Japan market access

Japan boasts the world's longest average lifespan, and its health maintenance and health-care markets are expanding rapidly. Some manufacturers mistakenly assume that products listed by a third party in their own countries, or those with the self-declared CE Marking for the European Union, can be sold in Japan without demonstrating compliance with Japanese standards or other technical requirements.

The Ministry of Health, Labour and Welfare (MHLW), Japan's equivalent of the U.S. Food and Drug Administration, mandates requirements for all medical devices entering the country. For electrical products, MHLW requires test data from a third-party testing organization, such as UL. This test data may be based on national requirements, which often can be IEC 60601-1. UL can test your product to the applicable electrical, mechanical, chemical and other safety standards and prepare the test report in Japanese, as well as in English.

The new Japan Pharmaceutical Affairs Law from the MHLW took effect on April 1, 2005. This law forms the basis for the regulation of medical devices in Japan. The regulations include medical devices and in-vitro diagnostic devices and employ a set of rules to classify each device into a risk-based classification. The higher risk class 3 and 4 devices must be evaluated by the PMDA (Pharmaceuticals and Medical Devices Agency -- prefectural agency of MHLW); however, most Class 2 devices, where a Japanese Industrial Standard (JIS) exists, can be evaluated by a third-party organization.

UL's third-party evaluation

• An assessment of the safety and effectiveness of the medical device.
• Assessment of the manufacturer's quality management system to ISO 13485 and particular deviations of the Japanese regulations. Most Class 1 devices can be self-declared; however, other Class 1 devices that are "specially designated" must be approved by the prefectural agency.

The UL advantage

UL has been recognized as one of only a few third-party assessment agencies under the new regulations. UL now offers 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 can also assist manufacturers with existing products renew authorizations under the revised PAL and develop a compliance plafn 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.

Additional resources

• Download UL's Article 'Regulatory Approvals of IVDs in Japan'- Reproduced with the kind permission of Global Regulatory Press from the Journal of Medical Device Regulation, 2009, 6(1), 24-33 (www.globalregulatorypress.com) (registration required)