--- title: "PMDA Definition & Meaning | MedTech Terms" description: "Japan's regulatory authority for medical devices, drugs, and regenerative medicine. Plain-English Regulatory definition for MedTech teams, with examples and rel" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pmda#term", "name": "Pharmaceuticals and Medical Devices Agency", "alternateName": "PMDA", "description": "PMDA conducts scientific reviews of marketing authorization applications and post-marketing safety for drugs and medical devices in Japan, working under the Ministry of Health, Labour and Welfare (MHLW).", "url": "https://medtechterms.com/terms/pmda", "termCode": "pmda", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/pmda#article", "headline": "PMDA, Pharmaceuticals and Medical Devices Agency", "description": "Japan's regulatory authority for medical devices, drugs, and regenerative medicine.", "url": "https://medtechterms.com/terms/pmda", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/pmda" }, "about": { "@id": "https://medtechterms.com/terms/pmda#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "Pharmaceuticals and Medical Devices Agency, PMDA, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "PMDA English site", "url": "https://www.pmda.go.jp/english/", "publisher": { "@type": "Organization", "name": "PMDA" } }, { "@type": "CreativeWork", "name": "IMDRF Documents", "url": "https://www.imdrf.org/documents", "publisher": { "@type": "Organization", "name": "IMDRF" } }, { "@type": "CreativeWork", "name": "RAPS Regulatory Focus", "url": "https://www.raps.org/news-and-articles/news-articles", "publisher": { "@type": "Organization", "name": "RAPS" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdsap#term", "name": "Medical Device Single Audit Program", "alternateName": "MDSAP", "url": "https://medtechterms.com/terms/mdsap" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/imdrf#term", "name": "IMDRF", "url": "https://medtechterms.com/terms/imdrf" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "Pharmaceuticals and Medical Devices Agency", "item": "https://medtechterms.com/terms/pmda" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/pmda#faq", "mainEntity": [ { "@type": "Question", "name": "What is the scope of PMDA's regulatory authority?", "acceptedAnswer": { "@type": "Answer", "text": "PMDA's authority covers the scientific review of marketing authorization applications for medical devices, in-vitro diagnostics, and pharmaceuticals, as well as their post-market safety under the Pharmaceutical and Medical Device Act (PMD Act)." } }, { "@type": "Question", "name": "How does PMDA interact with the Medical Device Single Audit Program (MDSAP)?", "acceptedAnswer": { "@type": "Answer", "text": "PMDA participates in MDSAP, accepting MDSAP audit reports as an alternative to its own QMS inspections for certain manufacturers and device classes, streamlining the regulatory process." } }, { "@type": "Question", "name": "What is the difference between Shonin and Ninsho approvals in Japan?", "acceptedAnswer": { "@type": "Answer", "text": "Shonin refers to the direct PMDA review and approval process for higher-risk medical devices (e.g., Class II designated, Class III, Class IV). Ninsho refers to certification by an MHLW-registered third-party certification body for certain moderate-risk (Class II) devices, with PMDA retaining an oversight role." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Pharmaceuticals and Medical Devices Agency [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)PMDA # Pharmaceuticals and Medical Devices Agency Japan's regulatory authority for medical devices, drugs, and regenerative medicine. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition PMDA conducts scientific reviews of marketing authorization applications and post-marketing safety for drugs and medical devices in Japan, working under the Ministry of Health, Labour and Welfare (MHLW). What the regulation says The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's primary regulatory body for medical devices and pharmaceuticals, operating under the Ministry of Health, Labour and Welfare (MHLW). The PMDA conducts pre-market reviews for marketing authorization and oversees post-market safety, aligning with the Pharmaceutical and Medical Device Act (PMD Act). PMDA also accepts [Medical Device Single Audit Program](/terms/mdsap) (MDSAP) reports as a substitute for parts of its own Quality Management System (QMS) inspections for eligible manufacturers. ## What this means in practice Japan classifies devices into Classes I–IV. Higher-risk devices require Shonin approval; many Class II devices use third-party Ninsho certification. PMDA accepts [MDSAP](/terms/mdsap) audits in lieu of QMS inspections for many manufacturers. ## Examples - A manufacturer of a Class III implantable device submits a Shonin application to PMDA, including comprehensive clinical data and manufacturing site information. - A company developing a Class II diagnostic imaging system opts for Ninsho certification by a registered third-party body, streamlining its pre-market review process through a trusted entity. - A MedTech company with an MDSAP certificate uses it to satisfy PMDA's QMS inspection requirements for their manufacturing facility, reducing the need for separate audits. Common pitfalls - • A common misconception is that PMDA only reviews Shonin (higher-risk) applications; however, PMDA also oversees Ninsho (third-party certified) devices through audits and vigilance. - • Manufacturers might overlook that while MDSAP is accepted, specific Japanese QMS requirements, as outlined in the PMD Act, still apply and must be met. - • Failing to understand the nuances between Shonin and Ninsho pathways can lead to delays in market access for MedTech products in Japan. - • Assuming that PMDA's focus is solely on pre-market approval, neglecting the significant post-market surveillance and reporting obligations it enforces, is a critical error. ## Frequently asked questions What is the scope of PMDA's regulatory authority? PMDA's authority covers the scientific review of marketing authorization applications for medical devices, in-vitro diagnostics, and pharmaceuticals, as well as their post-market safety under the Pharmaceutical and Medical Device Act (PMD Act). How does PMDA interact with the Medical Device Single Audit Program (MDSAP)? What is the difference between Shonin and Ninsho approvals in Japan? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory IMDRF International Medical Device Regulators Forum. ](/terms/imdrf)[ Quality & Risk Medical Device Single Audit Program(MDSAP) Single audit of a manufacturer's QMS satisfying multiple participating regulators. ](/terms/mdsap) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 PMDA· 1 IMDRF· 1 RAPS· 1 1. [1 PMDA English site Verified PMDA · pmda.go.jp ](https://www.pmda.go.jp/english/) 2. [2 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym PMDA Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=pmda) Learn in 60 seconds Card Lesson Quiz Japan's regulatory authority for medical devices, drugs, and regenerative medicine. - · Japan classifies devices into Classes I–IV. - · Higher-risk devices require Shonin approval; many Class II devices use third-party Ninsho certification. - · PMDA accepts MDSAP audits in lieu of QMS inspections for many manufacturers. Remember this Watch out: A common misconception is that PMDA only reviews Shonin (higher-risk) applications; however, PMDA also oversees Ninsho (third-party certified) devices through audits and vigilance. Related terms - [Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) - [IMDRF ](/terms/imdrf) You may also need Auto-suggested from Regulatory and shared keywords. - [Emergency Use Authorization(EUA) ](/terms/eua) - [Premarket Approval(PMA) ](/terms/pma) - [Ministry of Food and Drug Safety (Korea)(MFDS) ](/terms/mfds) - [Saudi Food and Drug Authority(SFDA) ](/terms/sfda) - [ANVISA(ANVISA) ](/terms/anvisa) - [Health Canada Medical Device Licence(MDL) ](/terms/health-canada-mdl) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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