How to Place a Medical Device on the Japanese Market in 2026: Marketing Authorization Holder versus Designated MAH under PMD Act Articles 23-2 and 23-2-17, Foreign Manufacturer Registration under Article 23-2-4 versus Drug Accreditation, Todokede versus Ninsho versus Shonin, Ordinance 169 and MDSAP, Official Yen Fees, and Why CE / 510(k) / NMPA / HSA Do Not Replace a Japanese Licence

Audience and operational decision: This guide is written for international medical device distributors, contract manufacturing (OEM/ODM) buyers, hospital procurement committees, and overseas regulatory affairs managers qualifying sterile single-use surgical and vascular consumables—such as disposable circumcision devices, surgical staplers, endovenous laser fibers, and perioperative wound products—for the Japanese market. It resolves the exact legal, technical, and commercial boundary conditions required to transition from foreign regulatory files (EU CE mark, US FDA 510(k), China NMPA, Singapore HSA, or Korea MFDS) to an authorized, inspectable, and lawful commercial placement in Japan under the Pharmaceuticals and Medical Devices Act (PMD Act).

The article is structured around twelve operational questions, statutory role definitions, official yen fee comparisons, and an audited due diligence checklist:

1. Does a CE mark, 510(k), NMPA certificate, HSA listing, MFDS licence or MDSAP certificate replace Japanese MAH licence or item notification, certification or approval?
2. Who may file: overseas manufacturer, Japanese MAH under Article 23-2, or a designated MAH under Article 23-2-17, and which Act articles actually name the roles?
3. When is Class I notification enough, when is Ninsho via a registered certification body enough, and when does even a Class II or III device need MHLW Shonin?
4. What leftover Accreditation of Foreign Manufacturers still means, and why device FMR is Article 23-2-4 registration with no PMDA inspection and no PMDA user fee
5. What ISO 13485 proves, what Ordinance 169 still requires, and what MDSAP can and cannot change in a Japanese QMS inspection
6. What official yen fees print on the device review table and the 29 May 2026 consultation table versus consultancy $30,000 / $20,000-$120,000 slogans
7. What a public PMDA 添付文書 row can and cannot prove, including a reusable circumcision clamp versus a VEMERIX stapler
8. Which 2025-2026 instruments actually changed the file: consultation-fee revision 29 May 2026, materials-change notice 30 January 2026, device conditional-approval operations, and why Act No. 37 of 2025 is not automatically a device-MAH article
9. Worked examples: a CE-marked circumcision ring versus an NMPA-only laser fiber, and a Class I aftercare SKU that must not inherit a copied NMPA class
10. Distributor checklist, MAH/DMAH agreement terms, and red flags before the first Japanese shipment
11. Where VEMERIX fits—and where due diligence still begins
12. Frequently asked questions

Does a CE mark, 510(k), NMPA certificate, HSA listing, MFDS licence or MDSAP certificate replace Japanese MAH licence or item notification, certification or approval?

In international medical device distribution, one of the most persistent procurement fallacies is the assumption that holding a recognized overseas regulatory clearance allows commercial shipment directly into Japan. International distributors and procurement agents frequently ask whether an EU CE mark under Regulation (EU) 2017/745 (MDR), an FDA 510(k) clearance letter, a China National Medical Products Administration (NMPA) Class II certificate, a Singapore Health Sciences Authority (HSA) SMDR listing, or a Republic of Korea Ministry of Food and Drug Safety (MFDS) licence can substitute for domestic Japanese authorization. The statutory answer under Japanese law is an unequivocal no ¹, ².

Medical device market access in Japan is governed strictly by the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960, commonly cited as the PMD Act or 医薬品医療機器等法, e-Gov in force 21 May 2026) ¹. Japan operates a dual-layered regulatory framework administered by the Ministry of Health, Labour and Welfare (MHLW, 厚生労働省) and the Pharmaceuticals and Medical Devices Agency (PMDA, 独立行政法人医薬品医療機器総合機構) ². The statute regulates both the corporate entity that releases the device into Japanese commerce and the specific medical device item itself:

• Entity Licence (製造販売業許可): Under PMD Act Article 23-2, no entity may place a medical device on the Japanese market without holding a valid Marketing Authorization Holder (MAH) licence issued by the prefectural governor matching the risk tier of the device ¹.
• Item Clearance (品目承認・認証・届出): Every individual device model must possess its own statutory pre-market clearance: a notification (届出, Todokede) under Article 23-2-12, a third-party certification (認証, Ninsho) under Article 23-2-23, or a ministerial approval (承認, Shonin) under Article 23-2-5 ¹.
• Foreign Site Registration (外国製造業者登録): Under Article 23-2-4, a foreign manufacturer of devices or IVDs for export to Japan may obtain MHLW registration per manufacturing site. For Shonin, Article 23-2-5(2)(ii) makes an unregistered site a statutory refusal ground. Confirm which manufacturing processes on the actual file require that registration; leftover English 'Accreditation of Foreign Manufacturers' is not the current device procedure ¹, ³.
• Quality System Compliance (QMS省令): Manufacturing facilities must demonstrate compliance with MHLW Ordinance No. 169 through a QMS inspection resulting in a 基準適合証 (Conformity Certificate) ¹⁸, ⁶, ⁸.

