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Asia On The Mark Issue 26 (Summer 2008)

News Bites

SafetyAtHome.com — Safety Source for Moms

 
   
UL just launched SafetyAtHome.com as the ultimate resource for facts, advice and tips to help all mothers keep their families safe. Indeed, this site does a lot more than safety. Apart from comprehensive safety tips and resources library, U.S. consumers can also join interactive events like “Just Look for UL” for getting a chance to win great prizes and other Safety-related events to be held throughout the country. Keri Russell, a new-mom artist, also joins UL to help spread safety messages and invites others to make UL’s safety mission a reality.

   
In the spotlight: MOU Signing cum Office Opening in Vietnam

Witnessed by Dr. Ngo Quy Viet, Director General of Directorate for Standards and Quality (STAMEQ), UL signed a Memorandum of Understanding (MOU) with Quatest 3, Vietnam, one of the leading conformity assessment organizations in Vietnam.

Under the MOU, UL and Quatest 3 will recognize each other’s test results or evaluations as basis for providing the certification required by a manufacturer according to the applicable standards. The cooperation covers conformity assessments of manufacturers’ products, components, materials and systems and the certification of products according to national and international standards.

Speaking at the signing ceremony of the MOU, at Ho Chi Minh City, Sajeev Jesudas, President (International) of Underwriters Laboratories said “this agreement will provide a boost to international trade by allowing both organizations to respond efficiently to Vietnamese manufacturers who intend to export their products to overseas markets and also for international manufacturers who intend to sell their products in the Vietnam market.”

UL also announced the opening of its Vietnam Representative Office in Ho Chi Minh. “Vietnam is a critical addition to our ASEAN footprint, and a focus area for future investments,” stated J. C. Sekar, Managing Director (ASEAN) for UL.

   
Summary Technical Documentation (STED) — promoting harmonization of regulatory documentation in Medical Device Industry

The Global Harmonization Task Force (GHTF) has developed the summary technical documentation (STED) in an effort to promote “harmonized” guidance for the contents of regulatory submissions of the documentation providing evidence of conformity of a medical device to the essential principles of safety and performance.

According to GHTF the objective of the STED guidance is to assist manufacturers and regulators by recommending the basis for a common format. This could ultimately enable medical device manufacturers to prepare documentation in a STED format and for that STED submission to be an acceptable foundation to provide multiple Regulatory Authorities or CAB (e.g. EU Notified Bodies) with the same body of documentary evidence that its medical device conforms to the essential principles. The goal of the Summary Technical Documentation should help eliminate differences in documentation requirements between jurisdictions, thus decreasing the cost of gaining regulatory compliance and allowing patients earlier access to new technologies and treatments.

The EU system has encouraged the adoption of the STED in Europe as it fits well with the European technical documentation requirements and further discussion on the use of the STED format is expected.

In Asia the Asian Harmonization Working Party (AHWP) is seeking views on the proposed Common Submission Dossier Template (CSDT) Guidance Document which is based on the GHTF STED.

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In this Issue
Standards Developer’s Drive for International Harmonization
Renewable Energy Expo in India
UL NEBS FASTRACK On-site Witness Test Accreditation
Protecting the Interest of Responsible Manufacturers
Risk Management in Safety Product Design and Development
Safety Standard Requirements for LED Lighting Products
Safety of High Tech Controls
UL Nanjing office strengthens FUS services for North China
UL University “Educating the people who make the world a safer place”
UL University
UL Standards
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