Pharmaceuticals and Medical Device Law (PMDL)
Mandatory Medical Device Approval

Only applications from Japan-based Marketing Authorization Holders are acceptable and an application form and related documents must be written in Japanese.

Application for Certification of Medical Devices pursuant to PAL

Application Flow

* Surveillance audits are conducted annually and a renewal audit will be conducted before the end of the validity term (5 years).

Application for Custom Testing of Medical Devices

Application Flow (for Testing)

Custom test reports can be used in approval/certification applications and as testing data for internal use.

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