Introduction to GMA Global Market Access Presented by Theresa Glenna 2015.2.10 11/02/2015 Slide 1
Agenda 1 Intro to and GMA 2 Where to Start 3 Next Steps and Planning 4 Leveraging Existing Reports 5 Adding Wireless Technology 6 Regulatory Changes and Updates 11/02/2015 Slide 2
Our Heritage: 146 Years of Business Success 1866 1910 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 First vehicle periodic technical inspection (PTI) 1926 Introduction of the TÜV mark / stamp in Germany 1958 Development of a Bavaria-wide network of vehicle inspection centers in the late 1950s 1990s Conglomeration of TÜVs from the southern part of Germany to form and the expansion of business operations into Asia 2006 Expansion of services in ASEAN by acquiring Singapore-based PSB Group 2009 Launch of Turkey-wide vehicle inspection by TÜVTURK Today continues to pursue a strategy of internationalisation and growth 14-01-22 Corporate Presentation AG Slide 3
Choose Certainty. Add Value. Today, stays true to its founding principle of protecting people, environment and property against the adverse effects of technology. 14-01-22 Corporate Presentation AG Slide 4
in numbers: Growing from strength to strength 1 One-stop technical solution provider 150 Years of experience 800 Locations worldwide 1,900 20,200 Million Euro in sales revenue 2013 Employees worldwide Note: Figures have been rounded off. 14-05-12 Corporate presentation TÜV SÜD
Technical Expertise & Broad Industry Knowledge Testing & product certification Inspection Auditing & system certification Knowledge services Training Chemical, physical, mechanical, electrical and environmental testing and product certification. Product, system, building, plant and infrastructure inspection. Audits system certification in a variety of fields including quality, safety, energy, social compliance and environment. Safety, quality, risk, environmental protection and regulatory advisory. Training in work safety, technical skills, management systems and executive programs. 14-01-22 Corporate Presentation AG Slide 6
Global Expertise. Local Experience. Global Headquarters: Munich, Germany Legend: Countries with offices Regional headquarters GERMANY Euro 1,130 mio 10,200 staff INTERNATIONAL Euro 690 mio 8,600 staff 14-01-22 Corporate Presentation AG Slide 8
America Locations
Intro to GMA Local Team 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 Global Team Headed By Marco Schirr, VP Technical Governance & Regulatory Compliance Global Network Global Network TÜV GMA Global Team TÜV Offices Local Accreditations MRAs with Certification bodies and test labs
Typical GMA Process 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 11/02/2015 Corporate Presentation Slide 11
Sample of Countries Serviced by 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
Agenda 1 Intro to and GMA 2 Where to Start 3 Next Steps and Planning 4 Leveraging Existing Reports 5 Adding Wireless Technology 6 Regulatory Changes and Updates 11/02/2015 Slide 13
Do I Need GMA? Mandatory Required to sell or import in specific country(ies) Market Driven Gain a competitive edge, ability to sell in global market Customer Driven End customer has need or desire to sell globally 11/02/2015 Slide 14
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
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. Domestic Use (8516.60.xxxx) Industrial Use (8514.10.xxxx) Electric Oven
Design Phase: Questions to Ask 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: End Use Application Case Study Power Supply Medical Office
Design Phase: End Use Application Case Study Fan Household Industrial
Design Phase: Factors to Consider Component selection Global Market = components having global/international approvals Case study (power supply approvals- see next slide)
Design Phase: Factors to Consider
Design Phase: Factors to Consider What are your technologies? Plans to integrate wireless? Case study (adding wireless= adding another layer of approvals) *Non-Wireless *Wireless China: CCC Brazil: INMETRO Taiwan: BSMI Mexico: NOM China: CCC + SRRC Brazil: INMETRO + ANATEL Taiwan: BSMI + NCC Mexico: NOM + IFETEL *List is not comprehensive
Agenda 1 Intro to and GMA 2 Where to Start 3 Next Steps and Planning 4 Leveraging Existing Reports 5 Adding Wireless Technology 6 Regulatory Changes and Updates 11/02/2015 Slide 23
Next Steps Preparing for Testing Testing for Multiple Markets Australia, Japan, Korea, Taiwan (EMC) National Deviations in CB Report Consider country voltage and frequency when doing testing Documentation must match! (Reports, manuals, labels, etc.) Model numbers X and Y variables Families Regulatory Model Number (Case Study) Company name (business license) OEMs and Brand Names
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
CB Scheme Overview Member Countries Argentina Denmark Kazakhstan Romania Australia Finland Kenya Russia Austria France Korea Saudi Arabia Bahrain Germany Libya Serbia Belarus Greece Malaysia Singapore Belgium Hungary Mexico Slovakia Brazil India Netherlands Slovenia Bulgaria Indonesia New Zealand South Africa Canada Iran Nigeria Spain UAE China Ireland Norway Sweden UK Colombia Israel Pakistan Switzerland USA Croatia Italy Poland Thailand Ukraine Czech Republic Japan Portugal Turkey Vietnam
Next Steps Preparing for Testing Regulatory Model Number Can reduce the number of approvals required Can simplify your regulatory process Example- Model: 1234-xxx, where x= Color Software changes Customer specific info Accessories included in box Other non-hardware changes Regulatory Model: 1234 Model 1234-xxx is considered marketing model number and not shown on any compliance documents.
