1 WORKSHOP “The Regulatory System for Importing Electrical /electronical Goods to Japan” on 2010-06-29 in Tel Aviv by Kurt K. Heinz NCB TÜV Rheinland Japan
Dec 23, 2015
1
WORKSHOP
“The Regulatory System for Importing
Electrical /electronical Goods to Japan”on
2010-06-29
in
Tel Aviv
by
Kurt K. Heinz
NCB TÜV Rheinland Japan
2
Contents:
1. Electrical Appliance and Material Safety Law(DENAN Law)
2. New Pharmaceutical Affairs Law (PAL)
3. Test and Certification for Telecommunication Products
4. Supplemental explanation on Japanese regulations
3
1. Electrical Appliance and Material Safety Law (DENAN Law)
4
Explanation for “Denki Yōhin” - Electrical Appliance and Materials Explanation for “Denki Yōhin” - Electrical Appliance and Materials
In the DENAN, ”Denki Yōhin” is classified into two categories -- “Category A” and “Category B” In the DENAN, ”Denki Yōhin” is classified into two categories -- “Category A” and “Category B”
Category A product : Need to obtain “Certificate of Conformity (CoC) by Registered Conformity Assessment Body (RCAB) = Registered by Japanese Government.
Category A product : Need to obtain “Certificate of Conformity (CoC) by Registered Conformity Assessment Body (RCAB) = Registered by Japanese Government.
Category B product : Not necessary to get CoC, but there is the obligation to conform to the Technical Requirements stipulated by the Ministerial Ordinance. Self- verification (confirmation) can be done by manufacturer.
Category B product : Not necessary to get CoC, but there is the obligation to conform to the Technical Requirements stipulated by the Ministerial Ordinance. Self- verification (confirmation) can be done by manufacturer.
NOTE: There are many other products not being in scope of DENAN Law. And, even if subjecting to DENAN, there are also products being in scope of another regulation, e.g., therapeutic apparatus for households use, microwave oven, etc.
NOTE: There are many other products not being in scope of DENAN Law. And, even if subjecting to DENAN, there are also products being in scope of another regulation, e.g., therapeutic apparatus for households use, microwave oven, etc.
1. Electrical Appliance and Material Safety Law (DENAN)
5
DENAN - Concept of Denki Yōhin** “Denki Yōhin” = The products specified by “DENAN”
DENAN - Concept of Denki Yōhin** “Denki Yōhin” = The products specified by “DENAN”
Category B products
(other electrical appliance and materials)
Total : 339 items
Category A Products
(specified electrical appliance and materials)
Total : 115 items
“Denki Yōhin”
= Electrical Appliance and Materials
Category A and Category B
Total : 454 items
1. Electrical Appliance and Material Safety Law (DENAN)
6
Products controlledby DENAN
Category A products
115 items
Category Bproducts
339 items
Products not controlledby DENAN
Other
electrical products
which are
not in scope of DENAN
(but, may be in scope of
other regulations,
e.g., Radio Law,
Pharmaceutical
Affairs Law, etc.)
Electrical products in Japanese marketElectrical products in Japanese market
1. Electrical Appliance and Material Safety Law (DENAN)
7
In the DENAN Scope?In the DENAN Scope?
Mobile PhoneMobile Phone
Out of Scope of DENAN Out of Scope of DENAN
Why?
Because it is powered by a battery.
Why?
Because it is powered by a battery.
1. Electrical Appliance and Material Safety Law (DENAN)
8
Power Supply Device with DC OutputPower Supply Device with DC Output
Category A
AC Electrical Appliance
DC Power Supply Unit
Category A
AC Electrical Appliance
DC Power Supply Unit
In the DENAN Scope?In the DENAN Scope?
1. Electrical Appliance and Material Safety Law (DENAN)
9
Power Supply Device without EnclosurePower Supply Device without Enclosure
Out of Scope of DENAN Out of Scope of DENAN
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?In the DENAN Scope?
