lab (RTL)Designation Criteria p Legal entity which has the technical competence to perform the tests p Accredited with ISO/IEC 17025 p Demonstration of technical competence in performing the tests. p Technological knowledge and experience of relevant product p Familiar with legislative, regulatory and administrative provisions 49

Mutual Recognition of Test Report (2/5) DGT ◎ Phase I of MRA implementation Domestic Mutual Recognition of Test Report (2/5) DGT ◎ Phase I of MRA implementation Domestic RTL Designation Process o Submit application package to CNLA will review the application package. If it is acceptable, the process for the accreditation will be undertaken by CNLA o CNLA will issue a RTL accreditation certificate to applicant if competent and submit the accredited testing lab list to DGT for RTL designation and recognition. o DGT will make this public on its website (www. dgt. gov. tw) 50

Mutual Recognition of Test Report (3/5) DGT ◎ Phase I of MRA implementation DGT Mutual Recognition of Test Report (3/5) DGT ◎ Phase I of MRA implementation DGT how to recognize foreign testing lab as the MRA CAB? o Under APEC Telecom MRA, the foreign testing lab must be accredited by its Accreditation Body and designated by its Designating Authority as a MRA CAB. o Then, the Designating Authority of exporting Party will exchange the list of designated testing lab with DGT for mutual recognition. o Furthermore, the DGT will recognize the MRA CABs if the testing labs are competent to perform testing subject to technical regulations of DGT. o Once the MRA CABs are recognized by DGT, the DGT will make this public on our Website soon. 51

Mutual Recognition of Test Report (4/5) DGT ◎ Phase I of MRA implementation Foreign Mutual Recognition of Test Report (4/5) DGT ◎ Phase I of MRA implementation Foreign test reports how to be accepted by Chinese Taipei (1/2) o Under the APEC Telecom MRA, DGT can accept the test reports provided by the recognized foreign testing lab designated by the correspondent party based on mutual recognition. o The testing must follow the method specified in the DGT technical regulations if such test method is prescribed. If no test method is specified, reasonable testing will be allowed. The test report at least must include: 3 Color photographs larger than 4 R of the unit to show details of external appearance and internal construction 3 Name, trade name, model number of equipment 3 Name and address of applicant 3 Name and address of testing lab 3 Unique identity for test report and page test report 3 Testing instrument connection diagram and description 52

Mutual Recognition of Test Report (5/5) DGT ◎ Phase I of MRA implementation Foreign Mutual Recognition of Test Report (5/5) DGT ◎ Phase I of MRA implementation Foreign test reports how to be accepted by Chinese Taipei (2/2) 3 Name, trade and model number of testing facilities as well as date of calibration and period of validity 3 Technical regulations be performed 3 Test items and its standards 3 Verdict of test results 3 Date of acceptance and completion of testing o The testing lab must submit its first application with the test report, including the test procedures, lab layout and photos. 53

Mutual Recognition of Certification (1/16) DGT ◎ Phase II of MRA implementation Rules for Mutual Recognition of Certification (1/16) DGT ◎ Phase II of MRA implementation Rules for RCB o To smoothly promote phase II procedures of APEC Telecom MRA and make preparation in advance to implement mutual acceptance of equipment certifications with other APEC economies, the following rules are stipulated and promulgated. ë Administration Regulations of Regulatory Certification Body for ë Telecommunications Terminal Equipment Administration Regulations of Regulatory Certification Body for Controlled Telecommunications Radio-Frequency Devices o The two rules provides for the criteria, procedures for designating a RCB, as well as the responsibilities and obligation of a RCB. 54

Mutual Recognition of Certification (2/16) DGT ◎ Phase II of MRA implementation Designation of Mutual Recognition of Certification (2/16) DGT ◎ Phase II of MRA implementation Designation of a RCB o The DGT will form a technical team to accredit the organization which is interested and competent to be RCB. o An entity accredited by the DGT will be designated as a RCB. o The DGT will also recognize a CB designated by a foreign Designating Authority in accordance with the terms of APEC Telecom MRA. o A list of designated RCBs will be published by the DGT. 55

