Japan MHLW Ordinance 169 and Medical Device and IVD QMS Requirements

Accessing Japan’s medical device market involves more than just meeting FDA or CE requirements. Companies must navigate additional regulatory steps to sell their products in Japan. Emergo by UL expert Hiroshi Morishita breaks down the Japanese QMS process and highlights the key differences between Japan’s MO#169 and the global ISO 13485 standard.

He also covers the critical role contract manufacturers play, explaining their need to comply with MO#169 and undergo separate audits to meet Japan’s regulatory demands. This comprehensive overview provides manufacturers from various regions with a look at the necessary QMS auditing, certification and renewal processes to successfully enter the Japanese market.