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