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
1
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
2
1. Electrical Appliance and Material Safety Law
(DENAN Law)
3
1. Electrical Appliance and Material Safety Law (DENAN)
Explanation for “Denki Yōhin” -
Electrical Appliance and Materials
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 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.
4
1. Electrical Appliance and Material Safety Law (DENAN)
DENAN - Concept of Denki Yōhin*
* “Denki Yōhin” = The products specified by “DENAN”
Category B products
(other electrical appliance
and materials)
“Denki Yōhin”
Total : 339 items
= Electrical Appliance
Category A Products
(specified electrical appliance
and materials)
Total : 115 items
Category A and Category B
Total : 454 items
5
and Materials
1. Electrical Appliance and Material Safety Law (DENAN)
Electrical products in Japanese market
Products controlled
by DENAN
Products not controlled
by DENAN
Other
Category B
products
electrical products
339 items
not in scope of DENAN
which are
(but, may be in scope of
other regulations,
e.g., Radio Law,
Category A
products
115 items
6
Pharmaceutical
Affairs Law, etc.)
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
Mobile Phone
Out of Scope of DENAN
Why?
Because it is powered
by a battery.
7
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
Power Supply Device with DC Output
Category A
AC Electrical Appliance
DC Power Supply Unit
8
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
Power Supply Device without Enclosure
Out of Scope of DENAN
9
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
Extension Cord Set
Category A
Wiring Devices
Multi Tap, Cord, Attachment Plug (respective part)
10
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
Coffee Maker
Category B
Electrical Heating Appliance
Electric Coffee Maker
11
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
Hair Dryer
Category B
Electrical Motor Operated Appliance
Electric Hair Dryer
12
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
DVD Player
Category B
Electronic Appliance
Other Audio Equipment
13
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
Refrigerator
Category B
Electrical Motor Operated Appliance
Electric Refrigerator
14
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
Massage Chair
Category A
Electrical Motor Operated Appliance
Electric Massager
15
1. Electrical Appliance and Material Safety Law (DENAN)
In the DENAN Scope?
Paper Shredder
Category A
Electrical Motor Operated Appliance
Shredder
16
1. Electrical Appliance and Material Safety Law (DENAN)
Conformity Assessment
For Category A product
For example:
DC Power Supply Unit
Select
Technical Requirement :
Clause 1 or Clause 2
Product Evaluation
（Safety & RFI)
Survey for
test equipment
of manufacturer
Need both compliances
OK
OK
Issue of CoC
17
1. Electrical Appliance and Material Safety Law (DENAN)
Product Evaluation
Safety related
Category A product
+
Category B product
RFI related
(if required)
Technical requirement
Ordinance Clause 1
Technical requirement
Ordinance Clause 1
Technical requirement
Ordinance Clause 2
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.
18
1. Electrical Appliance and Material Safety Law (DENAN)
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
Selection Possible
（Chose one）
MITI Ordinance for Technical
requirements
MITI Ordinance for Technical
requirements
MITI Ordinance Clause 1
MITI Ordinance Clause 2
Technical requirements
Technical requirements
Appendix 1-8
J-IEC standards
（Remarks）
Not only Safety requirements but
also RFI requirements are included.
（Remarks）
Not only Safety requirements but
also RFI requirements are included.
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.
19
1. Electrical Appliance and Material Safety Law (DENAN)
DENAN Flowchart
Important
！
Is your product in
question in the
DENAN Law
scope???
No
Out of Scope of
DENAN Law
The Law does not apply
YES
Category A
product
Is your product
Category A？or
Category B？
Category B
product
Japanese Mfr.
Flow-Chart (A)
Flow-Chart (C)
Japanese Mfr.
Overseas Mfr.
Flow-Chart (B)
Flow-Chart (D)
Overseas Mfr.
