Glossary of Key Terms
Key Japanese regulatory terms with English equivalents and plain-English explanations.
Regulatory pathways
| Japanese (Romaji) | Kanji | English | Explanation |
|---|---|---|---|
| Shonin | 承認 | Approval | Pre-market approval for Class III/IV devices, issued by MHLW following PMDA review |
| Ninsho | 認証 | Certification | Pre-market certification for Class II devices (and some Class III), issued by an RCB |
| Todokede | 届出 | Notification | Pre-market notification for Class I devices, filed with prefectural government |
| Ichibu Henko | 一部変更 | Partial change approval | Application required before making significant post-approval changes to an approved device |
Key organisations
| Abbreviation | Japanese | English | Role |
|---|---|---|---|
| MHLW | 厚生労働省 | Ministry of Health, Labour and Welfare | Regulatory authority; issues approvals; sets policy and legislation |
| PMDA | 医薬品医療機器総合機構 | Pharmaceuticals and Medical Devices Agency | Conducts scientific review; QMS inspections; post-market safety surveillance |
| RCB | 登録認証機関 | Registered Certification Body | Third-party certification body for Ninsho applications |
Business licences and roles
| Japanese (Romaji) | Kanji | English | Explanation |
|---|---|---|---|
| Seizouhanbaigyo-sha | 製造販売業者 | Marketing Authorization Holder (MAH) | Japan-domiciled entity holding the approval/certification; bears primary regulatory responsibility |
| Seizou Gyosha | 製造業者 | Manufacturer / Manufacturing licence holder | Entity that manufactures the device; holds manufacturing licence |
| Kannin | 管理 | Licensed MAH / Kannin MAH | A third-party Japan entity acting as MAH on behalf of an overseas manufacturer |
| Gaikoku Seizousha | 外国製造業者 | Foreign manufacturer | Overseas manufacturing site registered with MHLW under FMR |
Key processes and systems
| Abbreviation/Term | Japanese | English | Explanation |
|---|---|---|---|
| FMR | 外国製造業者認定 | Foreign Manufacturer Registration | Registration required for overseas manufacturing sites supplying devices to Japan |
| GPSP | 製造販売後調査等基準 | Good Post-market Study Practice | Japan's framework for post-market surveillance studies and use-results surveys |
| JMDN | 日本医療機器命名制度 | Japan Medical Device Nomenclature | Japan's official device nomenclature and classification system |
| MO 169 | 省令第169号 | Ministerial Ordinance 169 / QMS Ordinance | Japan's QMS standard for device manufacturers; aligns with ISO 13485 |
| PMD Act | 薬機法 | Pharmaceuticals and Medical Devices Act | Primary legislation (Act No. 145 of 1960, as amended) |
| Yusen Shinsa | 優先審査 | Priority review | Expedited PMDA review for devices addressing unmet medical needs |
| SAKIGAKE | 先駆け審査指定制度 | SAKIGAKE designation | Breakthrough device designation for innovative devices; enables early consultation and expedited review |
Classification terms
| Japanese | English | Explanation |
|---|---|---|
| Ippan iryo kiki | 一般医療機器 | General medical devices (Class I) — lowest risk |
| Kanri iryo kiki | 管理医療機器 | Controlled medical devices (Class II) |
| Kodo kanri iryo kiki | 高度管理医療機器 | Specially controlled medical devices (Class III and IV) — highest risk |
| Taiko shindan yakuzaihin | 体外診断用医薬品 | In vitro diagnostics (IVDs) |
| Purogurammu iryo kiki | プログラム医療機器 | Programme Medical Device (Software as a Medical Device) |