Overview
On March 4th, 2022, the Japanese Ministry of Health, Labor and Welfare issued a summary of the Q&A related to the New QMS Ordinance. The Japanese QMS Ordinance has been revised to meet the ISO13485:2016 requirements, with a grace period given to related stakeholders until March 26th, 2024. This Q&A provides valuable insights for stakeholders to navigate the necessary actions during the grace period.
Key Q&A Items
In this article, Qualtech summarizes and introduces some of the Q&A items that are particularly significant for manufacturers and marketing authorization holders (MAH). Kindly note that the numbering used below is based on the MHLW's official release document, linked in the reference section at the end of the article.
Q2. What happens to the validity period of the QMS certificate that shows conformity with the old QMS Ordinance during the grace period?
A2. There are no changes made to the 5 years validity period, meaning that this QMS certificate remains valid until its expiration date.
Q3. What if the grace period ends earlier than the expiration date of the QMS certificate conforming with the old QMS ordinance?
A3. There won't be any necessary actions when the grace period ends. Please renew the QMS certificate as it approaches expiration to conform to the new QMS ordinance. However, related manufacturing authorization holders must ensure compliance with the new QMS ordinance during the grace period.
Q4. Can the QMS certificate still be used to omit QMS inspection of the same product category after the grace period ends, if the certificate is still valid?
A4. Yes.
References
Official Release Document - https://www.mhlw.go.jp/hourei/doc/tsuchi/T220308I0020.pdf
Type Approval impacted: MEDICAL
Date published: 04/27/22