1 WORKSHOP “The Regulatory System for Importing Electrical /electronical Goods to Japan ” on...

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


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


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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.


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



9

Power Supply Device without EnclosurePower Supply Device without Enclosure

Out of Scope of DENAN Out of Scope of DENAN



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)



11

Coffee MakerCoffee Maker



Category B

Electrical Heating Appliance

Electric Coffee Maker

Category B

Electrical Heating Appliance

Electric Coffee Maker

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Hair DryerHair Dryer



Category B

Electrical Motor Operated Appliance

Electric Hair Dryer

Category B


Electric Hair Dryer

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Category B

Electronic Appliance

Other Audio Equipment

Category B

Electronic Appliance

Other Audio Equipment

DVD PlayerDVD Player

14



RefrigeratorRefrigerator

Category B


Electric Refrigerator

Category B


Electric Refrigerator

15



Massage ChairMassage Chair

Category A


Electric Massager

Category A


Electric Massager

16



Paper ShredderPaper Shredder

Category A


Shredder

Category A


Shredder

17


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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Product Evaluation

Safety related RFI related (if required)

Category A product+

Category B product

Technical requirement Ordinance Clause 1




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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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.


Appendix 1-8


MITI Ordinance for Technical requirements

MITI Ordinance Clause 2 MITI Ordinance Clause 2 MITI Ordinance Clause 1 MITI Ordinance Clause 1


J-IEC standards



J-IEC standards


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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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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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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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


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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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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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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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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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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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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


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

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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

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License to Marketing Authorization Holder (MAH) License to Marketing Authorization Holder (MAH)

- Classification of the MAH Licenses

(License for Marketing Authorization Holders) Article 12




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


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)

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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

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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.

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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


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.

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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 )

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Product Approval/Certification SystemProduct Approval/Certification System




(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


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

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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


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


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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48


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)


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


51


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


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

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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


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


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


Extreme Low Power Device Extreme Low Power Device

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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

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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


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.

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