PMDA
日本醫藥品醫療器材綜合機構
Japan
Last reviewed 2026-08-05
日本PMDA根據PMD法案對醫療器材申請進行科學審評。日本使用四級分類體系，三條路徑：I類届出（通知）、II類認證（第三方認證）、III-IV類承認（PMDA/厚生勞動省批准）。日本是全球第四大醫療器材市場。
PMDA VS MHLW ROLES
PMDA performs scientific review and consultation; MHLW issues formal marketing authorizations under the PMD Act. Foreign manufacturers cannot hold approvals directly—they appoint a Japanese Designated Marketing Authorization Holder (DMAL) responsible for quality, PMS, and AE reporting.
SHONIN, NINSHO, AND TODOKEDE
Class I devices use notification (Todokede). Many Class II devices follow Ninsho third-party certification against published standards. Higher-risk Class III/IV typically require Shonin with full PMDA review (often 12–24 months). Mapping FDA Class II/III to Japan’s four-class system is a frequent source of planning error.
WHAT TO MONITOR
Teams track consultation outcomes, new certification standards, QMS ordinance expectations, and post-market safety information. Language and local representation make Japan a multi-quarter investment even when FDA/EU files already exist.
器材分類
Class I, II, III, IV
審批路徑
Todokede / Ninsho / Shonin
核心監管職能
- ▸承認上市前批准
- ▸認證第三方認證
- ▸QMS檢查（厚勞省令169號）
- ▸PMDA諮詢（對面助手）
- ▸外國製造商註冊
§ RELATED INTELLIGENCE
§ FAQ
What is PMDA in Japan?
The PMDA (Pharmaceuticals and Medical Devices Agency) is Japan's scientific review body for medical devices and pharmaceuticals. Operating under the PMD Act, PMDA conducts technical reviews of device applications, provides regulatory consultation (Taimen Joshu), and manages post-market safety surveillance. Final regulatory approvals are issued by the MHLW (Ministry of Health, Labour and Welfare).
What is the difference between Shonin and Ninsho in Japan?
Shonin is PMDA/MHLW pre-market approval, required for higher-risk devices (Class III and IV). It involves full PMDA scientific review and takes 12–24 months. Ninsho is third-party certification by a Registered Certification Body (RCB) for moderate-risk Class II devices, typically taking 6–12 months. Class I devices only require notification (Todokede) to the prefectural government.
How are medical devices classified in Japan?
Japan uses a four-class risk system: Class I (general medical devices — lowest risk), Class II (controlled medical devices — moderate risk), Class III (specially controlled medical devices — high risk), and Class IV (specially controlled medical devices — highest risk, e.g. pacemakers). This differs from the FDA's three-class system and requires careful cross-mapping for international manufacturers.
What is a DMAL holder in Japan?
A DMAL (Designated Marketing Authorization Holder) is a Japanese legal entity that holds the marketing authorization for a medical device on behalf of the foreign manufacturer. The DMAL is responsible for regulatory compliance, quality assurance, post-market surveillance, and adverse event reporting in Japan. Foreign manufacturers cannot directly hold marketing authorizations — a Japanese DMAL is mandatory.
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