10
Extension Cord SetExtension Cord Set
Category A
Wiring Devices
Multi Tap, Cord, Attachment Plug (respective part)
Category A
Wiring Devices
Multi Tap, Cord, Attachment Plug (respective part)
In the DENAN Scope?In the DENAN Scope?
1. Electrical Appliance and Material Safety Law (DENAN)
11
Coffee MakerCoffee Maker
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?In the DENAN Scope?
Category B
Electrical Heating Appliance
Electric Coffee Maker
Category B
Electrical Heating Appliance
Electric Coffee Maker
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Hair DryerHair Dryer
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?In the DENAN Scope?
Category B
Electrical Motor Operated Appliance
Electric Hair Dryer
Category B
Electrical Motor Operated Appliance
Electric Hair Dryer
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1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?In the DENAN Scope?
Category B
Electronic Appliance
Other Audio Equipment
Category B
Electronic Appliance
Other Audio Equipment
DVD PlayerDVD Player
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1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?In the DENAN Scope?
RefrigeratorRefrigerator
Category B
Electrical Motor Operated Appliance
Electric Refrigerator
Category B
Electrical Motor Operated Appliance
Electric Refrigerator
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1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?In the DENAN Scope?
Massage ChairMassage Chair
Category A
Electrical Motor Operated Appliance
Electric Massager
Category A
Electrical Motor Operated Appliance
Electric Massager
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1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?In the DENAN Scope?
Paper ShredderPaper Shredder
Category A
Electrical Motor Operated Appliance
Shredder
Category A
Electrical Motor Operated Appliance
Shredder
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1. Electrical Appliance and Material Safety Law (DENAN)
Conformity Assessment
OK OK
Product Evaluation ( Safety & RFI)
Survey fortest equipmentof manufacturer
Issue of CoC
Need both compliances
For Category A productFor example: DC Power Supply Unit
Select Technical Requirement : Clause 1 or Clause 2
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1. Electrical Appliance and Material Safety Law (DENAN)
Product Evaluation
Safety related RFI related (if required)
Category A product+
Category B product
Technical requirement Ordinance Clause 1
Technical requirement Ordinance Clause 2
Technical requirement Ordinance Clause 1
Technical requirement Ordinance Clause 2
Selection
NOTE:
Clause 1: Japanese original, requirements existing by each designated product
Clause 2: based on international standards
RFI test is part of Technical Requirements, but not for all.
NOTE:
Clause 1: Japanese original, requirements existing by each designated product
Clause 2: based on international standards
RFI test is part of Technical Requirements, but not for all.
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1. Electrical Appliance and Material Safety Law (DENAN)
Applicable Technical Requirements / Standards Applicable Technical Requirements / Standards
Products specified by “DENAN Law” should be tested in accordance with the technical requirements /standards specified by MITI Ordinance Clause 1 or 2
MITI Ordinance for Technical requirements
Technical requirements
Appendix 1-8
( Remarks )Not only Safety requirements but also RFI requirements are included.
Technical requirements
Appendix 1-8
( Remarks )Not only Safety requirements but also RFI requirements are included.
MITI Ordinance for Technical requirements
MITI Ordinance Clause 2 MITI Ordinance Clause 2 MITI Ordinance Clause 1 MITI Ordinance Clause 1
Technical requirements
J-IEC standards
( Remarks )Not only Safety requirements but also RFI requirements are included.
Technical requirements
J-IEC standards
( Remarks )Not only Safety requirements but also RFI requirements are included.
Selection Possible( Chose one )
Technical Requirements consist of two standard groups :
Category A products / Category B products are required to be tested according to the following standards.
(Either Clause 1 or Clause 2) Need to be in compliance with either Clause 1 or Clause 2.
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1. Electrical Appliance and Material Safety Law (DENAN)
Is your product in question in the
DENAN Law scope???
YES
No
Is your product Category A ?or Category B ?
Out of Scope ofDENAN Law
Category A
product
Category B
product
Japanese Mfr.
Overseas Mfr.
Flow-Chart (A)Flow-Chart (A)
Flow-Chart (B)Flow-Chart (B)
Flow-Chart (C)Flow-Chart (C)
Flow-Chart (D)Flow-Chart (D)
Important!
