Approval Regulatory Framework
by Gin-Shian Lou
DGT,Chinese Taipei
Email:james@dgt.gov.tw
May 11, 2005
1
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
§48
§48
§39
§39
2003
1999
Telecommunications
電信法
Act
§44
§44
§42
§42
3
§46
§46
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 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 and 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
following:
technical
5
specifications
must
ensure
the
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 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 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 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 radio
frequency device shall be mandated and 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 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
 Compliance Approval Regulations on Controlled
Telecommunications Radio-Frequency Devices
 Compliance Approval Regulations of Telecommunications
Terminal Equipment
 Administration Regulations of Regulatory Certification
Body for Controlled Telecommunications Radio-Frequency
Devices
 Administration Regulations of Regulatory Certification
Body for Telecommunications Terminal Equipment
 Administrative Regulations on the Controlled
Telecommunications Radio-Frequency Devices
 Administrative Regulations on Low Power Radio Waves
Radiated Devices
 Administrative Regulations on Radio Waves of Industrial,
Scientific, Medical Equipment
 LP Device: LP0002(1)
 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
Telecommunications Radio-Frequency Devices
 Administrative Regulations on Low Power Radio Waves
Radiated Devices
 Compliance Approval Regulations on Controlled
Telecommunications Radio-Frequency Devices
 Technical Specifications:
 LP0002: Low Power RF Devices Technical Specifications
13
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 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 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 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
 Technical Specifications:















PLMN01: GSM 900 and DCS1800 Mobile Equipment
PLMN02: 1900MHz Digital Low Tier PHS Radio Terminal Equipment
PLMN03: 1900MHz Digital Low Tier PACS Radio Terminal Equipment
PLMN04: Trunked Radio Terminal Equipment
PLMN05: Mobile Data Radio Terminal Equipment
PLMN06: Paging Receiver Radio Terminal Equipment
PLMN07: 1880-1895MHz Wireless Private Branch Exchange and Radio Terminal Equipment
PLMN08: The Third Generation Mobile Telecommunication Terminal Equipment
PSTN01: Terminal Equipment for Connection to Public Switched Telephone Network
RTTE01: 2.4GHzRadio-frequency Telecommunications Terminal Equipment
ADSL01: Asymmetric Digital Subscriber Line Terminal Equipment and POTS Splitter
ID0002: DS1 Equipment Type Approval Guidelines
IT0002: CT-2 Wireless Private Branch Exchange System Equipment Type Approval Guidelines
IS6100: ISDN Terminal Equipment
IS2019: 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 Regulations of Telecommunications Terminal
Equipment
The Telecommunications Terminal Equipment mentioned 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, Compliance Approval Regulations of Telecommunications Terminal
Equipment
 The
relevant TTE technical specifications shall be formulated and announced in public
by the DGT
 The aforementioned technical specifications shall not only contain test items and
standards, but also ensure the following:
 The connection should not damage telecommunications network facilities of Type I
telecommunications enterprises, or malfunction the said facilities.
 Any nuisance shall not be caused to other users of the telecommunications network
facilities of Type I telecommunications enterprises.
 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.
 The connection of TTE shall ensure it is normally interfaced with the
telecommunications network facilities of Type I telecommunications enterprises.
 Ensure Electro-Magnetic Compatibility (hereinafter as EMC) to harmonize and
effective use of the radio spectrum.
 Ensure electrical safety to prevent harm to network operator personnel or users.
20
Terminal Equipment Technical Regulations (4/9)
◎ Essential Requirements of TTE
Harm to network and users
Electrical safety
Limit to
Electromagnetic Compatibility
21
DGT
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.
 xDSL
 IP Phone
 Cable Modem
 DS1 TTE
 Cellular Phone (IEC/EN 60950, Jan 7, 2004)
22
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:


2G Cell Phone(PLMN 01, Section 3); 3G 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 C95.1 and
ANSI/IEEE C95.3, Std. 1528-200x or the ANSI/IEEE relevant latest
requirements.
23
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 Warning Label:
(PLMN01, Section 3.9; PLMN08, 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 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.
 For 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]
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
Accredited
Testing Labs
Certification Bodies
Comply with
ISO/IEC 17025
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 force in Nov. 2004):