Overseas certificates provide valuable technical data, but they hold zero legal authority at Japanese customs or hospital loading docks. As analyzed in sister guides in this regulatory series, regulatory authorizations are jurisdiction-specific instruments: why an MFDS licence does not place the same device in Japan, why an HSA SMDR listing does not place the same device in Japan, even though Japan is an HSA reference agency, why an Australian ARTG inclusion does not place the same device in Japan, why a Canadian MDL and MDSAP certificate are not a Japanese MAH licence, why a UKCA certificate does not place the same device in Japan, and why an SFDA MDMA does not place the same device in Japan.

Similarly, verifying an overseas certificate confirms that document's authenticity in its native market, but does not satisfy Japanese law: how to verify the CE certificate that may support a Japanese technical file without replacing PMDA authorisation, why an NMPA registration does not classify or authorise the same device in Japan, why a 510(k) clearance is not a Japanese manufacturing-and-marketing licence, and why an ISO 13485 or MDSAP certificate is not Japanese QMS conformity by itself. While clinical evaluation reports, ISO 10993 biocompatibility studies, and ISO 11135 sterilization validation reports from an EU MDR technical file can be reformatted into a Japanese Summary Technical Documentation (STED) filing, the file must be submitted under Japanese statutory procedures.

Who may file: overseas manufacturer, Japanese MAH under Article 23-2, or a designated MAH under Article 23-2-17, and which Act articles actually name the roles?

A fundamental hurdle for non-Japanese manufacturers entering Japan is establishing who possesses legal standing to hold licences and submit regulatory filings. Under Japanese law, a foreign legal entity located outside Japan cannot act as a domestic Marketing Authorization Holder (MAH). The PMD Act provides two distinct corporate structures for placing medical devices on the market ¹:

Structure 1: Domestic Marketing Authorization Holder (製造販売業者 under Article 23-2). In this traditional model, an independent Japanese legal entity—such as a Japanese distributor, a commercial trading house, or the foreign manufacturer's incorporated Japanese subsidiary (KK)—holds the Article 23-2 licence. The Japanese MAH applies for and owns the product item licence (Todokede, Ninsho, or Shonin). The MAH assumes primary legal liability for releasing product lots into Japanese commerce, managing post-market surveillance, reporting adverse events, and maintaining quality records. Under Article 23-2, the MAH licence is classified into three distinct categories based on device risk ¹:

• Type 1 MAH Licence (第一種製造販売業): Required to market Class IV and Class III Specially Controlled Medical Devices (高度管理医療機器). Demands the highest level of regulatory staffing and quality oversight.
• Type 2 MAH Licence (第二種製造販売業): Required to market Class II Controlled Medical Devices (管理医療機器). Covers standard surgical consumables, laser energy accessories, and monitoring devices.
• Type 3 MAH Licence (第三種製造販売業): Authorized to market Class I General Medical Devices (一般医療機器) only.

Licensed Japanese MAHs operate a three-officer quality and vigilance structure: the General Marketing Compliance Officer (総括製造販売責任者, Soukatsu); the Quality Assurance Controller (品質保証責任者, Hinseki) under GQP / Ordinance 169 oversight; and the Safety Management Controller (安全管理責任者, Anzen) under Good Vigilance Practice (GVP), MHLW Ordinance No. 135. Those named officer duties sit in the GQP and GVP ordinances, not in the FMR operational page and not as English defined terms in Article 23-2 itself ¹, ¹⁸, ¹⁹.

Structure 2: Foreign Manufacturer Special Approval and Designated MAH (外国特例承認制度 under Article 23-2-17). For foreign manufacturers who do not wish to surrender product ownership to a local distributor, the PMD Act provides an alternative pathway under Article 23-2-17. Under this system, the overseas manufacturer applies for and legally owns the product approval (Shonin) or certification (Ninsho). However, because the foreign entity resides outside Japanese jurisdiction, Article 23-2-17 mandates that the foreign manufacturer must appoint a licensed Japanese entity to act as its Designated Marketing Authorization Holder (選任外国製造医療機器等製造販売業者, Sennin Gaikoku Seizou Iryoukiki-tou Seizou Hanbaigyousha) ¹.

