Japan renews its participation in MDSAP until 2020

02 May 2019 |


Japan’s participation in MDSAP (Medical Device Standardized Audit Program) has been a contributing factor in the exponential update of MDSAP by multinational companies. Japan’s MHLW and PMDA has been opting in to participate in MDSAP on an annual basis, since 2015.

Japan leverages MDSAP by reducing the need for on-site audit of QMS to an off-site Audit, except for Registered Manufacturing Sites (RMS) which manufacture human/animal derived medical devices, radioactive IVDS or a Marketing Authorization Holder (MAH). However, PMDA reserves the right to determine if an on site inspection is necessary on a case by case basis. Click here for more information from PMDA or see our webinar on this topic.

As of this year, they have confirmed that it will continue to recognize MDSAP for QMS compliance “to reduce the burden on medical device manufacturers” from onsite audits to off-site inspections until March 31st, 2020. Click here for Japanese notice.

It is important to note that Japan’s long term recognition of MDSAP is still in flux as the interaction between this and the anticipated MHLW Ministerial Ordinance No. 169 (MOA169), titled “Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents” is yet to be determined. The purpose of the establishment is to make Medical Device QMS requirements be harmonized to ISO13485. Although the requirements are substantially equivalent to ISO13485, it includes many additional requirements specific to Japan.

It is clear that Japan continues to see the value of MDSAP to reduce the burden of auditing and leverage international information. However, it still remains to be seen how it will continue to recognize/use MDSAP once the new ordinance is issued. At the moment, it is scheduled to go for public comment this year (2019).

MDSAP continues to provide great benefits to organizations opting to participate in it. The program is voluntary, with the notable exception of Canada, which requires any organization selling medical devices in Canada to have MDSAP certification.

Brandwood Biomedical has taken numerous organizations through the program, and we find it to be very straightforward given that the gaps between ISO13485 and MDSAP are very manageable. Our streamlined and efficient MDSAP compliance program reduces a lot of the uncertainty facing the company’s regulatory teams when trying to implement this novel and innovative program on their own. Let us support you on this implementation, call or email us to schedule a free consultation to see if we can help your implementation process or even to discuss if MDSAP is for you.

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