Overseas Mfr.
Japanese Mfr.
The Law does not apply
DENAN FlowchartDENAN Flowchart
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1. Electrical Appliance and Material Safety Law (DENAN)
Conformity assessment (Mandatory) by RCAB Overseas
nations Mfr. who produces Category A product
Overseas Mfr.Overseas Mfr.
Application
Pass
■Product Test according to Technical Requirement
Clause 1 or Clause 2(Safety / RFI )
■Obligation to keep “CoC” (copy)
■Obligation to check conformity withtechnical requirements■Obligation to make and keep inspection records■ Obligation for marking; “Notifying Supplier’s name” + ”RCAB’s name” +
Obligation of Japanese Importer
( As Notifying Supplier )
Japanese
importer
Business relation
Request for CoC
Japanese ImporterJapanese Importer
“Submittal of CoC -Authorized Valid Copy
Overseas Mfr. / Japanese importer for Category A products
“Issue of CoC”
■Factory Inspection
Site/facility check
Business relation
Need to fulfill the obligation as
Notifying Supplier
DENAN Flowchart (B)DENAN Flowchart (B)
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1. Electrical Appliance and Material Safety Law (DENAN)
Obligation to conform to Technical requirements
Overseas manufacturersOverseas manufacturers
Submittal of the evidenceof compliance
Japanese
importer
Overseas Mfr.
who produces “Category B” product
Japanese ImporterJapanese Importer
Business relation
Business relation
selection
■Obligation to check conformity withtechnical requirements■Obligation to make and keep inspection records■ Obligation for marking; “Notifying Supplier’s name” +
Overseas Mfr. / Japanese importer for Category B products
Obligation of Japanese Importer
( As Notifying Supplier )
Confirmation
Overseas Mfr. can apply to 3rd party testing body for compliance testing (not mandatory = voluntary)
■Product Test according to Technical Requirement Clause 1 or Clause 2 (Safety / RFI )
Compliance check by Mfr. by themselves
■Product Test according to Technical Requirement Clause 1 or Clause 2 (Safety / RFI )
3rd partytesting
Need to fulfill the obligation as
Notifying Supplier
Self confirmation
DENAN Flowchart (D)DENAN Flowchart (D)
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Audit / Registration Report upon request
Notification of starting business
Issue of CoC
Issue of CoC
Issue of CoC equivalent
Request for CoC (Application)
Request for CoC
(Application)
Request for CoC equivalent (Application)
Manufacturer
Category A Products
ImporterCategory A Products
Legal action if necessary
Legal action if necessary
RegisteredConformity Assessment Body
Registration byMETI
Ministry of Economy, Trade and Industry
(METI)
Overseas manufacturer (category A product) =(outside Japan)
Notifying Supplier
Submit of CoC equivalent
Request for CoC equivalent
Notification of starting business
1. Electrical Appliance and Material Safety Law (DENAN)
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1. Electrical Appliance and Material Safety Law (DENAN)
Legal marks stipulated by DENAN Law in JapanLegal marks stipulated by DENAN Law in Japan
There are two kinds of legal marks; one for specified electrical appliances and materials and another for other electrical appliances and materials.
There are two kinds of legal marks; one for specified electrical appliances and materials and another for other electrical appliances and materials.
Marking for Category A (specified electrical appliances and materials )For electric cables/cords, fuses, wiring devices etc, if there is not enough space for marking, manufacturers, etc. it may be marked as “<PS>E” instead of this Mark.
Marking for Category B ( other electrical appliances and materials ) (those not specified in Category A) For electric cables/cords, conduits and its accessories, fuses, wiring devices etc, if there is no enough space for the notifying supplier’s name, it may be marked as “(PS)E” instead of this Mark.
Notifying Supplier’s name and RCAB name who conducted the “Conformity Assessment” have to be indicated near the PSE-diamond mark.
Notifying Supplier’s name has to be indicated near the PSE-Circle mark.