In international consultancy marketing, this designated entity is almost universally referred to as a DMAH (or D-MAH). However, regulatory affairs managers must understand that DMAH is not a statutory term defined in the English or Japanese text of the PMD Act. It is an industry shorthand for the statutory designated MAH under Article 23-2-17. The designated MAH must hold the appropriate Type 1, Type 2, or Type 3 MAH licence under Article 23-2 and maintains the same statutory three-officer system (Soukatsu, Hinseki, Anzen) to supervise importation, domestic release, and vigilance reporting in Japan ¹.

The strategic commercial advantage of the Article 23-2-17 DMAH model lies in distribution flexibility. If a foreign manufacturer grants the product licence directly to a commercial distributor under Structure 1, the distributor owns the registration. If that commercial relationship deteriorates, transferring a Shonin or Ninsho from one distributor to another in Japan requires the original distributor's formal written cooperation—or a complete re-registration from scratch. Under Structure 2, an independent third-party regulatory service provider acts as DMAH. The foreign manufacturer retains ownership of the underlying licence and can appoint, replace, or add multiple non-exclusive Japanese distributors without re-filing the device approval. Under PMD Act Article 23-2-18, if the foreign manufacturer changes its designated MAH, it must submit a change notification to the MHLW within 30 days of the change ¹. For contract manufacturing programmes, understanding who is the legal manufacturer whose Japanese MAH must hold the item licence is the critical first step before any drafting begins.

When is Class I notification enough, when is Ninsho via a registered certification body enough, and when does even a Class II or III device need MHLW Shonin?

Device classification in Japan determines the regulatory submission pathway, review body, user fees, and clinical evidence threshold. Japanese medical device classification is established by MHLW ministerial notifications referencing the Japanese Medical Device Nomenclature (JMDN, 日本医療機器命名法) database maintained by PMDA ¹³. While Japan aligns broadly with GHTF/IMDRF risk categories (Classes I through IV), the operational classification rules differ significantly from FDA, EU MDR, and NMPA systems ².

Class I: Pre-Market Notification (届出, Todokede under Article 23-2-12). Class I devices present extremely low risk to the human body (e.g., non-medicated surgical drapes, basic scalpel blades, manual examination lights, elastic bandages). For these products, the Japanese MAH files a Todokede directly with PMDA ¹, ². There is no substantive technical review conducted by PMDA or an RCB prior to commercialization, and there is no PMDA review fee on the device user-fee table. The manufacturer and MAH must still maintain complete technical documentation, sterilization records (if labeled sterile), and biocompatibility data in their domestic files. Whether the foreign manufacturing site also needs Article 23-2-4 registration for a Class I file is confirmed against the current manufacturing-process rules; the hard statutory refusal in Article 23-2-5(2)(ii) is written for Shonin, not as a Todokede fee card ¹, ³.

Class II and Specified Class III: Pre-Market Certification (認証, Ninsho under Article 23-2-23). Japan utilizes an authorized third-party review model for devices that have established, published Japanese Certification Standards (認証基準, Ninsho Kijun) ¹, ². Certification reviews are conducted by Registered Certification Bodies (RCBs, 登録認証機関)—private organizations accredited by MHLW, such as TÜV SÜD Japan, BSI Group Japan, SGS Japan, and the Japan Quality Assurance Organization (JQA). If a Class II device (or a designated Class III device, such as certain orthopedic implants or balloon catheters with standards) conforms completely to an existing JMDN certification standard, the application is submitted to an RCB rather than PMDA. RCBs review technical performance against JIS (Japanese Industrial Standards) and relevant ISO/IEC standards, assess manufacturing QMS documentation, and issue an official Certificate of Certification (認証書).

Class II/III (Without Standards) and Class IV: Pre-Market Approval (承認, Shonin under Article 23-2-5). When a Class II or Class III device does not have a published certification standard, incorporates novel technological features, or asserts modified clinical indications, it cannot use the RCB Ninsho route ¹, ². It falls under MHLW Approval (Shonin) governed by Article 23-2-5. All Class IV devices—including implantable cardiovascular devices, endovascular stent-grafts, and critical life-supporting systems—require Shonin. For Shonin submissions, the technical dossier (formatted as Japanese STED) is submitted to PMDA's Office of Medical Devices. PMDA teams conduct comprehensive technical, preclinical, and clinical data reviews, verify foreign manufacturing QMS conformity, and issue a formal review report. The final marketing approval is granted ministerially by the MHLW ².