Compliance Approval Regulations
Telecommunications Equipment
on
Controlled
Compliance Approval Regulations of Telecommunications
Terminal Equipment
 Outline of the amendment
 SDoC (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 TTE and LP
Supplier Declaration
of Compliance
(SDoC)
Certification
(Type Approval)
Technical Regulations
29
Conformity Assessment Requirements (3/12 )
DGT
◎ Definition of Type Approval and SDoC for TTE and LP
 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.
 Supplier Declaration of Conformity(SDoC)：
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
Category of Compliance Approval
Sale use
Private use
SDoC
Type
Approval
Approval
by Piece
(For LP device only)
31
DGT
DGT
Conformity Assessment Requirements (5/12 )
◎ Compliance Approval Requirements for TTE and LP
Items for Application Folder
1. Apparatus sample
2. Certificate of origin
3. User Manuel
4. Spec. document
5. Circuit diagram or Block diagram
6. Test Report
7. Certificate of establishment for legal
entity
8. Operation certificate of CTD
9. Other documents specified by DGT
10. Compact Discs including the above
information
11. Qualification document
Sale use
Type approval
Approval by piece
X
X
X
X
X
X (including
frequency and
emission power)
X
X
If necessary
X
X
X(exempt for foreign
manufacturer)
X
X
Private use
X
X
X (including
frequency and
emission power)
If necessary
X(exempt for foreign
manufacturer)
X
X
X
32
Conformity Assessment Requirements (6/12 )
DGT
◎ Elements of Test Report for TTE and LP
 The test report includes:












Color photographs larger than 4R of the unit to show details of external
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
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
 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; JTC1
Regional Standard: ETSI; ANSI; TTC; CEN; T1
34
DGT
Conformity Assessment Requirements (8/12 )
◎ Conformity Assessment Procedure for TTE and LP (Sale Use)
R
T
L
Ap p l i c a n t
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
Yes
Is the supplement
complete and
adequate
No
Is the application
package complete
and adequate?
Yes
No
Turn down the application
Equipment conformity
assessment
Fail
Applicant will receive notification of
failure and shall apply for secondary
review within 2 months
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 (Private Use)
R
Ap p l i c a n t
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
Yes
Yes
No
Turn down the application
Is the application
package complete
and adequate?
No
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
◎ SDoC for TTE and LP
 Planning to the products apply SDoC:
 The products has short life cycle.
 The Products has stable quality and low Safety risks.
 Less impact on consumers
 Starting with small area of products, to see the knowledge and
cooperation manufacturers, importers and distributors have to
meet the certification regulations.
 The items of equipment and date of implementation applicable to
the SDoC 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
◎ SDoC and Registration Requirements for TTE and LP
 Equipment
testing must be performed by DGT recognized
testing laboratories
 Compliance Folder are kept by RCB.
 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
 The Equipment models will be registered by RCB.
38
Conformity Assessment Requirements (11/12 )
DGT
◎ SDoC and Registration Procedure for TTE and LP (1/2)
 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 are
exempted)
–Other documents specified by DGT
–5 Compact Discs including the above information
–Registration fee
39
Conformity Assessment Requirements (12/12 )
DGT
◎ SDoC and Registration Procedure for TTE and LP (2/2)
 Declaring Party action
 RCB action
–Review
for completeness
–Grant Certificate of SDoC
– Register Equipment on the List
–Label
the Equipment
–Distribute the Equipment for
market
 SDoC Mark showed as below:
XxxYYyyy=z
XXXyyyRFDzzzz-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
 The exclusive right of use relating to Approval Label belongs to
the one who has been granted the certificate of approval.
 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.
 Certified equipment shall bear the identifying marks for market.
 The identifying marks shall be affixed to the certified equipment.
41
Marking Requirements (2/6)
◎ Label Empowerment Process
Submission by Certificate Holder
–Authorization
Letter
–Compliance Approval Certificate or SDoC Certificate
–Legal Entity Certificate of Authorized Party
RCB action
–Review
for completeness
–Send acknowledgement to the original certificate
holder
42
DGT
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
XxxYYyyy-z
A : stand for “DGT”
xx : Year Identification
YY : Equipment Category
yyy : Serial No.
z : Certified regulatory station of DGT
-For Private Use:
AxxYYyyy/z
N: Northern Regional Station;
C: Central Regional Station;
S: Southern Regional Station
43
Marking Requirements (4/6)
DGT
◎ Low Power RF Devices Approval Mark
-For Sale Use:
XXX: RCB Identification
yyy : Year Identification
zzzz: Serial No.
x : Identify as series products, a-z
XXXyyyLPDzzzz-x
-For Approval by Piece:
xxx : Year Identification
yyyy: Serial No.
DGTxxxLPDyyyy
-For Private Use:
xxx : Year Identification
y : Certified regulatory station of DGT
zzzz: Serial No.
DGTxxxLPDyzzzz
44
Marking Requirements (5/6)
◎ Warning Label (Indoor Wireless TTE products)
◎ Warning Label (Cellular Phone)
45
DGT
Market Surveillance (1/3)
DGT
 There's a requirement specified that RCBs are to perform
some surveillance of the products they certify
 Each RCB is required to have a market surveillance
program in place to monitor all of the products it certifies
 RCB is being carried out surveillance program mandatory
 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
 DGT/RCB determine whether a certified equipment
maintains conformity with technical standards and the
identity by sampling in the market.
 Surveillance Method
 Electric Characteristics Test
Examine conformity with the technical regulations
 Comparison and Verification
 Identity with color photographs

