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Intertek Systems Certification > Online Resources > Webinars > Archive Request: Japanese PAL
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Archive Request: Japanese PAL :

Whether you're bringing your product to Japan for the first time, or renewing an existing license, your company needs to be in compliance with the Japanese Pharmaceutical Affairs Law (PAL). Don't let the PAL's extensive applications and rigorous regulatory evaluations keep you out of Japan - the world's second-largest market for medical devices.

With this recording of Intertek’s webinar, you'll learn exactly what you need to do to make sure your products and processes are in compliance with the PAL. With a complete understanding of the regulations comes faster market access.

Our presenters are Ms. Chieko Spindler and Mr. Toshiaki Sasaki of Nanotec Spindler Co. Ltd., Intertek's certification-body partner. They will provide you with a concise overview of the product assessment and quality management system (QMS) audit processes for PAL compliance, including:

  • How medical devices are classified under the PAL
  • The certification scheme for Designated Controlled Medical Devices (DCMD)
  • The applications and forms that must be completed, and what technical product information you need to provide
  • What you can expect for your on-site QMS audit - and the most common findings

Watch this webinar online now by completing the form below. Fields marked with a red asterisk (*) are required.

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