What leftover Accreditation of Foreign Manufacturers still means, and why device FMR is Article 23-2-4 registration with no PMDA inspection and no PMDA user fee

Foreign manufacturing site registration is an area rife with obsolete terminology and costly misunderstandings. In commercial discussions, overseas suppliers and international brokers frequently state: 'Our factory holds Foreign Manufacturer Accreditation (FMA) in Japan' or 'We are waiting for PMDA to schedule our Accreditation inspection.' These statements confuse current medical device law with historical pharmaceutical procedures and obsolete statutes ³, ⁴.

The Historical Root: Prior to the comprehensive 2014 amendments to the Pharmaceutical Affairs Law (PAL), foreign manufacturers of medical devices were subject to Accreditation of Foreign Manufacturers (外国製造業者認定, Gaikoku Seizougyousha Nintei). Under that legacy system, MHLW conducted documentary or on-site inspections of foreign facilities and charged substantial inspection survey fees ³.

The In-Force Statute: When the PMD Act came into effect in November 2014, medical devices and IVDs were legally separated from pharmaceuticals. Under PMD Act Article 23-2-4, foreign device facilities are subject to Foreign Manufacturer Registration (外国製造業者登録, FMR, Gaikoku Seizougyousha Touroku), NOT accreditation (認定) ¹, ³. The legal and operational differences are profound:

• FMR Is an Administrative Registration (登録): Unlike pharmaceutical accreditation, medical device FMR under Article 23-2-4 does not involve a technical or on-site factory inspection by PMDA ³. Once the administrative filing criteria are satisfied, the registration certificate is issued as submitted.
• Zero PMDA User Fee: The live Japanese operational page states that PMDA user fees are not required for device FMR and that applicants must not wire PMDA's bank account (機構あて手数料は不要 / 機構の銀行口座に振り込まない) ³, ⁵. Foreign factories that receive invoices for thousands of dollars in 'PMDA FMR inspection fees' are paying private consultancy markups, not statutory PMDA charges.
• National Taxes Only: The only government fees associated with FMR are national taxes paid to the Japanese treasury: Registration-and-Licence Tax (登録免許税) paid via national tax payment slip for a new registration, or Revenue Stamps (収入印紙) affixed for renewals, reissues, or certificate reprints ³, ⁵.
• 5-Year Validity and Renewal: An FMR certificate is valid for exactly 5 years. Renewal applications (Form 63-7) must be submitted to PMDA approximately 5 months prior to the expiration date ³.
• Relocation Equals New Registration: If a foreign manufacturing facility relocates to a new physical address—even within the same industrial park or city—Japanese law treats this as a brand-new registration requiring Form 63-5 and full registration tax, not an administrative address change ³.
• 30-Day Minor Changes: Administrative modifications that do not alter the physical facility boundaries (e.g., changes in corporate legal name, executive representative, or postal formatting) must be notified via a Change Notification (変更届) within 30 days at zero fee ³.

The Empty English PMDA Page Failure Case: Why does confusion persist across Google search results and AI Overviews? On 5 September 2026, the PMDA English page that still ranks for leftover 'Accreditation of Foreign Manufacturers' queries (https://www.pmda.go.jp/english/review-services/reviews/foreign-mfr/0001.html) had an extracted body that was empty apart from an FAQ heading ⁴. The live operational instructions are on PMDA's Japanese-language portal at https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0008.html ³. International consultancies and automated search tools that rely on the stale English title keep teaching fee-bearing 'Accreditation'. The operational Japanese document confirms that device FMR is an administrative registration with no PMDA inspection and no PMDA user fee ³.

The Mandatory Statutory Refusal Gate: Crucially, Foreign Manufacturer Registration is not an optional post-market formality. Under PMD Act Article 23-2-5(2)(ii), ministerial approval (Shonin) shall not be granted if any manufacturing site performing design, primary manufacturing, sterilization, or final packaging has not obtained registration under Article 23-2-3 (for domestic sites) or Article 23-2-4 (for foreign sites) ¹, ³. If an overseas factory does not hold a valid FMR certificate, PMDA will reject the device approval outright.

What ISO 13485 proves, what Ordinance 169 still requires, and what MDSAP can and cannot change in a Japanese QMS inspection

Quality management system compliance is the second mandatory pillar of Japanese device approval. Overseas manufacturers routinely present an ISO 13485:2016 certificate issued by a European notified body or international registrar and assume that their quality system is fully qualified for Japan. This assumption is legally incorrect. In Japan, the statutory quality standard is MHLW Ordinance No. 169 (医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令, Ministerial Ordinance on Standards for Quality Management Systems for Medical Devices and In Vitro Diagnostics) ⁶, ⁸.

