Japanese Pharmaceutical Affairs Law (PAL)

Is Your Medical Equipment Certified in Japan?

Doing business in another country presents many challenges, especially for medical device manufacturers. Navigating through regulatory requirements and local laws can be time consuming and expensive. TÜV Rheinland with its worldwide network of experts has a global view of the ever changing requirements of the most important markets in the world. We can assist pharmaceutical and medical device manufacturers with Japan’s Pharmaceutical Affairs Law (PAL).

The Japanese Pharmaceutical Affairs Law established regulatory requirements necessary for the manufacturing and distribution of medical devices and pharmaceutical products in Japan. The intent of the PAL is to harmonize requirements and reduce some of the conflicting demands by incorporating the guidance documents of the Global Harmonization Task Force (GHTF), including the quality management systems requirements based on the ISO 13485:2003.

TÜV Rheinland is registered with the Japanese Minister of Health, Labor, and Welfare as a Third-Party certification body. We can perform your “controlled medical device” certification, according to revised PAL Article 23-2 and ISO 13485 certification, as required in the revised PAL.

Benefits at a Glance

With Japanese PAL services from TÜV Rheinland, you can:

  • Gain market access into Japan, one of the largest economies in the world.
  • Ensure compliance with the Japanese Pharmaceutical Affairs Law including various safety measures such as Good Clinical Practices (GCP), Good Quality Practices (GQP), Good Vigilance Practices (GVP) and ISO 13485:2003
  • Minimize risk with proper documentation and compliance to safety standards
  • Benefit from our fast audit times, years of experience and global presence
  • Save significant cost and time by using a single source for all your testing and compliance needs

Our Services for Japanese PAL

TÜV Rheinland is registered with the Japanese Minister of Health, Labor, and Welfare as a Third-Party certification body. Delivered by knowledgeable and experienced experts, our services include:

  • Assessment of the safety and effectiveness of the medical device
  • Assessment of the manufacturer’s quality management system compliance with the ISO 13485 norm and specific deviations of Japanese regulations

Approach

TÜV Rheinland’s approach is as follows:

  • Determine the classification of your device according to the Japan Pharmaceutical Affairs Law (PAL).
  • Appoint a Marketing Authorization Holder (MAH) – company and device registrations must be done through the MAH, which controls device registration.
  • Submit application for “Foreign Manufacturer Accreditation.”
  • Implement the ISO 13485 Quality Management System (QMS), which also complies with PAL.
  • Prepare and submit pre-market approval application and registration dossier.
  • Conduct audit.
  • Issue pre-market certificate.

Two Components of the PAL Regulations

Japan’s Pharmaceutical Affairs Law (PAL) establishes regulations covering the manufacturing and distribution of medical devices and pharmaceutical products in Japan. This law was revised by the Minister of Health, Labor and Welfare and went into effect on April 1, 2005.

There are two components of the PAL regulations that are key to doing business in Japan: “Kyoka” and “Shonin”:

  • “Kyoka” – a kind of business license required for Marketing Authorization Holders (MAH), manufacturers, repairers, and distributors. If the manufacturing facilities are located outside of Japan, these foreign manufacturing facilities are required to obtain Foreign Manufacturer Accreditation instead of a Manufacturer License.
  • “Shonin” – to market medical devices in Japan, the MAH must register the device through the following procedures:
    • Pre-market submission (Todokede) - Class I medical devices
    • Pre-market certification (Ninsho) - Class II medical devices
    • Pre-market approval (Shonin) - Class II, III, and IV medical devices

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