Quality System Assessment for Japanese PAL Compliance
Intertek can help you gain market clearance under Japan's Pharmaceutical Affairs Law (PAL) quickly and efficiently.
When trying to enter the Japanese market, many medical device manufacturers experience delays due to rigorous regulatory evaluations, extensive applications, and an unpredictable approval process. In an industry where product life cycles are continually becoming shorter, the time lost to these regulatory roadblocks could easily keep you out of Japan - the second largest market in the world for medical devices.
Fortunately, Intertek is ready and qualified to help. Our partnership agreement with Nanotec Spindler Co. Ltd., a recognized certification body (RCB) in Japan, enables us to perform audits according to Japan's adaptation of ISO 13485:2003.
With Intertek, you can have a single audit to meet all of your global market access needs, reducing total audit time and assuring consistency in interpretation across all standards. What's more, by using an Intertek auditor in the U.S. or Europe who is qualified through Nanotec Spindler and registered with the MHLW, you'll save significant time and expense compared to having an auditor travel to your facility from Japan.
With a high level of technical expertise and an unparalleled focus on customer satisfaction, Intertek will help you quickly and efficiently meet the requirements for Japanese market entry.
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