While MHLW Ordinance No. 169 harmonizes its core structure with ISO 13485:2016, it adds Japan-specific statutory duties that a standalone ISO 13485 certificate does not discharge ¹⁸, ⁸:

• Domestic MAH Supervision: Ordinance 169 legally binds the foreign manufacturing facility to the Japanese MAH. The foreign facility must establish documented procedures to report nonconformances, product changes, and quality anomalies directly to the Japanese MAH's Quality Assurance Controller (Hinseki).
• Good Vigilance Practice (GVP) Interface: Procedures must ensure seamless reporting of adverse events, customer complaints, and field safety corrective actions to the Japanese MAH's Safety Management Controller (Anzen) in compliance with MHLW Ordinance No. 135.
• Document Retention and Japanese Records: Critical quality records, design files, and batch-release records must be retained for the periods defined in Japanese QMS and vigilance rules, and packaging, labeling, and package-insert specifications must be controlled in Japanese. This page does not invent a retention-year table from an unread Ordinance 169 clause extract.
• Domestic Release Authorization: The manufacturer cannot ship goods directly to healthcare facilities. Product must be received, inspected, and formally released by the Japanese MAH under documented release procedures.

QMS Inspection and the Conformity Certificate (基準適合証): To obtain a Shonin approval or Ninsho certification, the manufacturing facilities (both foreign production sites and the domestic MAH, as applicable) must undergo a formal QMS inspection (QMS適合性調査) conducted by PMDA (for Shonin) or an RCB (for Ninsho) ¹⁸, ⁶, ⁸. Successful completion results in the issuance of a QMS Conformity Certificate (基準適合証, Kijun Tekigoushou). Under PMD Act Article 23-2-5(6), failure to maintain QMS conformity is a refusal / withdrawal ground for the item licence ¹.

The Reality of MDSAP in Japan: Japan has participated in the Medical Device Single Audit Program (MDSAP) since June 2015, and PMDA has accepted MDSAP audit reports since 2016 ⁸. International manufacturers frequently over-interpret this participation, claiming that an MDSAP certificate 'waives Japanese QMS inspections.' The legal boundary is PMDA's December 2020 document, Acceptance of MDSAP audit reports in Japan (https://www.pmda.go.jp/files/000238276.pdf) ⁹:

• Document Reduction: Submitting a valid MDSAP audit report may lead to reduction of the QMS documentation required for PMDA's off-site inspection ⁹.
• Off-Site Audit Conversion: Submitting an MDSAP report may allow PMDA or the RCB to convert an otherwise mandatory on-site factory audit of an overseas facility into an off-site document evaluation (switching from on-site to off-site inspection) ⁹.
• Not a Waiver of QMS Filings: An MDSAP certificate does not exempt the applicant from filing a formal QMS application, paying statutory QMS fees, or obtaining a 基準適合証. It is an inspection optimization tool, not an exemption from Japanese law ⁹.

What official yen fees print on the device review table and the 29 May 2026 consultation table versus consultancy $30,000 / $20,000-$120,000 slogans

Dissecting the economic realities of Japanese market entry requires exposing the dramatic gap between official statutory government fees and commercial consultancy packages. On 5 September 2026, search engine baselines and Google's AI Overview on 'Shonin vs Ninsho medical device' recited standard consultancy marketing figures: 'about 3 months and around $30,000 for Ninsho' and '6 to 36 months / $20,000 to $120,000 for Shonin'. International distributors and procurement directors read these figures and assume they represent official fees charged by the Japanese government. They do not.

Those widely quoted USD figures represent private commercial fee bundles from regulatory consultancies (such as Asia Actual, Emergo, Pacific Bridge, and Freyr), combining professional consulting retainers, private RCB assessment charges, technical document translation markups, and applicant stop-clock delays. In contrast, the official statutory fee schedules published by PMDA—the device/IVD user-fee table (Japanese table revised 20 May 2022; English provisional translation as of August 2025) and the consultation table listed on the hub as revised 29 May 2026, while the English appendix header still prints 8 May 2025—present a granular yen structure ⁵, ⁶, ⁷:

As documented in Table 4, for a generic Class II or Class III device with approval standards, the total statutory PMDA review and conformity fees print as ¥526,400. That is not Google's around-$30,000 Ninsho slogan, and it is not an RCB certification invoice. For new Class IV devices the printed review plus conformity total is ¥17,721,200, plus overseas travel where an on-site inspection is conducted abroad. Those yen cells come from the official device user-fee PDF. They are not a blended 'Shonin costs $20,000 to $120,000' card ⁶.

