Last month, the Ministry of Health, Labor and Welfare of Japan officially announced it will join the Medical Devices Single Audit Program ("MDSAP") Pilot. The MDSAP initiative is intended to allow a recognized auditing organization to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of each regulatory authority participating in the pilot program. Four other regulatory authorities have joined the initiative: the U.S. FDA, Australia's Therapeutic Goods Administration, Brazil's Agencia Nacional de Vigilancia Sanitaria, and Health Canada. With the addition of Japan, the burden for quality management system investigations imposed by each country's regulatory authority is expected to decrease through consolidation into reviews conducted by a recognized MDSAP auditing organization.
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