For Faster Regulatory Treatment for Medical Devices

Taiwan should adopt the MDSAP multilateral approach to plant audit reports.

In this year’s Taiwan White Paper, AmCham Taipei’s Medical Devices Committee called attention to problems arising from Taiwan’s documentary requirements for medical device companies to qualify to utilize the government’s simplified approach to auditing manufacturing facilities in the United States. As part of the process, the Taiwan Food and Drug Administration (TFDA) has ruled, the companies must obtain and submit an Establishment Inspection Report (EIR) from the U.S. FDA.

The catch is that the U.S. FDA is no longer making such reports available. As a consequence, companies seeking to import their U.S.-made medical devices into Taiwan have been unable to take advantage of the simplified Quality System Documentation (QSD) system. Instead, they have been subject to a more onerous and time-consuming regimen.

As a solution, the Committee proposed in the White Paper that Taiwan take advantage of an alternative auditing approach, the Medical Device Single Audit Program (MDSAP) that was developed by the U.S. FDA and adopted by IMDRF (the International Medical Device Regulators Forum). Member regulatory bodies of IMDRF have either already accepted the auditing standards necessary to participate in the MDSAP program or have committed to a timeline for doing so.

Besides the U.S. FDA, the current MDSAP participants are the relevant auditing organizations in Australia, Brazil, Canada, and Japan. A regulatory audit report issued by any of these bodies is accepted by all of them as the equivalent of an EIR.

TFDA has expressed interest in joining IMDRF in line with Taiwan’s desire to take part in as many international organizations as possible. But so far Taiwan has refrained from committing to set the auditing standards that are the heart of the IMDRF initiative, making its acceptance as a member unlikely.

The Medical Device Committee continues to urge TFDA to accept MDSAP reports instead of U.S. FDA EIR reports for applications for treatment under the simplified QSD framework. Following that course of action would bring several significant benefits. It would enable medical device companies to bring innovative new products to Taiwan in more timely fashion, enabling Taiwanese patients to gain access to the latest medical procedures. In addition, Taiwan’s participation in the MDSAP system would make it easier for domestic Taiwan manufacturers of medical devices to introduce their products to key overseas markets.