A similar reality applies to review timelines. This page does not copy consultancy slogans of 'about 3 months for Ninsho' or '6 to 36 months for Shonin' as official PMDA service standards, and it does not invent a substitute 4-to-6 / 6-to-10 / 12-to-18-month table. The English class hub does not print those month targets. Any real administrative clock excludes applicant stop-clock (照会事項), FMR processing, QMS inspection, translation, and RCB scheduling. Read the live Japanese service-standard notice before putting a month cell in an RFQ.

What a public PMDA 添付文書 row can and cannot prove, including a reusable circumcision clamp versus a VEMERIX stapler

When conducting due diligence on potential OEM partners or verifying competitor registrations in Japan, international buyers frequently search PMDA's public medical device package insert database (医療機器添付文書情報検索, commonly known as kikiSearch) ¹⁰. However, an uncritical reading of kikiSearch leads to dangerous assumptions regarding shipping authorization and product ownership.

An independent census of a 7 June 2026 public PMDA non-drug document-manifest snapshot, recomputed 5 September 2026, establishes the architecture and volume of the Japanese public directory ¹⁰:

• 269,816 Total Document Records: Across all indexed non-drug healthcare sectors, the database comprises 257,679 medical device records, 12,012 in vitro diagnostic (IVD) records, and 125 regenerative medicine records.
• 88,974 Unique Approvals: Across these 269,816 document records, there are exactly 88,974 unique approval, certification, or notification numbers (承認・認証・届出番号).
• 249,245 Package Inserts (添付文書): Medical device package inserts represent 249,245 document entries across 85,163 unique device licences (the difference in row counts arises from historical package-insert revisions and parallel indexing in PDF and SGML formats).

The Legal Verification Boundary: A public 添付文書 listing in kikiSearch proves exactly one fact: that a licensed Japanese MAH has formally submitted and published an approved package insert for that specific product model. It does not grant shipping authorization or import rights to any other company. If an overseas factory sees that another trading firm has registered a device under an identical generic name, the overseas factory cannot ship its goods into Japan against that registration. Furthermore, presence in kikiSearch does not prove that the foreign factory's Foreign Manufacturer Registration is currently active, nor does it confirm that the MAH's QMS certificate is in good standing.

The Circumcision Clamp Case Study: To demonstrate how superficial database searches mislead procurement teams, consider disposable circumcision devices. A search of the entire snapshot for circumcision terminology (包皮切除) reveals exactly one unique approval number: licence number 12B3X10001000058, general name '再使用可能な包皮切除術中用クランプ' (Reusable intraoperative circumcision clamp), held by 株式会社エムエーコーポレーション ¹⁰. An inexperienced distributor might see this entry and conclude that circumcision staplers are registered in Japan. That single licence is a traditional reusable stainless-steel surgical clamp. It is not a modern single-use disposable circumcision stapler such as the public VEMERIX Circumcision Stapler, not a self-detaching ring such as the public VEMERIX Circumcision Device, and it has no connection to Weihai Medison Medical Equipment Co., Ltd. ¹⁰, ¹⁴, ¹⁵.

The Laser Fiber Case Study: Searching the snapshot for the exact Japanese generic nomenclature 'レーザ供給装置用光ファイバ' (Optical fiber for laser delivery system) reveals exactly two unique approval numbers: 21500BZZ00284000 ('コンタクトレーザーファイバー', held by 株式会社アルテック) and 21600BZZ00323000 ('医用レーザアクセサリー', held by 株式会社富士エス・エル・アイ) ¹⁰. Neither is a dedicated 1470 nm radial-emission endovenous laser ablation fiber listing for Weihai Medison, and neither is a VEMERIX Japanese item licence ¹⁶.

The Negative Verification Rule: Crucially, the absence of a brand name from kikiSearch does not mean a foreign manufacturer is barred or ineligible for Japan. It simply confirms that no Japanese MAH has yet completed an item clearance and published an insert for that specific SKU. Market entry due diligence must be grounded in primary statutory licences—the MAH's Article 23-2 licence, the overseas factory's Article 23-2-4 FMR certificate, and the specific Shonin/Ninsho certificate—not casual keyword queries on a public web directory.

Which 2025-2026 instruments actually changed the file: consultation-fee revision 29 May 2026, materials-change notice 30 January 2026, device conditional-approval operations, and why Act No. 37 of 2025 is not automatically a device-MAH article

Maintaining regulatory compliance in Japan requires separating genuine, in-force administrative notices from broad legislative overhauls that do not apply to medical devices. In 2025 and 2026, several regulatory instruments directly impacted device dossiers, while others have been widely mischaracterized by commercial commentators:

1. PMDA Consultation Fee Schedule Revision (hub date 29 May 2026): The PMDA user-fee hub lists the consultation / export-certificate table as revised 29 May 2026. The English PDF appendix header still prints 8 May 2025. Device examples on that English table include Simple Consultation at ¥39,400 and Pre-Development Consultation at ¥294,100 ⁵, ⁷. Foreign sponsors preparing Shonin submissions can use those meetings to ask whether foreign clinical data will be accepted; the meeting fee is not the Shonin review fee.

