JPAL - Japanese Regulations for Medical Devices

Getting your products to market in Japan requires compliance with the Japan medical device regulations, known as the Japanese Pharmaceutical Affairs Law (JPAL) For an increasing number of device types, this requires certification from a JPAL Registered Certification Body (RCB).

SGS is a JPAL Registered Certification Body and we offer JPAL audits in Japan and globally through our network of local offices. We have a presence in every region around the globe, so your audits will be carried out in your local language.

The Japanese medical devices regulations allow approved bodies, such as SGS, to review the technical documentation and audit the manufacturing site of an increasing number of Class II medical devices and IVD reagents to give access to the Japanese market. JPAL auditing does not always follow the process recognized by manufacturers from schemes including CE Marking, CMDCAS, and ISO 13485. Differences include the application being made by the Japanese Market Authorisation Holder (MAH) rather than the manufacturer, and audits every 30 months. It is important to open discussions with us at an early stage to understand the benefits of SGS audits and certification in the Japanese market because we can help you achieve the correct certification at the right time.

An existing UKAS accredited ISO 13485:2003 certificate from SGS will normally lead to a reduced requirement for QMS assessment under JPAL.

Support your entry into Japan’s medical devices market with JPAL audits and assessment from SGS.

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