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.

Boilers; conformity assessment; declaration of conformity; legal obligations; lifting accessories; machinery; placing on the market; putting into service; risk assessment; safety components; special equipment; technical documentation

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Stakeholders: Manufacturer, Importer
Legislation in force: Occupational Safety and Health Act Enforcement Rules of the Occupational Safety and Health Act Safety Standard of Machinery, Equipment and Tools Regulations for Safety Inspection of Hazardous Machines and Equipment (amended November 21, 2016)

Application national:

Countries: Image for TW Taiwan,  
Status: Published 2023-08-18 by Linda Kritzler and Benjamin Kerger
Last change 2024-03-05 by Inken Green: Exemption clauses, Machine safety and guarding
ROGER WILLCO ID: #cy6c
Price 30 day license for 89.00 € NET net

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essentials@globalnorm.de

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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
Here you will get linked document(s)

Scope of legislation
Here you will get related hyperlink(s)

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 linked document(s)

Exempted devices/products or industry sectors.

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

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 textual information

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 related hyperlink(s)

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

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.

Registration at related authority required?
Here you will get related hyperlink(s)

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

Approval process (conformity assessment procedure)
Here you will get a image or chart

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

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

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"

Is in-country testing legally required?
Here you will get related hyperlink(s)

Source for standards for conformity assessment
Here you will get related hyperlink(s)

Acceptance of foreign test reports
Here you will get textual information

Acceptance of foreign test reports
Here you will get related hyperlink(s)

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get a image or chart

e. g. product label

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

Warnings, symbols
Here you will get textual information

e. g. ANSI Z 535.4


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Official Language
Standard Institute
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