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Getting your products to market in Japan requires compliance with the Japanese medical device regulations, known as the Act on Pharmaceuticals and Medical Devices (PMD Act).

Cargo and truck at harbour

For an increasing number of device types, this requires certification from a Registered Certification Body (RCB).

SGS is a PMD Act Registered Certification Body and we offer PMD Act 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 registered certification bodies, such as SGS, to review technical documentation and audit Japanese marketing authorization holders (MAH) and the manufacturing sites for an increasing number of Class II and III designated controlled medical devices and Class II designated IVD reagents to give access to the Japanese market. PMD Act auditing does not always follow the process recognized by manufacturers from schemes including CE Marking, and ISO 13485. Differences include the application being made by the MAH rather than the manufacturer, and re-certification audits are performed every 5 years. 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 certificate from SGS will normally lead to a reduced requirement for QMS assessment under the PMD Act.

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