Introduction to GMA - TÜV SÜD America Website - Choose · PDF file · 2015-02-11Introduction to GMA Global Market Access Presented by Theresa Glenna ... •National Deviations in

TÜV SÜD

Introduction to GMA

Global Market Access

Presented by Theresa Glenna

2015.2.10

11/02/2015 Slide 1 TÜV SÜD

TÜV SÜD

1 Intro to TÜV SÜD and GMA

2 Where to Start

3 Next Steps and Planning

Agenda

11/02/2015 Slide 2

4 Leveraging Existing Reports

5 Adding Wireless Technology

6 Regulatory Changes and Updates

TÜV SÜD

Our Heritage: 146 Years of Business Success

Establishment of a Mannheim-based steam boiler

inspection association by 21 operators and

owners of steam boilers, with the objective of

protecting man, the environment and property

against the risk emanating from a new and largely

unknown form of technology

1866

First vehicle periodic technical inspection (PTI) 1910

1958 Development of a Bavaria-wide network of vehicle

inspection centers in the late 1950s

1926 Introduction of the “TÜV mark / stamp” in Germany

1990s Conglomeration of TÜVs from the southern part of

Germany to form TÜV SÜD and the expansion of

business operations into Asia

TÜV SÜD continues to pursue a strategy of

internationalisation and growth

Today

2006 Expansion of services in ASEAN by acquiring

Singapore-based PSB Group

2009 Launch of Turkey-wide vehicle inspection by

TÜVTURK

TÜV SÜD AG Slide 3 14-01-22 Corporate Presentation

TÜV SÜD TÜV SÜD

Choose Certainty. Add Value.

Today, TÜV SÜD stays true to its founding

principle of protecting people,

environment and property against the

adverse effects of technology.


TÜV SÜD TÜV SÜD

TÜV SÜD in numbers: Growing from strength to strength

1 One-stop technical

solution provider

800 Locations worldwide

Employees worldwide 20,200

Million Euro in sales

revenue 2013

1,900

150 Years of experience

Note: Figures have been rounded off.

TÜV

SÜD

Slide 5

14-05-12 Corporate presentation

TÜV SÜD

Technical Expertise & Broad Industry Knowledge

Audits system

certification in a

variety of fields

including quality,

safety, energy,

social compliance

and environment.

Auditing &

system

certification

Product, system,

building, plant and

infrastructure

inspection.

Inspection

Safety, quality, risk,

environmental

protection and

regulatory advisory.

Knowledge

services

Chemical, physical,

mechanical,

electrical and

environmental

testing and product

certification.

Testing &

product

certification

Training in work

safety, technical

skills, management

systems and

executive programs.

Training


TÜV SÜD

Global Expertise. Local Experience.

Global Headquarters:

Munich, Germany

INTERNATIONAL

Euro 690 mio

8,600 staff

GERMANY

Euro 1,130 mio

10,200 staff

Legend:

Countries with TÜV SÜD offices

Regional headquarters


TÜV SÜD

TÜV SÜD America Locations

TÜV SÜD

Intro to GMA

Local Team

Global Team

Global Network

Local Team Kim Adams, Manager GMA USA

Theresa Glenna, Sales & Training Specialist, Senior Project Manager

Maja Bland, Project Manager

Lia Beliveau, Project Manager

Global Team Headed By Marco Schirr, VP Technical Governance & Regulatory Compliance

Global Network TÜV GMA Global Team

TÜV Offices

Local Accreditations

MRAs with Certification bodies and test labs

TÜV SÜD

Request Received

Quote Issued PO Issued

Forms Completed and Test Samples Sent (if required)

Documentation Gathered

Submittal Package Reviewed

Submittal Package

Submitted

Evaluation by Authority

Approval Granted

Typical GMA Process

11/02/2015 Corporate Presentation Slide 11

TÜV SÜD

Sample of Countries Serviced by TÜV SÜD GMA

Americas

• U.S.

• Canada

• Mexico

• Argentina

• Brazil

• All Central America

• All other South America

Europe

• European Union

• Nordic Countries

• Eastern Europe

• CIS Countries

Asia/Pacific

• China

• Taiwan

• Hong Kong

• Japan

• Korea

• Singapore

• Malaysia

• Thailand

• India

• Australia/New Zealand

Middle East and Africa

• Saudi Arabia

• Israel

• South Africa

• Many others

TÜV SÜD


2 Where to Start


Agenda

11/02/2015 Slide 13




TÜV SÜD

Do I Need GMA?