2. Materials-Change Notice (30 January 2026, 医薬機審発0130第1号): MHLW issued a complete revision of the medical-device raw-material change procedure ¹¹, ²⁰. 軽微変更届 is available only where the change does not affect essential quality, efficacy or safety. Five listed change types—including changes that increase existing risk, whose impact cannot be estimated, that exceed the intended-use or reimbursement category, whose therapeutic or diagnostic effect is not minor, or that are made to resolve a serious post-market defect—require at least a partial-change approval or certification, and some require a new application. A self-declaration of the quality/efficacy/safety assessment must be attached. Biodegradable materials, implant materials, long-term-contact materials, biological materials and functional coatings sit in the cautious-handling group; they are not a generic 'swap an equivalent polymer and file in 30 days' shortcut. The statutory 軽微変更 notification clock is not a substitute for reading the notice, and this page does not invent a 6-to-9-month 一部変更 review cell.

3. Conditional Early Approval is a live index heading, not a 1 May 2026 operations memo copied here: PMDA's device-notifications index maintains a section on the medical-device conditional-approval system (条件付き早期承認制度) ²⁰. This page does not convert that heading, or Act No. 37 of 2025's 1 May 2026 staged implementation date, into an eligibility test, a start-date claim, or a 'robust real-world registry' operations rule without the underlying 医薬機審 notice.

4. Why Act No. 37 of 2025 is not automatically a device-MAH officer article: In 2025 the Diet passed Act No. 37 of 2025, amending aspects of the PMD Act ¹². e-Gov shows staged implementation dates, including 1 May 2026. MHLW overview materials for that Act are predominantly framed as pharmaceutical-system reforms. This page does not copy consultancy claims that device MAHs must immediately restructure executive leadership or appoint new 'supply-chain management officers' from that overview. The core Article 23-2 MAH licence types remain the placing-on-the-market test. Add a device-officer claim only from the device article or a device-specific ministerial ordinance.

Worked examples: a CE-marked circumcision ring versus an NMPA-only laser fiber, and a Class I aftercare SKU that must not inherit a copied NMPA class

To illustrate the Japanese rules on a sterile surgical consumable file, consider three public VEMERIX product profiles. These are filing-path contrasts, not Japanese classification certificates. NMPA class and any EU class analogue are not Japanese class, and this page does not assign a Japanese class, JMDN code, Shonin/Ninsho number or FMR number to a named SKU ¹⁴, ¹⁶, ¹⁷:

Worked Example 1: VEMERIX Circumcision Device (Self-Detaching Ring).

• Technical & Regulatory Profile: A single-use, biodegradable circumcision ring supplied EO-sterilized in individual blister packs across 14 size codes. The public product page records China NMPA Class II (Lu Mech Reg. 20172020238) and a CE mark ¹⁴.
• The Regulatory Fallacy: An international distributor assumes that because the device holds an EU CE certificate and is manufactured under ISO 13485, it can be imported directly into Japan under a simple notification.
• The Statutory Japanese Route: The CE mark grants no import authority. NMPA Class II and any EU class analogue are not Japanese class. The Japanese MAH or foreign manufacturer (via an Article 23-2-17 designated MAH) must classify the actual device under current JMDN/class rules, then file the matching 届出, 認証 or 承認. If a certification standard exists, the file may go to an RCB for Ninsho; otherwise it goes to PMDA/MHLW for Shonin. For Shonin, Article 23-2-5(2)(ii) makes unregistered manufacturing sites a refusal ground, so the Weihai site needs Article 23-2-4 FMR before approval can be granted. The CE technical dossier (ISO 10993, ISO 11135, shelf-life) can support the Japanese STED, but Ordinance 169 QMS inspection is a separate instrument. The public reusable-clamp listing (12B3X10001000058) cannot be reused ¹, ¹⁰, ¹³.

Worked Example 2: VEMERIX Disposable Medical Laser Fiber (1470 nm).

