From ISO and IEC to DIN and VDE - conformity is still a local issue!

More international standards for global product conformity, please.



→ A FIRST STEP WITH MRAS
→ STEP BY STEP FOR MORE SAFETY
→ EXAMPLE FROM PRACTICE
→ REGULATORY ESSENTIALS & ONLINE FINDER

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Each region describes its local market access requirements for products. Conformity assessment procedures and the available technical standards can be as diverse as the world's cultures.

Many product compliance managers are then faced with the challenge of researching the specific requirements for their products in the respective countries. In doing so, it is very important to develop cost-efficient solutions for achieving local conformity.

In this context, the question often arises as to whether or not a redesign is necessary in order to obtain approval in the respective export country. If this is the case, the next step is to explain to the company what specific measures may need to be taken to ensure the required approval.

The complex analysis of the requirements and their potential impact on product design has led to an increasing desire for ways to harmonize (or standardize) conformity assessment procedures in order to ensure the competitiveness of global products.

MANAGING PRODUCT COMPLIANCE MORE SECURELY WORLDWIDE


A FIRST STEP IN THE RIGHT DIRECTION - Mutual Recognition Agreements (MRAs)

An effective instrument on the way to an optimized approval strategy is to look at the so-called MRAs.

MRAs are bilateral agreements on the recognition and harmonization of different national approaches. MRAs can include the recognition of different school qualifications, but can also - as in our case - describe the recognition of different conformity assessment procedures.

The main aim of these MRAs is to enable partner countries to test and, if necessary, certify products in accordance with the rules and regulations of the other country on their own territory.

Thanks to an existing MRA, Australia, for example, recognizes many technical standards from European Standardization Organizations (ESO), e.g. ETSI.


List of countries that have a recognition agreement with the EU:

Australia

Switzerland

Canada

USA

Japan

Israel

New Zealand

Source European Union, as at 16.12.2024

STEP BY STEP TO MORE SECURITY

Being non-compliant can lead to significant fines, legal consequences and even exclusion from certain markets. By staying on top of all requirements, companies can ensure that they are compliant with all legal regulations and thus minimize potential financial and legal risks.

As a company, it is not only important to comply with legal regulations, but also to act ethically and responsibly. Knowing and complying with all requirements in the target markets shows that the company takes its social responsibility seriously and is committed to the well-being of the community, its employees and customers. Below is a step-by-step guide on how to achieve product compliance on the international stage:

Set up target regions
A list of countries must be drawn up for which it is necessary to research the requirements for market access.
 

Set starting point
Often an existing product is already compliant with a region, e.g. EU and/or USA.

 

Assessment of the G20 countries
It makes sense to extend the requirements analysis to other G20 countries and then to look at other countries and regions.

 

Develop a compliance strategy
Based on this information, a comprehensive compliance strategy needs to be developed. This includes identifying the necessary certificates, tests and documentation as well as defining schedules and responsibilities.
 


Internal training
This is the only way to ensure that the internal team is informed about the specific compliance requirements in the various countries and can act accordingly.

 

Monitoring and adaptation
Global regulations can change, so continuous monitoring and adaptation of the compliance strategy is crucial to ensure that products are compliant worldwide.

 

Example from practice

Dipl.-Ing. (FH) Anette Dunkel-Reinboth
Standards & Product Compliance Consultant



"When asked about sales markets, sales and product management often proclaim 'global' without realizing what this means in concrete terms.

Because only those who know the legal and normative requirements of the respective markets and applying them early on in the individual phases of the product development process can reduce possible risks that may arise when providing non-compliant products on global markets."


 

Frequently asked questions: Do I need a representative in the country of export? Does the exporting country have its own certification marks, and if so, where do they have to be affixed? Is the CE mark recognized in the country of export?

Expert tip: It is advisable to start the certification process in good time, as this can take longer than expected, depending on the country and product. This ensures that all the necessary certificates and approvals are available when the first products are to be exported.

Your challenges

Do you lack up-to-date information on the regulatory requirements of your international target markets?

Do you have not enough time and human resources to acquire this important knowledge?

Are you really able to assess whether the information you have researched comes from official sources and is up to date or not?

YOUR SOLUTION


REGULATORY ESSENTIALS

Modular information packages with essential information for compliant products in your target markets, incl:

  • An analysis of the regulatory requirements
  • Identification of the responsibilities of the relevant economic operators
  • Essential information on market access conditions
  • A list of labeling and documentation obligations
  • The "Route to Compliance" guide

Accessible online at any time on the ROGER WILLCO product compliance portal.
 

Your advantages

Immense time saving

Valuable know-how development

Current and correct information

Know what to do!

Combine subject areas and target markets of your products and know which Regulatory ESSENTIALS will help you!



