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 and the grace period given to related stakeholders is three years until March 26th, 2024. This Q&A greatly assists related stakeholders in understanding the necessary actions to be taken during the grace period.

In this article, Qualtech will summarize and introduce some of the Q&A items, which are particularly important to know for manufacturers as well as marketing authorization holders (MAH). Kindly note that the numbering used below is based on MHLW’s official release document, the link to which can be found 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/the validity period of the QMS certificate that received inspection and conformity with the old QMS ordinance is checked during the grace period?
A2. There are no changes made to the 5 years validity period. In turn meaning that this QMS certificate is valid until the expiration date.

Q3. What if the grace period ends earlier than the expiration date of the QMS certificate in Q2 conforming with the old QMS ordinance?
A3. There won’t be any necessary actions to take WHEN the grace period ends. Please renew the QMS certificate when it is about to expire and have it conformed with the new QMS ordinance. However related manufacturing authorization holders must check whether they as well as the related manufacturing sites are complied with the new QMS ordinance during the grace period.

Q4. Can the QMS certificate in Q2 be still used to omit QMS inspection of the same product category after the grace period ends, if the certificate is still valid?
A4. Yes