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Japanese Ministry of Health, Labor and Welfare Recognizes Underwriters Laboratories Affiliate for Medical Certification

April 19, 2005 - Underwriters Laboratories Inc. (UL) announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has recognized its affiliate in Japan, Apex Co., Ltd. (UL Apex), as a third-party Certification Body for active and implantable medical devices under the revised Pharmaceutical Affairs Law (PAL) of 2002.

UL Apex is one of a small number of respected third parties that MHLW has accredited to conduct quality systems assessments and review technical documentation submissions for class II medical devices within the scope of third-party evaluation under the revised PAL.

UL Apex is also a National Certification Body (NCB) in the CB Scheme of the International Electrotechnical Commission System for Conformity Testing to Standards for Safety of Electrical Equipment (IECEE). UL Apex is the only organization in Japan that offers both CB certifications and UL Certifications for Medical Devices in compliance with IEC and UL Standards.

"With this new accreditation, UL can provide its clients with greater flexibility and more conformity assessment service options," said Steve McRoberts, UL's principal engineer for Medical Regulatory & Proprietary Compliance. "Offering customers ready local access to a network that spans the globe, UL is now better positioned to provide medical customers with access to this significant Asian market."

UL will now begin offering certification services to help medical device manufacturers with new products gain access to the Japanese market via registration to ISO 13485:2003, along with any additional local requirements that might apply. UL Apex will also assist manufacturers with existing products renew authorizations under the revised PAL and develop a compliance plan for their Japanese representatives and distributors.

With this accreditation, Medical Device manufacturers can take advantage of UL's multiple regulatory services. A single integrated UL audit can now serve to address multiple global regulatory requirements, including PAL (Japan), CMDCAS (Canada), CE (Europe), INMETRO (Brazil) and ISO 13485:2003 Registration.

"UL's Total Market Access Solution allows manufacturers to achieve greater efficiency in complying with global regulatory requirements," said McRoberts. "Additionally, it also offers manufacturers the ability to select a local service provider to conduct an audit and interact in the local language and time zone, potentially reducing time to market for Medical Devices."

For more information on UL Apex's new accreditation, please contact principal engineer Steve McRoberts by email at Steve.A.Mcroberts@uk.ul.com.

Underwriters Laboratories Inc. (UL) is an independent, not-for-profit product safety certification organization that has been testing products for more than 110 years. UL tests more than 19,000 types of products annually and more than 19 billion UL Marks appear on products each year. Worldwide, UL's family of companies and its network of service providers include 58 laboratories, and testing and certification facilities.

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