Mutual Recognition of Certification (3/16) DGT ◎ Phase II of MRA implementation RCB Designation Mutual Recognition of Certification (3/16) DGT ◎ Phase II of MRA implementation RCB Designation Criteria (1/2) o Legal entity o Not be a importer, designer, manufacturer, supplier of TTE/LP device nor being engaged in these activities o Accredited to ISO/IEC Guide 65 o Equipped with local testing laboratories which demonstrate competence in performing tests and accredited to ISO/IEC 17025 accredited by the DGT or a local Recognized Accreditation Body ò A foreign RCB shall also equipped with testing lab which demonstrate competence in performing tests and accredited to ISO/IEC 17025 o Familiar with legislative, regulatory and administrative provisions of DGT o Sign a contract by which they commit themselves to carry out compliance approval process in accordance with DGT rules and procedures (not applicable to foreign RCB) 56

Mutual Recognition of Certification (4/16) DGT ◎ Phase II of MRA implementation RCB Designation Mutual Recognition of Certification (4/16) DGT ◎ Phase II of MRA implementation RCB Designation Criteria (2/2) o Designate at least one professional and full-time foreign or domestic personnel for each accreditation scope subject to certification. (Note: one more certifier for TTE, two more certifier for LP device) o The personnel involved in the certification process should be independent from those conduct the testing. o The certification personnel shall have the technical expertise and knowledge in telecommunications, as well as being familiar with the DGT rules, regulations and technical specifications. o The certification personnel is requested to be graduated from the domestic or foreign university/college and majored in telecommunications engineering, electrical engineering, electronic engineering or other relevant majors. 57

Mutual Recognition of Certification (5/16) DGT ◎ Phase II of MRA implementation How to Mutual Recognition of Certification (5/16) DGT ◎ Phase II of MRA implementation How to recognize foreign certification body as the RCB? o Under APEC Telecom MRA, the foreign certification body must be accredited by its Accreditation Body and designated by its Designating Authority as a MRA CAB. o Then, the Designating Authority of exporting Party will exchange the list of designated accreditation body with DGT for mutual recognition. o Furthermore, the DGT will recognize the MRA CABs if the certification body are competent to perform certification subject to technical regulations of DGT. o Once the MRA CABs are recognized as the RCBs by DGT, the DGT will make public on our Website soon. 58

Mutual Recognition of Certification (6/16) DGT ◎ Phase II of MRA implementation Responsibility of Mutual Recognition of Certification (6/16) DGT ◎ Phase II of MRA implementation Responsibility of a RCB (1/3) A RCB shall--o Certify equipment in accordance with the DGT’s rules in the name of RCB and in the written form o Provide fair and equitable treatment o Send certified products list to DGT o Perform post-market surveillance activities, under instructions or request by the DGT òA foreign RCB may appoint a local organization to perform market surveillance activities. o Report the outcomes of market surveillance to the DGT(at least 5% of the total number of products certified in a year). 59

Mutual Recognition of Certification (7/16) DGT ◎ Phase II of MRA implementation Responsibility of Mutual Recognition of Certification (7/16) DGT ◎ Phase II of MRA implementation Responsibility of a RCB (2/3) o Submit copies of each application package to the DGT (complete application until the contract is due) o All application documentation shall be recorded on the CD and send to DGT for reference. o Set a electrical database to store all applications and list of certified product o Authorize DGT to review all the certified equipment information stored in the database set up by the RCB via internet o Accept MRA CABs test reports o Hold 2 workshops per year to introduce the certification regulations and procedure to the public 60

Mutual Recognition of Certification (8/16) DGT ◎ Phase II of MRA implementation Responsibility of Mutual Recognition of Certification (8/16) DGT ◎ Phase II of MRA implementation Responsibility of a RCB (3/3) o Charge fees for processing applications in accordance with the fees schedule stipulated by the MOTC o Keep confidential treatment regarding to material submitted with an application which contain trade secret or other information that would be guarded from competitors requested/identified by the applicant, in accordance with the relevant regulations of information/business protection. 61

Mutual Recognition of Certification (9/16) DGT ◎ Phase II of MRA implementation Limitations of Mutual Recognition of Certification (9/16) DGT ◎ Phase II of MRA implementation Limitations of a RCB(1/2) A RCB can not--o Violate the rules o Refuse audit without acceptable reason o Default on conducting certification cases o Overrun the scope not empowered or not listed on the contract o Provide consultation services to the applicants for compliance approval or change technical characteristic of the equipment applied for approval 62

Mutual Recognition of Certification (10/16) DGT ◎ Phase II of MRA implementation Limitations of Mutual Recognition of Certification (10/16) DGT ◎ Phase II of MRA implementation Limitations of a RCB(2/2) o Subcontract certification work to non-accredited CAB or qualified person o Commit any improper competitive means which is likely to impede regular certification or fair competition, such as boycott, deviated from regulations or participating in a combination or a concerted action o Approve a TE application not listed on the list authorized by DGT o Perform actively market surveillance subject to products certified by other RCBs 63

