Japanese MHLW Aligns ISO 13485:2016 with Its Own QMS Requirements

Japan’s Ministry of Health, Labour and Welfare (MHLW) has released an administrative notice on how the new ISO 13485:2016 quality system standard for medical devices will be integrated into the country’s specific QMS requirements.

The MHLW has established a three-year transition period for moving from the old ISO 13485:2003 standard to ISO 13485:2016.

This notice mainly affects manufacturers applying for new and partial changes of Pre-Market Approvals or Pre-Market Certifications in Japan; and products for sale in Japan. — Cynthia Jessup