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Medical Devices / Regulatory Affairs

Japan and Poland Sign Confidentiality Agreement in Move Toward MDSAP

Nov. 15, 2017

Japan and Poland signed a confidentiality agreement to share regulatory information in a move that will make it easier for Poland to participate in the Medical Device Single-Audit Program.

The agreement will facilitate the flow of information and documentation between Japan’s Ministry of Health Labor and Welfare and Pharmaceutical and Medical Devices Agency and Poland’s Office for Registration of Medicinal Products, Medical Devices and Biological Products.

Japan, which joined the MDSAP Consortium in June 2015, has been reaching out to global regulators to get them involved in the program.

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