Mutual Recognition of Certification (11/16) ◎ Phase II of MRA implementation Scopes of Accreditation Mutual Recognition of Certification (11/16) ◎ Phase II of MRA implementation Scopes of Accreditation (1/4) n PSTN Telecommunications Terminal Equipment (PSTN 01, RTTE 01, ID 0002, ADSL 01) Telephone set Modem Automatic alarming equipment Caller ID equipment Modem PBX Telephone answering machine KTS Telephone microphone CTI Fax (Facsimiles) machine Remote control device 46/49 MHz Cordless Telephone 2. 4 GHz RF TTE DS 1 terminal equipment ADSL Terminal Equipment and POTS Splitter 64 DGT

Mutual Recognition of Certification (12/16) DGT ◎ Phase II of MRA implementation Scopes of Mutual Recognition of Certification (12/16) DGT ◎ Phase II of MRA implementation Scopes of Accreditation (2/4) n ISDN Telecommunications Terminal Equipment (IS 6100) ISDN digital phone ISDN G 4 fax machine ISDN video phone ISDN terminal adapter ISDN PC add-on card ISDN PABX other ISDN CPEs n S-PCN Telecommunications Terminal Equipment (IS 2019) 1. 6/2. 4 GHz Satellite Personal Communications Networks (S-PCN) Mobile Earth. Stations (MESs) 65

Mutual Recognition of Certification (13/16) DGT ◎ Phase II of MRA implementation Scopes of Mutual Recognition of Certification (13/16) DGT ◎ Phase II of MRA implementation Scopes of Accreditation (3/4) n PLMN Telecommunications Terminal (PLMN 01~PLMN 08) Paging Receiver Radio terminal equipment Mobile Data Radio Terminal Equipment Trunked Radio Terminal Equipment 1900 MHz Digital Low Tier PHS Radio Terminal Equipment 1900 MHz Digital Low Tier PACS Radio Terminal Equipment 1880 -1895 MHz Wireless Private Branch Exchange and Radio Terminal Equipment GSM Mobile Terminal Equipment DCS 1800 Mobile Terminal Equipment The Third Generation Mobile Telecommunication Terminal Equipment Subscriber A CT-2 wireless PABX system consists of PABX, control equipment (orrelated equipment), CT-2 base station and handset Subscriber B CT-2 wireless PABX system consists of control equipment (or related equipment), CT-2 base station and handset 66

Mutual Recognition of Certification (14/16) DGT ◎ Phase II of MRA implementation Scopes of Mutual Recognition of Certification (14/16) DGT ◎ Phase II of MRA implementation Scopes of Accreditation (4/4) n Low-Power Radio-frequency Devices (LP 0002) Devices operating in the frequency band below (including) 1 GHz Devices operating in the frequency band above 1 GHz except for Unlicensed National Information Infrastructure Devices, frequency hopping or digitally modulated devices Device employing frequency hopping or digital modulation techniques or Unlicensed Information Infrastructure Devices 67 National

Mutual Recognition of Certification (15/16) DGT ◎ Phase II of MRA implementation Limitation on Mutual Recognition of Certification (15/16) DGT ◎ Phase II of MRA implementation Limitation on Certain Scopes o Device for its test procedures are not available or not standardized can’t be approved by a RCB o Devices for which test items and standards are not available can’t be approved by a RCB 68

Mutual Recognition of Certification (16/16) DGT ◎ Phase II of MRA implementation CAB Reassessment Mutual Recognition of Certification (16/16) DGT ◎ Phase II of MRA implementation CAB Reassessment and Surveillance o Testing Laboratories â Regular reassessment by the accreditation body CNLA/TAF as per CNLA reassessment schedule o Certification Bodies ã ã DGT: Irregularly audit CNAB/TAF: Regular reassessment as per accreditation program for CBs 69

Approval Regulatory Framework DGT More information For more detailed information on the contents of Approval Regulatory Framework DGT More information For more detailed information on the contents of the presentation, please visit the following web sites: http: //www. dgt. gov. tw/English/Regulations/Regulatio ns. shtml Contact person: Gin-Shian Lou Email: [email protected] gov. tw Fax: 886 -2 -2343 -3699 70

Approval Regulatory Framework Thank you 71 DGT Approval Regulatory Framework Thank you 71 DGT