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

By Stewart Eisenhart, Emergo Group

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

According to an analysis of the MHLW notice by Emergo’s Tokyo office, the MHLW has established a three-year transition period for moving from the old ISO 13485:2003 standard to ISO 13485:2016. The notice focuses particularly on the relationship between the updated ISO standard and Chapter 2 of the MHLW Ministerial Ordinance No. 169 covering medical device quality system compliance in Japan.

(Ordinance No. 169 entails some quality system requirements specific to the Japanese market. To learn more about Ordinance No. 169 compliance, download our whitepaper.)

Specific links Chapter Two of Ordinance No. 169 and clauses of ISO 13485:2016 mentioned by the MHLW in the notice include:

• Target manufacturers: Manufactures applying for new or partial-change Pre-Market Approvals or Pre-Market Certifications in Japan
• Target products: Medical devices and IVDs registered for sale in Japan
• Before change and after change: After change, manufacturers that perform product and quality management according to ISO 13485:2016 are considered compliant by MHLW with Chapter 2 of Ordinance No. 169; before change, two MHLW notifications regulated the alignment of Chapter 2 of the Ordinance and ISO 13485:2003, but those notifications are not being revised because ISO 13485:2016 has not changed significantly from ISO 13485:2003 in terms of the basic elements of configuration for quality management

Any further developments on the MHLW’s efforts to align ISO 13485:2016 andOrdinance No. 169 will be posted as we learn them.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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