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New to Japanese medical device regulation? This section explains the legal framework, the roles of the key regulatory bodies, and the pathways a device must follow to reach the Japanese market.
In this section
| Page | What you will learn |
|---|---|
| What is a Medical Device? | The PMD Act definition and how it applies in practice |
| What is Not a Medical Device? | Borderline products, quasi-drugs, cosmetics, and how PMDA handles grey areas |
| PMD Act — the Legal Definition | The statute, its history, and where to find the current text |
| PMDA vs MHLW — Who Does What? | How scientific review (PMDA) and regulatory authority (MHLW) are split |
| Regulatory Framework Overview | The full legislative hierarchy from PMD Act to MHLW notifications |
| Who Needs to Comply? | MAHs, manufacturers, RCBs, importers, distributors |
| Lifecycle of a Medical Device in Japan | From first classification decision to post-market re-examination |
| Approval vs Certification vs Notification | How to determine which of the three pathways applies to your device |
| Glossary | Key Japanese regulatory terms with English equivalents |