11/02/2015 Slide 14

• Required to sell or import in specific country(ies)

Mandatory

• Gain a competitive edge, ability to sell in global market

Market Driven

• End customer has need or desire to sell globally

Customer Driven

TÜV SÜD

Where do I start?

What certification(s) does my product need to be legally marketed in ____(name of country)__?

Who is the appropriate authority or regulator?

• Product characteristics

TÜV SÜD

Harmonized Tariff Code Determination is Key

An 8 to 10 digit number used to categorizes the appropriate product type and determine the amount of import tax to be paid.

• All countries use the same first 6 digits to describe the same products.

• Last 4 digits are country-specific.

Electric Oven

Domestic Use (8516.60.xxxx)

Industrial Use (8514.10.xxxx)

TÜV SÜD

What is your target market?

• 2-3 years

• 5 years

End use application?

Do you have a path?

• The Right Partnership?

GMA Compliance

Strategy

Design Phase: Questions to Ask

TÜV SÜD

Design Phase: End Use Application Case Study

• Medical

• Office

Power Supply

TÜV SÜD

Design Phase: End Use Application Case Study

• Household

• Industrial

Fan

http://www.freeimages.com/browse.phtml?f=download&id=1148065&redirect=photo

TÜV SÜD

Design Phase: Factors to Consider

• Global Market = components having global/international approvals

• Case study (power supply approvals- see next slide)

Component selection

TÜV SÜD


TÜV SÜD


• Plans to integrate wireless?

• Case study (adding wireless= adding another layer of approvals)

What are your technologies? • China: CCC

• Brazil: INMETRO

• Taiwan: BSMI

• Mexico: NOM

*Non-Wireless

• China: CCC + SRRC

• Brazil: INMETRO + ANATEL

• Taiwan: BSMI + NCC

• Mexico: NOM + IFETEL

*Wireless

*List is not comprehensive

TÜV SÜD


2 Where to Start


Agenda

11/02/2015 Slide 23




TÜV SÜD

Next Steps – Preparing for Testing

• Australia, Japan, Korea, Taiwan (EMC)

• National Deviations in CB Report

• Consider country voltage and frequency when doing testing

Testing for Multiple Markets

• Model numbers X and Y variables

• Families

• Regulatory Model Number (Case Study)

• Company name (business license)

• OEMs and Brand Names

Documentation must match! (Reports, manuals, labels, etc.)

TÜV SÜD

CB Scheme Overview

What is a CB Scheme? • An international agreement which allows

signatory countries to eliminate duplicate or repetitive testing* by accepting a single test report and certificate.

How does the CB Scheme work?

• Testing is done by an approved CB Test

Laboratory (CBTL) to internationally

harmonized standards

• National deviations are considered for member

countries

• Facilitates acceptance of test results* to obtain

specific national approvals.

CB Scheme Website – www.cbscheme.org/cbscheme/default.htm

*Some countries verify or repeat testing based on national requirements

http://www.cbscheme.org/cbscheme/default.htm

TÜV SÜD

CB Scheme Overview

Argentina

Australia

Austria

Bahrain

Belarus

Belgium

Brazil

Bulgaria

Canada

China

Colombia

Croatia

Czech Republic

Member Countries

Denmark

Finland

France

Germany

Greece

Hungary

India

Indonesia

Iran

Ireland

Israel

Italy

Japan

Kazakhstan

Kenya

Korea

Libya

Malaysia

Mexico

Netherlands

New Zealand

Nigeria

Norway

Pakistan

Poland

Portugal

Romania

Russia

Saudi Arabia

Serbia

Singapore

Slovakia

Slovenia

South Africa

Spain

Sweden

Switzerland

Thailand

Turkey

UAE

UK

USA

Ukraine

Vietnam

TÜV SÜD

Next Steps – Preparing for Testing

Regulatory Model Number

• Can reduce the number of approvals required

• Can simplify your regulatory process

Regulatory Model: 1234

• Model 1234-xxx is considered marketing model number and not shown on any compliance documents.

Example- Model: 1234-xxx, where x=

• Color

• Software changes

• Customer specific info

• Accessories included in box

• Other non-hardware changes

TÜV SÜD

Documentation – Important Notes

• Trademark/Brand

• Regulatory Model Number

• Regulatory marks

• Country of origin

• Date of manufacture

• Warning statements/translations

Product Label

• May be an abbreviated manual. Must include warnings and basic set-up instructions

• Translation may be required in the official language of the country

Manual and Warnings

• Define differences (supporting documentation)

• Family classification varies by country

Model Families

TÜV SÜD

Documentation – Important Notes

• Latest Standard

• National Deviations

• 3 Years Old (or less)

Reports

• Critical Components List and Component Certificates

• Schematics, Board Layouts, etc.

