MDSAP Revision of MHLW MO169, Japan medical device QMS requirements
Date: 02 December 2022
MHLW MO169 has transitioned
MHLW Ministerial Ordinance 169 (MHLW MO169) was initially published in 2004 to ensure that Japanese medical device QMS requirements are harmonized with ISO13485:2003.
On March 26, 2021, MHLW MO169 was revised to align with the updated ISO13485:2016, with a transition period of 3 years for manufacturers. Visit the PMDA website.
This means that the deadline for manufacturers to make this transition is March 25, 2024.
If the transition has not been completed by this date, manufacturers will no longer be able to place products on the Japanese market.
Making the transition to MHLW MO169 (2021) – what do I need to do?
Here at BSI, we want to ensure that your transition to MHLW MO169 runs as smoothly as possible – and we are ready to start this process.
Transition audits will be conducted at your regularly scheduled annual assessment – either at your surveillance or recertification audit. This ensures that the process is as straightforward as possible for our clients. No additional time will be required to be added to your audit duration.
The BSI team leader who will conduct your annual audit will contact you directly to prepare the audit plan as per the normal process. Please notify them during this time that you are ready for transition to MO 169 (2021).
As our valued clients, you have the choice to start the transition over the course of the next few months or wait to start the process in 2023.
However, please do be aware that manufacturers who do not start the process this year will be required to transition in 2023, otherwise you will not be compliant with the new MO169 by its implementation date.
Once a recommendation has been made by the audit team and the MDSAP Regulatory Report goes through the independent review process, you will be issued a revised certificate with reference to the new MO 169 (2021). Certificate expiry dates will not be impacted by this transition and your on-going audit cycles will remain the same.
Please note, for transitions occurring during a surveillance audit, you will be charged the certificate issuance fee. For transitions occurring during a recertification audit, there will not be any additional fees and the certificate issuance fee will be combined for the transition and the certification reissuance.
If you have questions or concerns about your business’ transition to MHLW MO169, please refer to our MDSAP web page, where we will continue to share updates on vital changes to Medical Device Single Audit Programs. Alternatively, further information can always be provided via your BSI Account Manager – so please don’t hesitate to get in touch.
