FAQ
Frequently Asked Questions: Medical Device Regulatory Affairs in Japan
Questions about PMDA consultation, approval, certification, notification, JMDN, QMS, CER, and market entry in Japan.
Classification & JMDN
What is a JMDN code?+
A JMDN code identifies a generic medical device name. It is an important reference for classification, certification standards, comparable devices, and likely regulatory pathways, but the intended use, principle, performance, and risk must also be reviewed.
Does an existing certified device mean our device can use certification?+
Not necessarily. Intended use, design, performance, risk, conformity with the certification standard, and differences from existing devices require product-specific review.
PMDA & Submission
Is PMDA consultation always required?+
No. Its usefulness depends on novelty, differences from existing devices, uncertainty in the clinical evaluation, and the questions that should be clarified before submission.
Can overseas documentation be used in Japan?+
It may be usable after reviewing consistency with the Japanese intended use, patient population, comparable devices, applicable standards, and QMS requirements.
Clinical Evaluation & QMS
What is a CER?+
A Clinical Evaluation Report organizes the clinical assessment of a device using literature, existing clinical data, overseas documentation, and post-market information.
What structure does an overseas manufacturer need in Japan?+
Depending on the product and supply structure, a Japanese MAH or DMAH, foreign manufacturer registration, and QMS-related actions may be required.