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| The Japanese MHLW requires that all medical products sold in the country be registered. With the significant changes in the Pharmaceutical Affairs Law (PAL), the familiar process of obtaining KYOKA and SHONIN is changing. Included with these changes is the need to establish and register a "Marketing Authorization Holder" (MAH) or "Designated Marketing Authorization Holder" (D-MAH) in Japan. Functions of this entity differ significantly from the previous responsibilities of an In-Country Caretaker. In
addition, the MHLW indicates the need
for certain foreign manufacturing sites (involved with design
and manufacture of devices requiring new or modified approvals)
to be assessed and registered to
Ordinance 169 / ISO 13485. Obviously there are great challenges involved with this new and less-than-transparent approach that Japan is taking. The main challenges will likely include 1) setting up formal MAH's or D-MAH's to meet with PAL quality system requirements, 2) assessing and ensuring the MAH's level of compliance in Japan, 3) assessing and ensuring compliance of foreign manufacturing locations to ISO 13485:2003, 4) ensuring strong "change management" processes between the MAH and foreign manufacturer or head office. Solution:
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