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 covers several types of lasers and laser classes and laser applications.

Stakeholders: Manufacturer, Importer, Distributor, Operator, User
Legislation in force: In New Zealand, the protection of the general public from optical radiation is regulated - in the Administrative Regulations: Health (High-Power Laser Pointers) Regulations 2013 enacted pursuant to the Health Act 1956, - in the Administrative Regulations: Customs Import Prohibition (High-Power Laser Pointers) Order 2013, enacted under the Customs and Excise Act 1956, - in the Summary Offenses Act 1981) (Art 13B), - in the Auckland Council Health and Hygiene bylaw 2013) issued by the Auckland Board of Directors which set limit values. Other scenarios will be regulated in purpose dedicated laws and regulations: - in the Health and Safety at Work Act 2015 for workplaces, - in the Electricity (Safety) Regulations 2010 for electrical medical devices, - in the Health and Safety at Work (Mining Operations and Quarrying Operations) Regulations 2016 for mining operations. Health and Safety at Work (Mining Operations and Quarrying Operations) Regulations 2016 Version as at 18 July 2023 Health and Safety at Work Act 2015 Version as at 23 December 2023 Health (High-Power Laser Pointers) Regulations 2013

Application national:

Countries: Image for NZ New Zealand,  
Status: Published 2023-04-20 by Benjamin Kerger and (Marius Galka)
Last change 2024-03-12 by Ina May: Legislation in force for this PCT, Laser general requirements
ROGER WILLCO ID: #5o6n
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Scope of this ESSENTIAL
This ESSENTIAL covers several types of lasers and laser classes and laser applications.'

Analysis of regulatory requirements

Legislation in force for this PCT
Here you will get textual information

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

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)?

Legislation in force for this PCT
Here you will get related hyperlink(s)

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

Scope of legislation
This ESSENTIAL covers several types of lasers and laser classes and laser applications.
- laser at workplaces
- laser at special workplaces, e.g. mines
- laser for treatment
- medical laser
- High-power Laser Pointers
- laser considered being safe (Class 1 and Class 2)'

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 related hyperlink(s)

Exempted devices/products or industry sectors.

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.

Authority
Here you will get related hyperlink(s)

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

FTA/MRA status with EU
Here you will get related hyperlink(s)

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

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?

Market surveillance authority
Here you will get textual information

Name of the authority for market surveillance and/or enforcement

Link/Reference to other reference document(s)
Here you will get related hyperlink(s)

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 textual information

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]

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

Hints
Here you will get related hyperlink(s)

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 related hyperlink(s)

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 related hyperlink(s)

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

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

Link to organisation

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 a image or chart

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

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

Regulated by the legal provisions

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, ContinentNZL, Australia
Economic AreaANZCERTA (FTE with Australia)
Official LanguageEnglish, Maori
Standard InstituteStandards New Zealand | https://www.standards.govt.nz/
HS CodememberYes - since 1963






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