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1. Electrical Appliance and Material Safety Law (DENAN)
About METI HP: Information of DENAN is available in http://www.meti.go.jp/english/policy/economy/consumer/pse/index.htmlThe following is an example of information available on the above HP.
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PharmaceuticalAffairsLaw
薬事法
YakuMedicineJiissue, topicHō law
2. New Pharmaceutical Affairs Law (PAL)
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2. Pharmaceutical Affairs Law (PAL)
The New PAL – Introduction and OverviewThe New PAL – Introduction and Overview
Pharmaceutical Affairs Law (PAL, ‘Yakujihō’)
Revised by the MHLW effective since 2005-04-01
http://www.mhlw.go.jp/
Article 1:
This law is intended to provide regulations required to ensure the quality, efficacy and safety of drugs, quasi-drugs, cosmetics and medical devices and to improve the public health and hygiene through necessary measures taken to promote the research and development of drugs and medical devices which are of particular importance to the medical practice.
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2. Pharmaceutical Affairs Law (PAL)
The New PAL – Introduction and OverviewThe New PAL – Introduction and Overview
NEW:
Review of the Safety Measures for Medical Devices
New System of Medical Devices Classification
Product Certification of the Designated Controlled Medical Devices (Class II) by Registered Certification Bodies(RCBs)
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2. Pharmaceutical Affairs Law (PAL)
New System of Medical Devices ClassificationNew System of Medical Devices Classification
[General Medical Devices]
– Class I, extremely low risk Potential risk is almost insignificant in case of malfunction or side effect.Examples: scalpel, X-Ray film
[(Designated) Controlled Medical Devices]– Class II, low risk Having potential risk in case of malfunction or side effect. Examples: MRI, electronic sphygmomanometers, gastric catheters
[Specially Controlled Medical Devices]– Class III / IV, middle/high risk Potential risk is significant in case of malfunction or side effect. Examples: dialyzer, pacemaker, stent
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2. Pharmaceutical Affairs Law (PAL)
Product Approval/CertificationProduct Approval/Certification
Classification by PAL
Class III Class IVClass IIClass I
Specially ControlledMD
(Designated)Controlled MD
General MD
by MHLW (Application to PMDA)
by RCBno
requirements
Product Certification Product Approval
• RCB: Registered Certification Body
(Designated) Controlled MD: Designated with certain criteria by MHLW
• PMDA: Pharmaceuticals and Medical Devices Agency (Independent Agency of the MHLW)
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2. Pharmaceutical Affairs Law (PAL)
Necessary Approvals / RegistrationsNecessary Approvals / Registrations
Marketing Authorization Holder (MAH)
- Resposible for distribution, quality of the product and manufacturing
- Responsible for vigilance system
Manufacturer (Manufacturing site)
- Manufactures the products upon the order from MAH, products can be sold only to MAH or Manufacturer
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License to Marketing Authorization
MAH, (Marketing Approval Holder)
Domestic factory
Overseas factory
OEM factory
Sales office
distributor
hospial
QA function
Supervising function
Post-marketing safety measures function
Marketing Authorization Holder
QC compliant with the revised QMS(GMP) (ISO 13485 )
productsGQP: Good Quality Practice
GVP: Good Vigilance Practice
(manufacturing Site )
(retail business)
Info
GVP supervision
GQP supervision
33
2. Pharmaceutical Affairs Law (PAL)
Marketing Authorization SystemMarketing Authorization System
1. ‘License to Marketing Business’ MAH Marketing Authorization Holder
2. ‘License (Registration) for Manufacture‘ Production License (-Registration)
3. ‘Device Approval (MHLW) / Certification (RCB)‘ Product Approval / Certification
34
2. Pharmaceutical Affairs Law (PAL)
Special Rules for Foreign ManufacturersSpecial Rules for Foreign Manufacturers
- A foreign manufacturer who intends to getproduct approval or product certificate:
Appointment of the Appointed/Designated MAH (D-MAH) in Japan (needs the corresponding license).
