Medical Devices and Compliance with Japan’s PAL Regulations

Understanding the regulatory requirements of the Japanese medical device market

Japan is the second largest medical device market in the world, with medical devices imported from outside of Japan representing a substantial percentage of total market share.

Japan’s PMD Act

As of 25 November 2014, the Japanese Pharmaceutical Affairs Law (also known as PAL) was revised, with its title changed to the “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (abbreviated as the PMD Act). The PMD Act provides the legal framework for the regulation of medical devices, in vitro diagnostic reagents, pharmaceuticals, drugs and cosmetic products as well as regenerative and cellular therapy products in the Japanese market. Administration and oversight of the PMD Act legal framework is the responsibility of Japan’s Ministry of Health, Labour and Welfare (MHLW). Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory agency that works together with MHLW. It conducts scientific assessments of marketing application of pharmaceuticals and medical devices, monitoring their post marketing safety.  

For more information about the Japanese regulation changes, please refer to our Med-Info on the “New Act on Medical Devices in Japan”.

Regulatory requirements

Japan’s medical device classification system is based on Japanese Medical Device Nomenclature codes, which differ somewhat from the classification schemes used in the U.S. or the European Union. As of April 2005, third--party registered certification bodies (RCBs) are permitted to evaluate Class II devices and conduct marketing certification required to legally sell medical devices in Japan. In order to be certified, medical devices must demonstrate compliance with specified Japanese Industrial Standards (JISs), which define product safety and performance requirements. RCBs are also permitted to evaluate Class III “me-too” medical devices and provide marketing certification services as of 25 November 2014. In order to be certified, Class III “me-too” medical devices must demonstrate compliance with essential requirements, which have been harmonised to Global Harmonization Task Force (GHTF) documentation. Substantial equivalency to similar medical device(s) already legally marketed in Japan is also required.

In addition, companies must register their manufacturing sites located outside of Japan and obtain a manufacturer’s registration from the PDMA if the site performs one of the following functions:

• Design and development
• Production or sterilisation of medical devices
• Design and development or filling of in-vitro diagnostic reagents

Manufacturers based outside of Japan must also appoint a marketing authorisation holder (MAH), a company based in Japan who is the legally responsible party for certified medical devices. The MAH and registered manufacturing sites must establish and implement quality management system based on Japanese QMS ordinance.

Revised J-QMS Ordinance.

Why choose TÜV SÜD

TÜV SÜD Japan was the first Certification Body registered by Japan’s Minister of Health, Labour and Welfare, and is an RCB for all Class II medical devices, Class III medical devices and in¬vitro diagnostic reagents. TÜV SÜD Japan is one of the leading RCBs in Japan, based on the number of marketing certificates issued each year, and TÜV SÜD group subsidiaries collectively have the largest number of J-QMS auditors on staff. These credentials, along with TÜV SÜD’s global network of medical device technical experts, provide manufacturers worldwide with an effective single source for assistance in the assessment and certification of medical devices in accordance with Japan’s requirements. 

Click here to find out how to transfer to TÜV SÜD, the Notified Body of choice.

Our services at a glance

• Marketing certification services - TÜV SÜD Japan is accredited by the MHLW to evaluate Class II medical devices, Class III medical devices and in vitro diagnostic reagents, and to issue marketing certificates to those products that meet Japan’s rigorous requirements.
• J-QMS audit services - Through TÜV SÜD group subsidiaries, TÜV SÜD Japan is authorised to conduct audits of quality management systems for compliance with Japan’s QMS ordinance.
• Other testing and certification services - In addition to assessment and certifying medical devices to PMD Act requirements, TÜV SÜD Japan can also provide product safety and EMC testing for active medical devices according to Japanese Industrial Standards (JISs).

Your benefits at a glance

• MHLW accredited - Since 2005, TÜV SÜD Japan has been accredited by Japan’s MHLW to assess and certify Class II medical devices and in vitro diagnostic reagents. Since 2014, TÜV SÜD Japan has also been accredited to assess and certify Class III medical devices.
• Audit expertise - TÜV SÜD Japan and TÜV SÜD group subsidiaries conduct audits required under a number of international regulations and standards, including J-QMS, ISO 9001, ISO 13485, ISO 14001 and others. Often, required audits can be coordinated to reduce downtime.
• Single source solution - TÜV SÜD offers testing services for major medical device markets according to international standards and regulations.

• Regional and local proficiency - Our regional medical health experts speak your local language and understand regional and local regulations and knowledge needs.