Regulatory ESSENTIAL



Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

Laser; Laser device; Laser safety

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Scope: This ESSENTIAL describes the legal obligations for manufacturers which supply laser products to Japan.

Stakeholders: Manufacturer, Importer, B2C products, B2B products
Legislation in force: Consumer Product Safety Act (Act No. 31) Order No. 18 (1974) Based on the Consumer Product Safety Act (Act No. 31 of 1973) and the Order for Enforcement of the Consumer Product Safety Act (Cabinet Order No. 48 of 1974) The Order of the Ministry of International Trade and Industry No. 18 of March 5, 1974 Ministerial Order on Technical Requirements for Specified Products Related to the Ministry of Economy, Trade and Industry It was changed over the years.

Application national: Laser

Countries: Image for JP Japan,  
Comment on the comparability to EU legislation: Technical identical to EU....
Status: Published 2023-06-29 by Torsten Sahm and Inken Green
Last change 2025-04-08 by Torsten Sahm: Is in-country testing legally required?, Laser general requirements
ROGER WILLCO ID: #jp6s
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Scope of this ESSENTIAL
This ESSENTIAL describes the legal obligations for manufacturers which supply laser products to Japan. '

Abbreviations
Here you will get a table

Important abbreviations which are special for this legislation or theme.

Analysis of regulatory requirements

Legislation in force for this PCT
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation
The Consumer Product Safety Act describes the legal obligations for manufacturers and the regulatory requirements for electronic product radiation as specified in the METI Order 18.

Order 18, appended Table 1, No. 5 in conjunction with JIS C6802 (2011) defines "Portable Laser Application Devices":
Any device that enables the user to confirm that a laser beam is being emitted is a JIS C6802 (2011) Laser Product Safety Standards
3.18 Class 1 Laser Product or
3.20 Class 2 Laser Product
'

Responsible actors
Here you will get textual information

Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
Here you will get textual information

What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses
Here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
Here you will get textual information

E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Has the country signed a Free Trade Agreement (FTA) or a Mutual Recognition Agreement (MRA) with EU?

Authority
Here you will get related hyperlink(s)

Name of the authority for approval, registration, market surveillance and/or enforcement

Market surveillance authority
Here you will get related hyperlink(s)

Name of the authority for market surveillance and/or enforcement

Link/Reference to other reference document(s)
Here you will get textual information

Comment on the comparability to EU legislation
Here you will get textual information

Hints
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Specific recommendations, information or most common mistakes

Hints
Here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
Here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
Here you will get textual information

[Yes/No]

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
Here you will get textual information

Means each legally required approval process prior placing on the market, importation or putting into service

Is the IECEE CB Scheme accepted by the authority/approval body?
Here you will get textual information

"[Yes/ No / no information available] [Text] Information (website)"

Conformance document(s) to show compliance to the authority
Here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
Here you will get textual information

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
Here you will get textual information

e .g. formal application

Is a factory inspection legally required
Here you will get textual information

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing
Here you will get textual information

e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
Here you will get textual information

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment
Here you will get textual information

National Standardisation Organisation
Here you will get related hyperlink(s)

Link to organisation

Are national standards based on IEC/ISO standards?
Here you will get textual information

Undetailed information

Is in-country testing legally required?
Here you will get textual information

Acceptance of foreign test reports
Here you will get textual information

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get textual information

e. g. product label

Regulatory e-labelling allowed?
Here you will get textual information

e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging
Here you will get textual information

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
Here you will get textual information

Regulated by the legal provisions

User instruction requirements and specific compliance notes
Here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Digital user documentation allowed?
Here you will get textual information

User instructions allowed by QR-Code/internet or digital medium or integrated in device with display? Safety instruction allowed by QR-Code or digital medium?

Warnings, symbols
Here you will get textual information

e. g. ANSI Z 535.4

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes


Code, ContinentJPN, Asia
Economic AreaAPEC
Official LanguageThe official language is Japanese.
Standard InstituteJSA - Japanese Standards Association | https://www.jsa.or.jp/en/
HS CodememberYes - since 1964






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