Appointed/Designated MAH(D-MAH) may be:
(1) Distributor
(2) Third party
(3) Company’s subsidiary in Japan
35
2. Pharmaceutical Affairs Law (PAL)
License to Marketing Authorization Holder (MAH) License to Marketing Authorization Holder (MAH)
- Classification of the MAH Licenses
(License for Marketing Authorization Holders) Article 12
Classification by PAL
Class III Class IVClass IIClass I
Specially ControlledMD
DesignatedControlled MD
General MD
Type of Marketing Authorization Holders
No. 3 Type No. 2 TypeNo. 1 Type License for Marketing
Business of Medical Devices
36
2. Pharmaceutical Affairs Law (PAL)
License to Marketing Authorization Holder (MAH) License to Marketing Authorization Holder (MAH)
-MAH has to be in Japan-Classification of the licenses (for MDs, type 1, 2 & 3)
-MAH license renewal: every 5 years (PAL, Article 12, 2.)-Requirements for MAH (e.g. GQP - Good Quality Practice, GVP – Good Vigilance Practice)
-Appointment of a MAH ‘Marketing Supervisor-General’ (responsible person for quality control and market surveillance). Qualification requirements of Marketing Supervisor-General : depending on the product category (MHLW Ordinance)
37
2. Pharmaceutical Affairs Law (PAL)
License (Registration) for ManufactureLicense (Registration) for Manufacture
‘License for Manufacture’ is required for all production sites (also abroad, with the exception of component suppliers)
Depending on the category of the license, the building and it‘s equipment are subject to different requirements.
- Manufacture license categories: Type No. 1 ‘Animal Origin Devices’ (PAL, Article 43)
Type No. 2 ‘Sterile Devices’Type No. 3 ‘Other than No.1 and No.2(Other general devices)Type No. 4 ‘License for Labeling, Packaging and storage
- Foreign manufacturers do not obtain a „manufacture license“ with other words: an „Accreditation“ of all production sites
38
2. Pharmaceutical Affairs Law (PAL)
License (Registration) for ManufactureLicense (Registration) for Manufacture
PAL: (License for Manufacture)Article 13
- The License has to be renewed every 5 years.- Building and equipment must comply with the standards given by MHLW
Ordinance # 180
Article 13-2 Inspection and registration is done by Prefecture and PMDA (Pharmaceuticals and Medical Devices Agency). These organizations reserve the right to do an Inspection/Audit on-site.
39
2. Pharmaceutical Affairs Law (PAL)
Requirements of License (Registration) for ManufactureRequirements of License (Registration) for Manufacture
- Inspection of Buildings and Facilities of Manufacturers: Building and equipment must comply with the standards given by MHLW
Ordinance # 180- Quality System Inspection (QMS Ordinance No.169) is required
PMDAPrefectureOthers
PMDAPMDACell/tissue derivedMedical Device
PMDAPrefectureOthers
PMDAPMDARadioactiveIVD
Foreign Manufacturer(Accreditation)
Domestic(License)
Category
40
2. Pharmaceutical Affairs Law (PAL)
Accreditation of Foreign Manufacturer by PMDAAccreditation of Foreign Manufacturer by PMDA
- A person intending to manufacture in a foreign country drugs or medical devices etc. that are imported to Japan may be accredited by the Minister as a foreign manufacturer.
- Accreditation is granted for each site according to the categories.
- Accreditation shall be renewed every 5 years.