20
1. Electrical Appliance and Material Safety Law (DENAN)
Overseas Mfr. / Japanese importer
DENAN Flowchart (B)
for Category A products
Request for CoC
Overseas
nations Mfr.
who produces
Category A
product
Japanese
importer
Business
relation
Conformity assessment
(Mandatory) by RCAB
Application
■Product Test according
to Technical Requirement
Clause 1 or Clause 2
(Safety / RFI )
Pass
Obligation of
Japanese Importer
■Factory Inspection
Site/facility check
“Issue of CoC”
（As Notifying Supplier）
■Obligation to keep “CoC” (copy)
■Obligation to check conformity with
technical requirements
■Obligation to make and keep
inspection records
■ Obligation for marking;
“Notifying Supplier’s name”
+ ”RCAB’s name” +
21
Overseas Mfr.
Need to fulfill the
obligation as
Notifying Supplier
Business
relation
“Submittal of CoC Authorized Valid Copy
Japanese Importer
1. Electrical Appliance and Material Safety Law (DENAN)
Overseas Mfr. / Japanese importer
for Category B products
DENAN Flowchart (D)
Obligation to conform to Technical requirements
Confirmation
Japanese
importer
Overseas Mfr.
who produces
“Category B”
product
Business
relation
Overseas Mfr. can apply to 3rd party
testing body for compliance testing
(not mandatory = voluntary)
3rd party
testing
■Product Test according to Technical Requirement
selection 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 )
Obligation of
Japanese Importer
（As Notifying Supplier）
■Obligation to check conformity with
technical requirements
■Obligation to make and keep
inspection records
■ Obligation for marking;
“Notifying Supplier’s name” +
Self confirmation
Overseas manufacturers
Need to fulfill the
obligation as
Notifying Supplier
Business
relation
Submittal of the evidence
of compliance
Japanese Importer
22
1. Electrical Appliance and Material Safety Law (DENAN)
Audit / Registration
Report upon request
Notification of
starting business
Manufacturer
Registered
Conformity
Assessment
Body
Registration by
METI
Request for CoC
(Application)
Issue
of
CoC
Request for
CoC
(Application)
Issue
of CoC
Request for CoC
equivalent (Application)
Issue of CoC
equivalent
23
Category A
Products
Legal action
if necessary
Notifying Supplier
Importer
Notification of
starting business
Category A
Products
Request
for CoC
equivalent
Ministry of
Economy,
Trade and
Industry
(METI)
Legal action
if necessary
Submit of CoC
equivalent
Overseas manufacturer
(category A product)
=(outside Japan)
1. Electrical Appliance and Material Safety Law (DENAN)
Legal 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.
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.
Notifying Supplier’s name and RCAB name who conducted the “Conformity Assessment” have to be indicated
near the PSE-diamond 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 has to be indicated near the PSE-Circle mark.
24
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.html
The following is an example of information available on the above HP.
25
2. New Pharmaceutical Affairs Law (PAL)
薬
事
法
26
Yaku
Medicine
Ji
issue, topic
Hō
law
Pharmaceutical
Affairs
Law
2. Pharmaceutical Affairs Law (PAL)
The 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.
27
2. Pharmaceutical Affairs Law (PAL)
The 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)
28
2. Pharmaceutical Affairs Law (PAL)
New 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
29
2. Pharmaceutical Affairs Law (PAL)
Product Approval/Certification
Classification by PAL
Class I
Class II
General
MD
(Designated)
Controlled MD
Class III
Specially Controlled
MD
Product Certification
no
requirements
by RCB
Class IV
Product Approval
by MHLW
(Application to PMDA)
• RCB: Registered Certification Body
(Designated)
Controlled MD: Designated with certain criteria by
MHLW
• PMDA: Pharmaceuticals and Medical Devices Agency
(Independent Agency of the MHLW)
30
2. Pharmaceutical Affairs Law (PAL)
Necessary 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
31
Marketing Authorization Holder
Supervising
License to Marketing
Authorization
function
 MAH, (Marketing Approval Holder)
GQP
supervision
GVP
supervision
QA function
Post-marketing safety
measures function
GQP: Good Quality Practice
products
Info
GVP: Good Vigilance Practice
Sales office
Domestic
factory
Overseas
factory
OEM
factory
(manufacturing
Site )
(retail
business)
distributor
QC compliant with the revised
QMS(GMP) (ISO 13485）
hospial
32
2. Pharmaceutical Affairs Law (PAL)
Marketing 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
33
2. Pharmaceutical Affairs Law (PAL)
Special Rules for Foreign Manufacturers
- A foreign manufacturer who intends to get
product 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
34
2. Pharmaceutical Affairs Law (PAL)
License to Marketing Authorization Holder (MAH)
- Classification of the MAH Licenses
(License for Marketing Authorization Holders)
Article 12
Classification by PAL
Class I
Class II
General
MD
Designated
Controlled MD
Class III
Class IV
Specially Controlled
MD
Type of Marketing Authorization Holders
No. 3 Type
35
No. 2 Type
No. 1 Type License for Marketing
Business of Medical Devices
2. Pharmaceutical Affairs Law (PAL)
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)
36
2. Pharmaceutical Affairs Law (PAL)
License (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
37
2. Pharmaceutical Affairs Law (PAL)
License (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.
