Japanese MHLW Recognizes UL Affiliate for Medical Certification

Underwriters Laboratories (UL) announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has recognized its affiliate in Japan, 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 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.