47
Market Surveillance (3/3)
 Performed by DGT
Randomly
 In response to complaints
 Performed by RCBs
 For apparatus that they have certified

 May result in testing to technical specifications
 Fines will be applied
48
DGT
Mutual Recognition of Test Report (1/5)
DGT
◎ Phase I of MRA implementation
Recognized Testing Lab (RTL)Designation Criteria
 Legal entity which has the technical competence to perform the
tests
 Accredited with ISO/IEC 17025
 Demonstration of technical competence in performing the tests.
 Technological knowledge and experience of relevant product
 Familiar with legislative, regulatory and administrative
provisions
49
Mutual Recognition of Test Report (2/5)
DGT
◎ Phase I of MRA implementation
Domestic RTL Designation Process
 Submit application package to CNLA
 CNLA will review the application package. If it is acceptable,
the process for the accreditation will be undertaken by CNLA
 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.
 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 how to recognize foreign testing lab as the MRA CAB?
 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.
 Then, the Designating Authority of exporting Party will exchange the list
of designated testing lab with DGT for mutual recognition.
 Furthermore, the DGT will recognize the MRA CABs if the testing labs
are competent to perform testing subject to technical regulations of DGT.
 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 test reports how to be accepted by Chinese Taipei (1/2)
 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.
 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:
 Color photographs larger than 4R of the unit to show details of
external 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
52
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)
 Name, trade and model number of testing facilities as well as date of
calibration and period of validity
 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
 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 RCB
 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.
 Administration Regulations of Regulatory Certification Body for