Technical Documentation

• Simple

• Easy to Follow

• Illustrations

Test Set-Up Instructions

TÜV SÜD

Local Representatives

• Registration / licensing

• TÜV SÜD can provide (for a fee)

• Actual importer/distributor

• Responsibility varies

TÜV SÜD

Factory Inspections

• TÜV SÜD is authorized

• TÜV SÜD combines inspections

• Certification body must do inspection

• Lengthy wait times

TÜV SÜD


2 Where to Start


Agenda

11/02/2015 Slide 32




TÜV SÜD

What If I Have Already Started Testing?

Add EMC

Testing

(Korea,

Taiwan etc)

Add

Factory

Inspection

Add Local

Rep

Basic European

Reports for CE

Marking

(Safety & EMC)

Add

National

Deviations

Add

In Country

Testing

Add Pre-

Shipment

Inspection

and CoC

TÜV SÜD

Building on Your Reports: Using Basic EU Reports- CE

Note: Example for illustration only. Actual product requirements may differ. Not all countries offered are listed.

• Safety CE Report

• EMC reports for EU

Basic European Reports for CE Marking

• European Union Members

Countries:

• Russia/Belarus/Kazakhstan

• Argentina

• Ukraine

• Moldova

Add Factory Inspection

• Saudi Arabia

• Kuwait

Add Pre-shipment Inspection

TÜV SÜD

Building on Your Reports

Note: Example for illustration only. Not all countries offered are listed. Example builds on previous slides

• CB Report and Certificate with US/CAN/EU deviations

• EMC reports for EU/US/CAN

International Reports

• European Union Members

• US

• Canada

• Israel

• Kenya

• Nigeria

• S. Africa (EMC)

• Australia/New Zealand (EMC)

• Singapore

• Serbia

Countries:

TÜV SÜD

Building on Your Reports: CB and EMC Reports with Deviations

• CB Report and Certificate with all deviations

• EMC reports for EU/US/CAN, Australia/New Zealand, Japan, Korea, Taiwan

International Reports - Add National Deviations for all countries

• Taiwan

• Korea (EMC)

• Australia

• New Zealand

Countries:

• Argentina

• Korea (Safety)

• South Africa (Safety LoA)

• Uzbekistan

Add Factory Inspections:

• China

• India

• Japan (PSE-Diamond)

• Mexico

Add In-Country Testing:

Note: Example for illustration only. Not all countries offered are listed. Example builds on previous slides

TÜV SÜD


2 Where to Start


Agenda

11/02/2015 Slide 37




TÜV SÜD

Wireless Product Approvals

• El Salvador, Guatemala, Panama, Anguilla, American Samoa, Cayman Islands, Guam, Palau, Puerto Rico, US Virgin Islands

Countries Recognizing FCC

• Mexico (products other than 2.4GHz, 5GHz, and 900MHz)

• Aruba, Barbados, Belize, Bermuda, Bolivia, British Virgin Islands, Chile, Colombia, Costa Rica, Dominica, Dominican Republic, Ecuador, Guyana, Grenada, Honduras, Jamaica, Nicaragua, Paraguay, Peru, St. Lucia, Trinidad & Tobago, Venezuela

Approvals Using Wireless Reports for US/CAN

• Mexico (2.4GHz, 5GHz, 900MHz only)

• Brazil

• Argentina

• Some others for certain devices (ex: cellular)

In-Country Testing Required

Note: Example for illustration only. Actual requirements may vary. Not all countries offered are listed. Example builds on previous slides

TÜV SÜD


• Afghanistan, Andorra, Georgia, Gibraltar, Maldives, Monaco, San Marino, Sao Tome and Principe, Seychelles

Countries recognizing EU DoC (CE Marking)

• EU

• Russia

• Belarus

• Kazakhstan

• Albania, Bahrain, Croatia, Egypt, Jordan, Kuwait, Kenya, Lebanon, Macedonia, Montenegro, Morocco, Nigeria, Oman, Qatar, Saudi Arabia, Serbia, South Africa, Tanzania, Tunisia, Turkey, Uganda, Israel,

Approvals using EU R&TTE Directive reports

• Kenya, Jordan, Tunisia

• Ukraine

• UAE (new!)