41
2. Pharmaceutical Affairs Law (PAL)
Product Approval Procedure under PALProduct Approval Procedure under PAL
- Approval (Shōnin) of Medical Device by PMDA
- Certification (Ninshō) of Medical Device by RCB (Registered Certification Body )
42
2. Pharmaceutical Affairs Law (PAL)
Product Approval/Certification SystemProduct Approval/Certification System
Classification by PAL
Class III Class IVClass IIClass I
Specially ControlledMD
(Designated)Controlled MD
General MD
by MHLW (Application to PMDA)
by RCBno
requirements
Product Certification Product Approval
• RCB: Registered Certification Body
- alltogether 14, out of that only 3 RCB accredited for all 400 product categories (> 700 products)
• PMDA: Pharmaceuticals and Medical Devices Agency (Independent Agency of the MHLW)
43
2. Pharmaceutical Affairs Law (PAL)
Certification Process by Third Party Certification (RCB) SystemCertification Process by Third Party Certification (RCB) System
② Document Review
Applicant
MAHPost Market Requirement
Conformity (GVP)
Quality Assurance Item Conformity
( GQP)
Manufacturing Site
( Manufacturer )
Facility Structure Criteria
Mfg Control / Quality Control
( GMP/QMS)
• Certification Applicant• Evidence for Criteria Conformity•Self Declaration of Criteria Conformity
① Certification Application
Registered CertificationBody
Audit accordance with ISO IEC 17021
Document evaluation based on
individual conformity criteria
of product
④ Certification (Product)
• On-Site / Doc Audit for conformity to ordinance 169. Confirm evidence related to criteria conformity as needed
③ On-Site or Doc Audit
⑤ Follow-up Audit (After Certification)• Follow-up Audit related to Ordinance
169(GMP/QMS) Conformity once a year
44
2. Pharmaceutical Affairs Law (PAL)
License (Registration) for ManufactureLicense (Registration) for Manufacture
Registration of the Production Site:
• Overview/technical drawings of the buildings and the equipment
• Resumee of the management representative
• List of the manufactured products
• Manufacturing process
• Copies of existing licenses, approval or certificates
Attachments: • Name of the manufacturer
• Address
• Registration category
• Attachment for buildings and equipment
• Name & private address of the management representative
• Name & address of the applicant (could be foreign manufacturer or MAH)
Application:
45
2. Pharmaceutical Affairs Law (PAL)
How to put your products on the Japanese market Product Approval/Certification Steps for Foreign Manufacturers
How to put your products on the Japanese market Product Approval/Certification Steps for Foreign Manufacturers
1. Appointment of the Appointed/Designated MAH (DMAH) in Japan
2. Accreditation of the production facility by PMDA
3. Application for product approval (via DMAH or directly)a) Class II: to RCBb) Class III, IV: to PMDA
- RCB/PMDA reviews the product application documents and checks the QMS(GMP) compliance (on-site Audit or Document Review of manufacturing facilities)
46
2. Pharmaceutical Affairs Law (PAL)
ReferencesReferences
Revision of the Pharmaceutical Affairs Regulations 2002Edition by Pharmaceutical Affairs Study GroupYakuji Nippon Ltd.ISBN 4-8408-0726-4
The Pharmaceutical Affairs Law- New Regulations Effective in 2005 - Edited by The Japan Federation of Medical Devices AssociationsYakuji Nippon Ltd. (www.yakuji.co.jp/e/publications/ )ISBN 4-8408-0773-6
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3. Test and Certification for Telecommunication Products
48
3. Test and Certification for Telecommunication Products
Wired Products Telecommunication Business Law
Radio Products Radio Law
Regulatory Scheme in Japan Regulatory Scheme in Japan
49
Certification Scheme in Japan Certification Scheme in Japan
Radio ProductsWired Products
Telephone FAX PBX ISDN
Terminal PC
etc.
Bluetooth Wi-Fi ZigBee Low Power
security
etc.
Cellular Phone
Cordless Telephone
Wireless LAN
Telecommunication Business Law
Radio Law
Home Electric
AC Adapter etc.
Pump etc.
DENAN Law (Safety)
3. Test and Certification for Telecommunication Products
50
Flow of Radio/Telecom Products Certification by CB and SDOC Flow of Radio/Telecom Products Certification by CB and SDOC
By CB
①Test Certification ②Type Approval
CB
Product Certificate
Test and Document
Judgment
Indication
InvestigationTest and
Document
Judgment
Bring to Market
Type Approval
Certificate
Design Conformity
Data Preservation
Indication
MIC
Applicant
Test and Document
Verification Preservation
Design Conformity
Data Preservation
IndicationBring to Market
Publicatio
n
Effectiveness of Certification and Obligation
By SDOC
3. Test and Certification for Telecommunication Products
51
3. Test and Certification for Telecommunication Products
Test Certificate and Type Approval Test Certificate and Type Approval
1) Test Certificate
Every radio product will be tested and certified based on Radio Law. This scheme is applicable for sample radio products or field trial purpose. Each radio has to affix the unique certification number and certification mark on it.