38
2. Pharmaceutical Affairs Law (PAL)
Requirements 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
Category
Domestic
(License)
Foreign Manufacturer
(Accreditation)
Radioactive
PMDA
PMDA
Prefecture
PMDA
PMDA
PMDA
Prefecture
PMDA
IVD
Others
Medical
Device
39
Cell/tissue derived
Others
2. Pharmaceutical Affairs Law (PAL)
Accreditation 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.
40
2. Pharmaceutical Affairs Law (PAL)
Product Approval Procedure under PAL
- Approval (Shōnin) of Medical Device
by PMDA
- Certification (Ninshō) of Medical Device
by RCB (Registered Certification Body )
41
2. Pharmaceutical Affairs Law (PAL)
Product Approval/Certification System
Classification by PAL
Class I
Class II
General
MD
(Designated)
Controlled MD
Product Certification
no
requirements
by RCB
Class III
Class IV
Specially Controlled
MD
Product Approval
by MHLW
(Application to PMDA)
• 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)
42
2. Pharmaceutical Affairs Law (PAL)
Certification Process by Third Party Certification (RCB) System
Applicant
MAH
Post Market
Requirement
Conformity (GVP)
Quality Assurance
Item Conformity
（GQP)
Manufacturing
Site
（Manufacturer）
• Certification Applicant
• Evidence for Criteria Conformity
•Self Declaration of Criteria Conformity
① Certification Application
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
Facility Structure
Criteria
Mfg Control /
Quality Control
（GMP/QMS)
43
⑤ Follow-up Audit (After Certification)
• Follow-up Audit related to Ordinance
169(GMP/QMS) Conformity once a year
Registered Certification
Body
② Document Review
Document
evaluation based
on individual
conformity criteria
of product
Audit accordance
with ISO IEC 17021
2. Pharmaceutical Affairs Law (PAL)
License (Registration) for Manufacture
Registration of the Production Site:
Attachments:
• 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
44
Application:
• 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)
2. Pharmaceutical Affairs Law (PAL)
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 RCB
b) 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)
45
2. Pharmaceutical Affairs Law (PAL)
References
Revision of the Pharmaceutical Affairs Regulations 2002
Edition by Pharmaceutical Affairs Study Group
Yakuji Nippon Ltd.
ISBN 4-8408-0726-4
The Pharmaceutical Affairs Law
- New Regulations Effective in 2005 Edited by The Japan Federation of Medical Devices Associations
Yakuji Nippon Ltd. (www.yakuji.co.jp/e/publications/ )
ISBN 4-8408-0773-6
46
3. Test and Certification
for Telecommunication Products
47
3. Test and Certification for Telecommunication Products
Regulatory Scheme in Japan
Wired Products
Telecommunication Business Law
Radio Products
Radio Law
48
3. Test and Certification for Telecommunication Products
Certification Scheme in Japan
Home Electric
 Pump
etc.
 AC
Adapter
etc.
DENAN Law
(Safety)
49
Wired Products




Telephone
FAX
PBX
ISDN
Terminal
 PC
etc.
