Japanese Testing Services

The Pharmaceutical Affairs Law (PAL) of Japan requires that manufacturers who wish to sell medical devices have a Kyoka (Business License by Company), and a Ninsho (Certification by Product), or a Shonin (Approval by Product), depending on the type of device being registered (General, Controlled, or Highly Controlled Devices).

Toxikon has been providing Japanese testing services to the medical device industry for Japanese submissions for over 25 years. The company's data is well established from a technical perspective based on the prior Japanese Notification 99, and all Vertical standards relative to  product type.

With the recent changes to the PAL, there have been revisions to the Japanese standards, specifically with the new requirements of the Marketing Authorization Holder (MAH), formerly the In Country Caretaker (ICC), and updated testing standards.

Toxikon's testing protocols include all current updates to Japanese requirements. These updated standards require more specific information based on specificity, sensitivity, applicability of usage, and characteristics of the test materials. Tests are selected based on IYAKUSHINHATSU No. 0213001 (similar to ISO 10993-1) for Japanese selection of tests. Follow on testing is performed to Japanese protocols designed by Toxikon to meet product specific needs based on the revised testing standard, Notification 36, which includes all Japanese testing specifications. Any GLP requirements are based on the current Japanese device GLP, Ordinance 37.

Toxikon can also provide our clients with consulting contacts in Japan, who work directly with Ministry of Health, Labor and Welfare (MHLW) for any product submission requirements.