2) Type Approval
The certificate covers all products manufactured based on the designs or the types and one typical radio product will be tested based on Radio Law. Each radio product has to affix the certification number and mark on it. This scheme is applicable to the mass production product.
52
3. Test and Certification for Telecommunication Products
Group-1: 17 radio facilities (based on Radio Law 38-2-1)No Radio operation license requiredCordless telephone, Low power security, 2.4GHz Data comm.,5GHz Data comm., PHS telephone, etc.
Group-2: 31 radio facilities (based on Radio Law 38-2-2)Covered by Blanket license Cell Phone ( PDC 、 CDMA 、 WCDMA, WiMAX) 、 5GHz
Radio Access, Portable Earth Station, etc.
Group-3: 75 radio facilities (based on Radio Law 38-2-3)Radio operation license required Digital Radio, F3E Radio, Cellular Base
Station ( PDC 、 CDMA 、 WCDMA, WiMAX), PHS Base Station, 5GHz Radio Access Base Station, Several Radar systems, Several Earth Stations , etc.
Specific Radio Facility Specific Radio Facility
53
3. Test and Certification for Telecommunication Products
Specific Telecom Facility Specific Telecom Facility
Chapter 3 Safety, etc. (Articles 4 through 9)Chapter 4 Terminal Facilities to be Connected to Telephone Circuit Facilities
Analog Telephone Terminals (Articles 10 through 16)Mobile Telephone Terminals (Articles 17 through 32)
Chapter 5 Terminal Facilities to be Connected to Radio Paging CircuitFacilities (Articles 33 and 34)Pager
Chapter 6 Terminal Facilities to be Connected to Integrated Services DigitalNetwork (ISDN) Circuit Facilities (Articles 34-2 through 34-6)ISDN Terminal Adapter
Chapter 7 Terminal Facilities to be Connected to Private Circuit Facilities orDigital Data Transmission Facilities (Articles 34-7 and 34-8) 10BaseT/100Base-TX, ADSL, Packet data (mobile), HSDPA, EVDO, DOCSIS 2.0, etc
54
3. Test and Certification for Telecommunication Products
Certification Mark and Number Certification Mark and Number
R 005YAA0000
AD01-0000 005
Radio
Telecom
R: Radio005: CB number of TUV Rheinland JapanYAA: Type of radio equipment 0000: Serial number
AD: Type of telephone01: Year0000: Serial number005: CB number of TUV Rheinland Japan
55
3. Test and Certification for Telecommunication Products
Drawing of label (example) Drawing of label (example)
005WWCAXXXX
Diameter of Telecom Mark is specified,
5mm or more for the product volume being 100cc or more,
3mm or more for the product volume being less than 100cc.
Diameter of Telecom Mark is specified,
5mm or more for the product volume being 100cc or more,
3mm or more for the product volume being less than 100cc.
Bluetooth MouseManufactured by XXX company.
