Aug 23, 2016

Japan’s Ministry of Health, Labour and Welfare (MHLW) has published an administrative notice on how some of 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 notice focuses 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.)

There are three key points manufacturers should bear in mind regarding the notice:

  • First, companies registered in Japan that implement or transition to ISO 13485:2016 are now considered to be compliant with Chapter 2 of Ordinance No. 169. However, registrants should still expect to undergo Japanese quality system auditing and surveillance.
  • Second, the MHLW's allowance for firms compliant with ISO 13485:2016 to also be considered compliant with Chapter 2 of the Ordinance is temporary. Japanese regulators have not indicated yet whether and when they will modify Chapter 2 of Ordinance No. 169 to reflect ISO 13485:2016.
  • Third, registrants do not have to maintain ISO 13485:2003 certification in order to stay in compliance with Japan's quality system regulations provided that they properly transition to and implement ISO 13485:2016.

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 and Ordinance No. 169 will be posted as we learn them.


  • Stewart Eisenhart