Sample Required for Review or Testing :

• Ex: Cellular

Exceptions


TÜV SÜD

• Hong Kong, Singapore

• Cambodia, India, Gambia, Ghana, Lesotho, Namibia, Nepal, Papua New Guinea, Philippines, Thailand, Uruguay

Approvals Using Either FCC or R&TTE Reports

• Australia, New Zealand

Special Reports:

• Kenya, Jordan, Tunisia

• Ukraine

• UAE (new sample requirement)

• Indonesia

• Malaysia, Pakistan (minimal)

• South Korea

Testing :

• Ex: Cellular

Exceptions



TÜV SÜD

Other Considerations: Wireless Devices

Label Requirements

Allowed Frequency Bands

Licensed Band Products

Modular vs. End Product Approvals

Multiple Authorities

TÜV SÜD


2 Where to Start


Agenda

11/02/2015 Slide 42




TÜV SÜD

Regulatory Changes and Updates

• Authorizing additional non-governmental test labs within China.

• TÜV inspectors applying for authorization to perform CQC inspections.

• New products added to CCC Catalog effective Sept. 1, 2014. Certification mandatory to import product into China starting Sept. 1, 2015.

• Categories: Ballasts, Residual current protective devices, Circuit breakers, Wire and cable

China

• Current voltage 50V – 1000V changed to anything under 1000 requiring certification. Effective July 31, 2014

Korea: Safety

• As of Aug 27, 2014: BSMI Certificates include a reference to the power cord associated with the product.

• As of Sept 1, 2014 for new applications: Power cords must have BSMI approval regardless of whether or not they will be sold separately and will be identified at the time of application.

Taiwan

TÜV SÜD


• Just announced: New revision to Japanese Safety Act.

• All products must comply with the new revision starting Sept 1, 2015.

• Telecommunications Business Law (JATE) and Radio Law (TELEC) amended

• Effective September 1, 2014.

• Changes: Minimum size of mark, allowance for marking information on manual or packaging depending on size of device, and on the host of the device.

Japan

• January 2015: Mandatory safety requirements for CRT and LCD TVs (up to 45 inches and up to 250VAC) and CD/DVD players (110-250VAC).

Philippines

• Members: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, UAE

• Low Voltage Electrical Equipment and Appliances, Gulf Technical Regulation is approved and goes into force on July 1, 2016

• Compliance shown using CB Scheme Reports

GCC (Gulf Cooperation Counsel)

TÜV SÜD


• Potential accreditation of test labs outside of India

• Currently, TÜV SÜD’s lab in India is able to facilitate this process.

India

Phase 2 expansion of goods, Batteries effective August 2015, all others effective May 2015

TÜV SÜD


• New allocation of radio frequency bands 71-76 GHz and 81-86 GHz for use by telecommunications service in point-to-point applications in primary and non-exclusive basis.

Brazil: Telecom

• INMETRO approval will become mandatory for IT Equipment starting Q4 2015.

• Announcing TUV SUD Brazil Certification body for INMETRO.

Brazil: Safety

• WLAN band (5.470-5.725 GHz) is now closed for commercial products.

• Band must be disabled

• Government use only

• Existing products on the market can continue to operate.

Uruguay: Telecom

TÜV SÜD


• New Regulations in force as of December 14, 2014 for Uninterruptible Power Supplies (UPS)

Thailand: Safety and EMC

• WLAN devices operating in band 4 and 4+ of the 5GHz band may now operate indoors only up to 200 mW EIRP, on a license-free basis.

• The 5 GHz bands now permitted in Egypt are as follows:

• 5150 - 5350 MHz - <200mW (EIRP) for indoor operation, license-free.

• 5725 - 5850 MHz - <200mW (EIRP) for outdoor operation, license required

Egypt: Wireless

• Ministry of Information and Communications (MIC) approved an update EMC standard QCVN18:2014BTTT, effective on January 1, 2015.

Vietnam: Telecom

• Samples are now required as of January 1, 2015. Possible to apply for a waiver.

Congo: Wireless

TÜV SÜD

The TÜV SÜD Advantage

Global Network

Knowledge

Experience

Service

TÜV SÜD

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Introduction to GMA - TÜV SÜD America Website - Choose · PDF file · 2015-02-11Introduction to GMA Global Market Access Presented by Theresa Glenna ... •National Deviations in