20mm
R
12mm
2.4FH1
56
3. Test and Certification for Telecommunication Products
Extreme Low Power Device Extreme Low Power Device
57
3. Test and Certification for Telecommunication Products
Radio Certification Body Accredited by MIC Radio Certification Body Accredited by MIC
Name of CB Number Group Telecom Engineering Center 001 Group -1, -2, -3 in Radio Law 38-2-1 Japan Armature Radio Association 002 Group -1 in Radio Law 38-2-1 DSP Research 003 Group -1, -2, -3 in Radio Law 38-2-1 Chemitox 004 Group -1, -2, -3 in Radio Law 38-2-1 TUV Rheinland Japan 005 Group -1, -2, -3 in Radio Law 38-2-1 RF Technplogy 006 Group -1 in Radio Law 38-2-1 UL Japan 007 Group -1, -2, -3 in Radio Law 38-2-1 Cosmos Corporation 008 Group -1, -2, -3 in Radio Law 38-2-1 TUV SUD Ohtama 010 Group -1 in Radio Law 38-2-1 Zacta Technology Corporation 011 Group -1, -2, -3 in Radio Law 38-2-1TELEFICATION B.V 201 Group -1, -2, -3 in Radio Law 38-2-1CETECOM ICT Services GmbH 202 Group -1, -2, -3 in Radio Law 38-2-1BABT 203 Group -1 in Radio Law 38-2-1 Phoenix Testlab GmbH 204 Group -1, -2, -3 in Radio Law 38-2-1KTL 205 Group -1, -2, -3 in Radio Law 38-2-1EMCCert Dr. Rasek GmbH 206 Group -1, -2, -3 in Radio Law 38-2-1
58
3. Test and Certification for Telecommunication Products
Telecom Certification Body Accredited by MIC Telecom Certification Body Accredited by MIC
Name of CB Number Japan Approval Institute for
Telecommunications Equipment001
DSP Research 003 Chemitox 004 TUV Rheinland Japan 005 Cosmos Corporation 008 TUV SUD Ohtama 010 Zacta Technology Corporation 011TELEFICATION B.V 201CETECOM ICT Services GmbH 202BABT 203Phoenix Testlab GmbH 204KTL 205
59
3. Test and Certification for Telecommunication Products
Information Link related to Radio certificate Information Link related to Radio certificate
Radio Law:
http://law.e-gov.go.jp/htmldata/S25/S25HO131.html
http://www.soumu.go.jp/main_sosiki/joho_tsusin/eng/Resources/laws/radiolaw2003/RL-index.html
Ordinance Regulating Radio Equipment:
http://law.e-gov.go.jp/htmldata/S25/S25F30901000018.html
http://www.tele.soumu.go.jp/resource/e/equ/tech/orre.pdf
Ordinance concerning Technical Regulations Conformity Certification etc. of Specified Radio Equipment:
http://law.e-gov.go.jp/htmldata/S56/S56F04001000037.html
http://www.tele.soumu.go.jp/resource/e/equ/tech/octr.pdf
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4. Supplemental explanation on Japanese regulations
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Supplemental explanation on Japanese regulations (1/2)
Although it depends on the product specifications, concerning the requirements of “Electrical Appliance and Material Safety Law (“DENAN” in Japanese abbreviation)”, “Pharmaceutical Affairs Law”, “Telecommunication Business Law” and “Radio Law”, the following present conditions must be taken into account:
a) Under Radio Law, there are products to which approval by the Minister is required even if it is not categorized under radio products. Examples are microwave oven, induction cooking appliances, ultrasonic cleaners, ultrasonic processing machines, ultrasonic welders, etc. Some of these are also in the scope of DENAN although it depends on the specification.
b) There are a number of products applicable to DENAN and “Pharmaceutical Affairs Law”. Examples are: electric inhalators (heater or motor operated), household heating therapeutic appliances, electric massagers (motor-operated), electric bubble generators for bathtubs (motor-operated), magnetic therapeutic apparatus, electric moxibustion appliances, household therapeutic ray apparatuses, household low frequency therapeutic apparatuses, household ultrasonic therapeutic apparatuses, household ultrashort wave therapeutic apparatuses, producers of medical materials, household electric-potential therapeutic apparatuses, etc.
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Supplemental explanation on Japanese regulations (2/2)
c) Transformers or DC power supply units which are used only for medical equipment and which are in the range specified by DENAN, are in the scope of DENAN but the “Pharmaceutical Affairs Law” does not apply. Detachable power cords are also treated in the same manner.
d) Products subject to DENAN and with telecommunication and/or radio function, are also subject to the “Telecommunication Business Law” and/or “Radio Law” in addition to DENAN. For example: television receivers with modem function for telecommunication and/or radio communication function such as Bluetooth.