DO YOU HAVE ANY QUESTIONS?

Our Regulatory ESSENTIALS team will be happy to help you:

Phone: +49 30 3229027-50
Email: essentials@globalnorm.de


 

REGULATORY ESSENTIALS
ACHIEVING COMPLIANT PRODUCTS MORE EASILY AND QUICKLY

 

Over 18 subject areas

 

Accessible online

 

More than 29 countries and economic areas

 

Regularly updated

 

 

More about the Regulatory ESSENTIALS

Benefit from MORE THAN 300 INFORMATION PACKAGES


Combine the legal areas and target markets relevant to you and create a knowledge database for your globally compliant product portfolio!

Subject areas:

 

Electromagnetic
Compatibility


Hazardous substances (RoHS)
 


Food contact
materials


Ecodesign & energy consumption

General chemical requirements (REACH)


Explosion protection (ATEX)


In Vitro Diagnostics


Machine safety/protection


X-ray radiation

Cybersecurity


Fluid systems and components


Critical infrastructure


Medical devices

Electrical safety


Radio equipment


Laser requirements


Metrology and metrology

Countries and economic areas:

EGYPT

China

HONGKONG

Canada

MALAYSIA

Switzerland

Thailand

UNITED ARAB EMIRATES

Australia

Eurasian economic area

India

Kazakhstan

MEXICO

Singapore

Turkey

UNITED KINGDOM

Brazil

European Economic Area

ISRAEL

Qatar

New Zealand

South Africa

UGANDA

CHILE

Gulf Cooperation Council

Japan

SOUTH KOREA

Saudi Arabia

TAIWAN

USA

Accessible online from anywhere:

You can conveniently read the Regulatory ESSENTIALS information online in the ROGER WILLCO product compliance portal.

  • Information compiled by experts on the market approval requirements in your target markets (in English)
     
  • Essential knowledge on requirements in the areas of electrical safety, radio, electromagnetic compatibility (EMC), hazardous substances (RoHS), explosion protection (ATEX), machine safety, etc.
     
  • Detailed information on the products covered and the approval procedures in accordance with the applicable legislation
     
  • Direct links to the applicable legislation and, where applicable, official interpretation aids
     
  • Helpful tips from our experts on understanding any associated requirements and more

 

 

Combine the subject areas and target markets relevant to your products in our online finder and get an overview of the appropriate Regulatory ESSENTIALS!

MAKE AN INQUIRY

REGULATORY ESSENTIAL ONLINE FINDER & CONSULTING

Do you want to find out specifically which subject areas and target markets you can use Regulatory ESSENTIALS for?
You can obtain non-binding advice online here in just 3 simple steps and then send us an inquiry:
 

Which topics are relevant for your company's products?

Which statements apply to your product?

Which target markets are relevant for the distribution of your products?

Your personal data will be processed by GLOBALNORM.
You can find further information in our privacy policy.

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THE EXPERTS BEHIND THE REGULATORY ESSENTIALS

All information is compiled by a team of experienced product and material compliance experts. It contains only relevant, up-to-date and verified information in English and is checked and updated at regular intervals.

Dipl.-Ing. (FH)
Michael Loerzer

Regulatory Affairs Specialist

B.A.
Linda Kritzler
Material & Environmental Compliance Consultant

Fully qualified lawyer
Inken Green
Product & Material Compliance Expert

B. Eng.
Benjamin Kerger

Product Compliance Expert (EMC, radio, safety)

Dipl.-Ing. (FH)
Torsten Sahm

Product Compliance Expert (EMC, radio, automotive)

Dipl.-Ing. (FH)
Anette Dunkel-Reinboth

Regulatory Analyst

 

Glossary

 

EMC

Electromagnetic compatibility (EMC) describes the ability of a technical device not to emit any unwanted electrical or electromagnetic interference to other devices or to be disturbed by other devices itself.

ISO

ISO stands for "International Organization for Standardization". It develops international standards for all areas outside of electrical engineering and electronics, for which the International Electrotechnical Commission is responsible, and outside of telecommunications, for which the International Telecommunication Union is responsible. These three organizations, known in close cooperation as the World Standards Cooperation, jointly define standards.

 

 

IEC

IEC stands for "International Electrotechnical Commission", an organization with an international scope that develops standards for electrical engineering and electronics and is headquartered in Geneva. Some of these standards are developed in cooperation with the International Organization for Standardization (ISO). Together with the ITU, the ISO and IEC form the World Standards Cooperation.

MRA

A Mutual Recognition Agreement (MRA) is an agreement between two or more countries or regulatory authorities that aims to enable the mutual recognition of examination procedures, certifications or regulatory standards.

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