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T V Rheinland Group Global Regulations An Overview Mr. Enrico Ruhle Managing Director T V Rheinland India Private Li

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T V Rheinland Group Global Regulations An Overview Mr. Enrico Ruhle Managing Director T V Rheinland India Private Li

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    2. Content

    5. Introduction - TV Rheinland Group

    6. Offices World Wide

    7. Offices Worldwide - Asia

    8. Offices Worldwide - Europe

    9. Offices Worldwide - Americas

    10. Industrial Service TV Rheinland industrial services ensure maximum safety, optimal functioning and the smooth operation of plants, equipment, constructions and systems. We offer all necessary accreditations.

    11. Products

    12. Education & Consulting

    13. TV Rheinland STAR *

    14. Opportunities For Exporters

    16. Electronics & Software Export 2007 - 2008 Opportunities For Exporters

    17. Key Statistics Top Ten Trading Partners for India

    18. Agencies India / Europe

    19. Agencies involved: India BIS Bureau of Indian Standards STQC Standardization Testing & Quality Certification WPC Wireless Planning & Coordination Wing TEC Telecommunication Engineering Centre IBR Indian Boiler Regulation CDSCO Central Drug Standard Control Organization (IMRDA)

    21. Recent Limelight incidents in India Six-day-old infant burnt alive in Delhi hospital March 12th, 2008 - 9:57 pm ICT by admin Five infants killed in Punjab hospital fire (Lead) January 31st, 2009 - 1:44 pm ICT by IANS Four-month-old dies in incubator in Allahabad hospital Lucknow May 3

    22. NEW DELHI: India is working on new regulations for toy imports which would make it mandatory for all countries wanting to sell toys to India to meet prescribed quality norms. The move follows Chinas complaint that the quality restrictions imposed by India on Chinese toys violated the World Trade Organization (WTO) rule of treating all member countries alike. Source: www.indiatimes.com

    23. Regulations in India vs Europe The Government of India is proposing to set-up the Indian Medical Devices Regulatory Authority (IMDRA). The IMDRA is expected to formulate appropriate guidelines to be a national certifying and regulatory agency in India for medical equipment and devices. Bureau of Indian Standard (BIS) has a Limited Scope. BIS standards refers to very old regulations like IS 6567:1972.

    24. HOW DIFFICULT IS CE MARKING?

    25. HOW DIFFICULT IS CE MARKING? It is not !! In fact easier than ISI mark !! The requirements of CE marking on based on international standards which are made considering all member countries inputs including India (IEC standards). Requirements laid down are bare minimum requirements. Majorly concentrating on EHSR ( Environmental Health and Safety Requirements). Manufacturer can show compliance and self Declare.

    26. HOW DIFFICULT IS CE MARKING? ISI mark not only confirms to product safety but also considers performance requirements. Certification can be done only by BIS. Annual follow-ups are mandatory. Note: Supply voltage system in Europe and India is same!! Also the environmental conditions in India are more stringent than Europe.

    29. Product Off Market Due To Non - Compliance

    30. Compliance & Accreditation

    32. Other important certifications for Exporters

    33. Changes in Compliance Requirements Todays compliance requirements have a wide scope, but are still limited to materials and substances and can therefore easily be assessed/measured (given that the appropriate tools are available) Tomorrows requirements will be multidimensional, evolving around various aspects that are being formulated by societys expectations Future compliance requirements might not be limited to clearly formulated laws and regulations, but might also include norms that are being communicated by the civil society through other channels. Above testing, auditing services might be required. With societies being more and more globally interconnected, information exchange ensures that consumers can more easily and quickly evaluate companies and express their expectations towards them (leading to an increased pressure on global businesses from consumers & media) Todays compliance requirements have a wide scope, but are still limited to materials and substances and can therefore easily be assessed/measured (given that the appropriate tools are available) Tomorrows requirements will be multidimensional, evolving around various aspects that are being formulated by societys expectations Future compliance requirements might not be limited to clearly formulated laws and regulations, but might also include norms that are being communicated by the civil society through other channels. Above testing, auditing services might be required. With societies being more and more globally interconnected, information exchange ensures that consumers can more easily and quickly evaluate companies and express their expectations towards them (leading to an increased pressure on global businesses from consumers & media)

    34. A Possible Scenario for Future Compliance Requirements Various countries & cultures all have different sets of values, leading to various standards Environmental consciousness among societies is growing Growing body of environmental laws at national & international levels Information is shared globally, consumers demand more transparency regarding business processes => TOMORROWs COMPLIANCE REQUIREMENTS WILL BE MULTI-DIMENSIONAL Present level: Environmental regulations, affecting most of the stakeholders in the supply chain Future level: regulations covering aspects located even before the producer (e.g. various issues of corporate social responsibility) The challenge for globally operating companies in order to remain competitive is to be compliant with societys expectations & values before they translate into laws and regulations (e.g. test report standards, compatibility with other products, etc.) Environmental impact (e.g. of raw materials acquisition soil erosion, etc.) Monitoring (of sales channels & market access conditions; fair trade)by authorities, NGOs, etc. Political, social, etc. conditions of the producing country (ethics of sales structures)Various countries & cultures all have different sets of values, leading to various standards Environmental consciousness among societies is growing Growing body of environmental laws at national & international levels Information is shared globally, consumers demand more transparency regarding business processes => TOMORROWs COMPLIANCE REQUIREMENTS WILL BE MULTI-DIMENSIONAL Present level: Environmental regulations, affecting most of the stakeholders in the supply chain Future level: regulations covering aspects located even before the producer (e.g. various issues of corporate social responsibility) The challenge for globally operating companies in order to remain competitive is to be compliant with societys expectations & values before they translate into laws and regulations (e.g. test report standards, compatibility with other products, etc.) Environmental impact (e.g. of raw materials acquisition soil erosion, etc.) Monitoring (of sales channels & market access conditions; fair trade)by authorities, NGOs, etc. Political, social, etc. conditions of the producing country (ethics of sales structures)

    36. Thank you

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