Regulatory Affairs in Japan

We can help you with the following aspects regarding the regulatory and QMS requirements for the Japanese Market:

• Product classification assessment
• Regulatory assessment for new and/or changed product
• Compilation or review of registration dossier.
• Interpretation of applicable technical assessment standards (JIS Standards)
• Evaluation and development of Quality Management System in accordance with Japanese QMS requirements according to the "MHLW Ministerial Ordinance No 169, 2004 "
• Selection of a Japanese third party certification body for your specific product.
• Selection and evaluation of designated MAH.

We have started an evaluation of available Registered Certification Bodies under PAL.