Radio Products
 Cellular
Phone
 Cordless
Telephone
 Wireless
LAN
Telecommunication
Business Law
 Bluetooth
 Wi-Fi
 ZigBee
 Low Power
security
etc.
Radio Law
3. Test and Certification for Telecommunication Products
Flow of Radio/Telecom Products Certification by CB and SDOC
By CB
①Test Certification
Investigation
Test and
Document
By SDOC
②Type Approval
Applicant
CB
Test and
Document
Judgment
Judgment
Product Certificate
Type
Approval
Certificate
Test and Document
Verification
Indication
Design Conformity
Design Conformity
Bring to
Market
Data Preservation
Indication
MIC
Data Preservation
Pu
blic
atio
n
Effectiveness of Certification and Obligation
50
Preservation
Indication
Bring to
Market
3. Test and Certification for Telecommunication Products
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.
51
3. Test and Certification for Telecommunication Products
Specific Radio Facility
Group-1: 17 radio facilities (based on Radio Law 38-2-1)
No Radio operation license required
Cordless 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.
52
3. Test and Certification for Telecommunication Products
Specific Telecom Facility
Chapter 3
Chapter 4
Chapter 5
Chapter 6
Chapter 7
53
Safety, etc. (Articles 4 through 9)
Terminal Facilities to be Connected to Telephone Circuit Facilities
Analog Telephone Terminals (Articles 10 through 16)
Mobile Telephone Terminals (Articles 17 through 32)
Terminal Facilities to be Connected to Radio Paging Circuit
Facilities (Articles 33 and 34)
Pager
Terminal Facilities to be Connected to Integrated Services Digital
Network (ISDN) Circuit Facilities (Articles 34-2 through 34-6)
ISDN Terminal Adapter
Terminal Facilities to be Connected to Private Circuit Facilities or
Digital Data Transmission Facilities (Articles 34-7 and 34-8)
10BaseT/100Base-TX, ADSL, Packet data (mobile), HSDPA, EVDO,
DOCSIS 2.0, etc
3. Test and Certification for Telecommunication Products
Certification Mark and Number
Radio
R 005YAA0000
R:
005:
YAA:
0000:
Telecom
AD01-0000 005
AD:
01:
0000:
005:
54
Radio
CB number of TUV Rheinland Japan
Type of radio equipment
Serial number
Type of telephone
Year
Serial number
CB number of TUV Rheinland Japan
3. Test and Certification for Telecommunication Products
Drawing of label (example)
20mm
Bluetooth Mouse
Diameter of Telecom
Mark is specified,
2.4FH1
Manufactured by XXX company.
R 005WWCAXXXX
12mm
5mm or more for the
product volume being
100cc or more,
3mm or more for the
product volume being
less than 100cc.
55
3. Test and Certification for Telecommunication Products
Extreme Low Power Device
56
3. Test and Certification for Telecommunication Products
Radio Certification Body Accredited by MIC
Name of CB
Telecom Engineering Center
Japan Armature Radio Association
DSP Research
Chemitox
TUV Rheinland Japan
RF Technplogy
UL Japan
Cosmos Corporation
TUV SUD Ohtama
Zacta Technology Corporation
TELEFICATION B.V
CETECOM ICT Services GmbH
BABT
Phoenix Testlab GmbH
KTL
EMCCert Dr. Rasek GmbH
57
Number
001
002
003
004
005
006
007
008
010
 011
 201
 202
 203
 204
 205
 206
Group
Group -1, -2, -3 in Radio Law 38-2-1
Group -1 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
Group -1, -2, -3 in Radio Law 38-2-1
3. Test and Certification for Telecommunication Products
Telecom Certification Body Accredited by MIC
Name of CB
Japan Approval Institute for
Telecommunications Equipment
DSP Research
Chemitox
TUV Rheinland Japan
Cosmos Corporation
TUV SUD Ohtama
Zacta Technology Corporation
TELEFICATION B.V
CETECOM ICT Services GmbH
BABT
Phoenix Testlab GmbH
KTL
58
Number
001






003
004
005
008
010
011
201
202
203
204
205
3. Test and Certification for Telecommunication Products
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/la
ws/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.
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