Telecommunications Terminal Equipment
Administration Regulations of Regulatory Certification Body for
Controlled Telecommunications Radio-Frequency Devices
 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 a RCB
 The DGT will form a technical team to accredit the organization
which is interested and competent to be RCB.
 An entity accredited by the DGT will be designated as a RCB.
 The DGT will also recognize a CB designated by a foreign
Designating Authority in accordance with the terms of APEC
Telecom MRA.
 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 Criteria (1/2)
 Legal entity
 Not be a importer, designer, manufacturer, supplier of TTE/LP device nor
being engaged in these activities
 Accredited to ISO/IEC Guide 65
 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
 A foreign RCB shall also equipped with testing lab which demonstrate
competence in performing tests and accredited to ISO/IEC 17025
 Familiar with legislative, regulatory and administrative provisions of
DGT
 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 Criteria (2/2)
 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)
 The personnel involved in the certification process should be
independent from those conduct the testing.
 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.
 The certification personnel is requested to be graduated from the
domestic or foreign university/college and
telecommunications engineering, electrical
electronic engineering or other relevant majors.
57
majored in
engineering,
Mutual Recognition of Certification (5/16)
DGT
◎ Phase II of MRA implementation
How to recognize foreign certification body as the RCB?
 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.
 Then, the Designating Authority of exporting Party will
exchange the list of designated accreditation body with DGT
for mutual recognition.
 Furthermore, the DGT will recognize the MRA CABs if the
certification body are competent to perform certification
subject to technical regulations of DGT.
 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 a RCB (1/3)
A RCB shall-- Certify equipment in accordance with the DGT’s rules in the
name of RCB and in the written form
 Provide fair and equitable treatment
 Send certified products list to DGT
 Perform post-market surveillance activities, under
instructions or request by the DGT
A foreign RCB may appoint a local organization to
perform market surveillance activities.
 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 a RCB (2/3)
 Submit copies of each application package to the DGT
(complete application until the contract is due)
 All application documentation shall be recorded on the CD
and send to DGT for reference.
 Set a electrical database to store all applications and list of
certified product
 Authorize DGT to review all the certified equipment
information stored in the database set up by the RCB via
internet
 Accept MRA CABs test reports
 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 a RCB (3/3)
 Charge fees for processing applications in accordance with
the fees schedule stipulated by the MOTC
 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 a RCB(1/2)
A RCB can not-- Violate the rules
 Refuse audit without acceptable reason
 Default on conducting certification cases
 Overrun the scope not empowered or not listed on the
contract
 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 a RCB(2/2)
 Subcontract certification work to non-accredited CAB or
qualified person
 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
 Approve a TE application not listed on the list authorized by
DGT
 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 (1/4)
 PSTN Telecommunications Terminal Equipment
(PSTN01,RTTE01,ID0002, ADSL01)
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
2.4GHz RF TTE
DS1 terminal equipment
ADSL Terminal Equipment and POTS Splitter
64
DGT
Mutual Recognition of Certification (12/16)
DGT
◎ Phase II of MRA implementation
Scopes of Accreditation (2/4)
 ISDN Telecommunications Terminal Equipment (IS6100)
 ISDN digital phone
 ISDN G4 fax machine
 ISDN video phone
 ISDN terminal adapter
 ISDN PC add-on card
 ISDN PABX
 other ISDN CPEs
S-PCN Telecommunications Terminal Equipment (IS2019)

1.6/2.4 GHz Satellite Personal Communications Networks (S-PCN) Mobile
EarthStations (MESs)
65
Mutual Recognition of Certification (13/16)
DGT
◎ Phase II of MRA implementation
Scopes of Accreditation (3/4)
 PLMN Telecommunications Terminal (PLMN01~PLMN08)
 Paging Receiver Radio terminal equipment
 Mobile Data Radio Terminal Equipment
 Trunked Radio Terminal Equipment
 1900MHz Digital Low Tier PHS Radio Terminal Equipment
 1900MHz Digital Low Tier PACS Radio Terminal Equipment
 1880-1895MHz Wireless Private Branch Exchange and Radio Terminal Equipment
 GSM Mobile Terminal Equipment
 DCS1800 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 Accreditation (4/4)
 Low-Power Radio-frequency Devices (LP0002)
 Devices operating in the frequency band below
(including) 1GHz
 Devices operating in the frequency band above 1GHz
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 Certain Scopes
 Device for its test procedures are not available or
not standardized can’t be approved by a RCB
 Devices for which test items and standards are not
available can’t be approved by a RCB
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Mutual Recognition of Certification (16/16)
DGT
◎ Phase II of MRA implementation
CAB Reassessment and Surveillance
 Testing Laboratories
 Regular
reassessment by the accreditation body
CNLA/TAF as per CNLA reassessment schedule
 Certification Bodies


DGT: Irregularly audit
CNAB/TAF:Regular reassessment as per accreditation
program for CBs
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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: James@dgt.gov.tw
Fax: 886-2-2343-3699
70
Approval Regulatory Framework
Thank you
71
DGT