Documentation Important Notes Product Label Trademark/Brand Regulatory Model Number Regulatory marks Country of origin Date of manufacture Warning statements/translations Manual and Warnings May be an abbreviated manual. Must include warnings and basic set-up instructions Translation may be required in the official language of the country Model Families Define differences (supporting documentation) Family classification varies by country
Documentation Important Notes Reports Latest Standard National Deviations 3 Years Old (or less) Technical Documentation Critical Components List and Component Certificates Schematics, Board Layouts, etc. Test Set-Up Instructions Simple Easy to Follow Illustrations
Local Representatives Registration / licensing can provide (for a fee) Actual importer/distributor Responsibility varies
Factory Inspections is authorized combines inspections Certification body must do inspection Lengthy wait times
Agenda 1 Intro to and GMA 2 Where to Start 3 Next Steps and Planning 4 Leveraging Existing Reports 5 Adding Wireless Technology 6 Regulatory Changes and Updates 11/02/2015 Slide 32
What If I Have Already Started Testing? Basic European Reports for CE Marking (Safety & EMC) Add National Deviations Add EMC Testing (Korea, Taiwan etc) Add Factory Inspection Add Pre- Shipment Inspection and CoC Add Local Rep Add In Country Testing
Building on Your Reports: Using Basic EU Reports- CE Basic European Reports for CE Marking Safety CE Report EMC reports for EU Countries: European Union Members Add Factory Inspection Russia/Belarus/Kazakhstan Argentina Ukraine Moldova Add Pre-shipment Inspection Saudi Arabia Kuwait Note: Example for illustration only. Actual product requirements may differ. Not all countries offered are listed.
Building on Your Reports International Reports CB Report and Certificate with US/CAN/EU deviations EMC reports for EU/US/CAN Note: Example for illustration only. Not all countries offered are listed. Example builds on previous slides Countries: European Union Members US Canada Israel Kenya Nigeria S. Africa (EMC) Australia/New Zealand (EMC) Singapore Serbia
Building on Your Reports: CB and EMC Reports with Deviations International Reports - Add National Deviations for all countries CB Report and Certificate with all deviations EMC reports for EU/US/CAN, Australia/New Zealand, Japan, Korea, Taiwan Countries: Taiwan Korea (EMC) Australia New Zealand Add Factory Inspections: Argentina Korea (Safety) South Africa (Safety LoA) Uzbekistan Add In-Country Testing: China India Japan (PSE-Diamond) Mexico Note: Example for illustration only. Not all countries offered are listed. Example builds on previous slides
Agenda 1 Intro to and GMA 2 Where to Start 3 Next Steps and Planning 4 Leveraging Existing Reports 5 Adding Wireless Technology 6 Regulatory Changes and Updates 11/02/2015 Slide 37
Wireless Product Approvals Countries Recognizing FCC El Salvador, Guatemala, Panama, Anguilla, American Samoa, Cayman Islands, Guam, Palau, Puerto Rico, US Virgin Islands Approvals Using Wireless Reports for US/CAN 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 In-Country Testing Required Mexico (2.4GHz, 5GHz, 900MHz only) Brazil Argentina Some others for certain devices (ex: cellular) Note: Example for illustration only. Actual requirements may vary. Not all countries offered are listed. Example builds on previous slides
Wireless Product Approvals Countries recognizing EU DoC (CE Marking) Afghanistan, Andorra, Georgia, Gibraltar, Maldives, Monaco, San Marino, Sao Tome and Principe, Seychelles Approvals using EU R&TTE Directive reports 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, Sample Required for Review or Testing : Kenya, Jordan, Tunisia Ukraine UAE (new!) Exceptions Ex: Cellular Note: Example for illustration only. Actual requirements may vary. Not all countries offered are listed. Example builds on previous slides
Wireless Product Approvals Approvals Using Either FCC or R&TTE Reports Hong Kong, Singapore Cambodia, India, Gambia, Ghana, Lesotho, Namibia, Nepal, Papua New Guinea, Philippines, Thailand, Uruguay Special Reports: Australia, New Zealand Testing : Kenya, Jordan, Tunisia Ukraine UAE (new sample requirement) Indonesia Malaysia, Pakistan (minimal) South Korea Exceptions Ex: Cellular Note: Example for illustration only. Actual requirements may vary. Not all countries offered are listed. Example builds on previous slides
Other Considerations: Wireless Devices Label Requirements Allowed Frequency Bands Licensed Band Products Modular vs. End Product Approvals Multiple Authorities
Agenda 1 Intro to and GMA 2 Where to Start 3 Next Steps and Planning 4 Leveraging Existing Reports 5 Adding Wireless Technology 6 Regulatory Changes and Updates 11/02/2015 Slide 42
Regulatory Changes and Updates China 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 Korea: Safety Current voltage 50V 1000V changed to anything under 1000 requiring certification. Effective July 31, 2014 Taiwan 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.
Regulatory Changes and Updates Japan 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. Philippines January 2015: Mandatory safety requirements for CRT and LCD TVs (up to 45 inches and up to 250VAC) and CD/DVD players (110-250VAC). GCC (Gulf Cooperation Counsel) 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
Regulatory Changes and Updates India Potential accreditation of test labs outside of India Currently, s lab in India is able to facilitate this process. Phase 2 expansion of goods, Batteries effective August 2015, all others effective May 2015
Regulatory Changes and Updates Brazil: Telecom 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: Safety INMETRO approval will become mandatory for IT Equipment starting Q4 2015. Announcing TUV SUD Brazil Certification body for INMETRO. Uruguay: Telecom 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.
Regulatory Changes and Updates Thailand: Safety and EMC New Regulations in force as of December 14, 2014 for Uninterruptible Power Supplies (UPS) Egypt: Wireless 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 Vietnam: Telecom Ministry of Information and Communications (MIC) approved an update EMC standard QCVN18:2014BTTT, effective on January 1, 2015. Congo: Wireless Samples are now required as of January 1, 2015. Possible to apply for a waiver.
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