• Technical & Regulatory Profile: Single-use medical laser fiber for 1470 nm endovenous workflows, EO-sterilized, paired with a partner-supplied diode laser source. The public product page records China NMPA Class II (Lu Mech Reg. 20192010517) and no Medison CE claim ¹⁶.
• The Regulatory Fallacy: A distributor claims the fiber cannot enter Japan because it lacks an EU CE mark.
• The Statutory Japanese Route: Lack of a CE mark is not a Japanese filing bar. Japan does not mandate CE clearance as a prerequisite. Classify the fiber under current JMDN/class rules; a public-directory analogue family is レーザ供給装置用光ファイバ (two unique numbers, neither Weihai Medison). If certification standards exist, the file may proceed via RCB Ninsho; otherwise via PMDA Shonin. Compatibility evidence must match the intended laser source. The partner-supplied NOVACURE console is not a Medison-manufactured capital system; the consumable-fiber file is not a console Shonin ¹⁰, ¹⁶.

Worked Example 3: Circum-CARE Post-Op Protective Pants.

• Technical & Regulatory Profile: A purpose-built post-operative protective garment. The public product page records a China NMPA Class I filing (Lu Wei Mech Filing 20190014) ¹⁷.
• The Regulatory Fallacy: Sourcing managers assume that because it is Class I in China, it is automatically Class I in Japan and requires zero documentation.
• The Statutory Japanese Route: Classification cannot be copied from China or the EU. The Japanese MAH must match intended use and design to current JMDN definitions. If—and only if—the MAH classifies the garment as a Class I General Medical Device, the matching instrument is Todokede under Article 23-2-12, with no PMDA review fee on the device table. That is a classification decision, not a copied NMPA Class I. The MAH must still hold the matching Type 3 (or higher) MAH licence.

Distributor checklist, MAH/DMAH agreement terms, and red flags before the first Japanese shipment

To protect international buyers, distributors, and overseas manufacturers from costly compliance failures, the following 10-point due diligence checklist and contract framework must be executed before shipping the first commercial lot to Japan:

Essential Contract Terms for Regulatory Representation: When negotiating with a Japanese MAH or DMAH, overseas manufacturers must ensure the contract addresses four non-negotiable clauses:

• Ownership and Custody of Technical Dossiers: The contract must specify that all underlying design, preclinical bench testing, clinical evaluation files, and proprietary manufacturing records remain the exclusive intellectual property of the foreign manufacturer.
• Licence Transfer and Cooperation: If the Japanese partner acts as a direct MAH under Structure 1, the agreement must include an explicit, enforceable obligation requiring the MAH to transfer or surrender the Shonin/Ninsho upon contract termination without demanding financial ransom.
• Designated MAH 30-Day Transition Clause: If operating under the Article 23-2-17 DMAH model, the agreement must incorporate the statutory requirement of PMD Act Article 23-2-18, establishing a smooth 30-day notice procedure for transitioning regulatory responsibilities to a replacement DMAH without disrupting commercial customs clearance ¹.
• Vigilance Escalation and Audit Access: The contract must define precise complaint and adverse-incident transmission timelines sufficient for the MAH's Safety Management Controller (Anzen) to meet MHLW Ordinance No. 135, and should grant the foreign manufacturer audit rights over domestic release records ¹⁹.

Where VEMERIX fits—and where due diligence still begins

VEMERIX Positioning and Product Truth: VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care. Medison manufactures sterile single-use surgical and vascular consumables with public China NMPA registrations across multiple product categories; selected surgical lines also carry a CE mark ¹⁴, ¹⁵, ¹⁶.

In relation to the Japanese market, VEMERIX does not claim a Japanese MAH licence, FMR certificate, or item Shonin/Ninsho for these SKUs. The company's core sterile surgical lines—including the Circumcision Device (self-detaching ring, NMPA Class II, CE marked, EO sterilized), the Disposable Circumcision Stapler (NMPA Class II, factory EO sterilized), and the Disposable Medical Laser Fiber (1470 nm vascular consumable, NMPA Class II, no Medison CE claim)—are the files a Japanese MAH would actually receive. Medison's laser energy platform pairs its single-use fiber with a partner-supplied diode laser source, such as the NOVACURE console; VEMERIX does not manufacture or claim ownership of that partner-supplied capital console ¹⁴, ¹⁵, ¹⁶.

How VEMERIX Supports Japanese Market Access: While VEMERIX does not claim pre-existing retail distribution licences in Japan, the company actively partners with Japanese Marketing Authorization Holders (MAHs), designated MAHs (DMAHs), trading houses, and international distributors to facilitate lawful market entry:

• FMR Facilitation: VEMERIX provides complete factory documentation, legal entity records, plant layout drawings, and Japanese agent power-of-attorney forms to secure Foreign Manufacturer Registration (FMR) under PMD Act Article 23-2-4 via PMDA.
• Complete Technical Dossiers: VEMERIX supplies comprehensive preclinical bench testing, ISO 10993 biocompatibility test reports, ISO 11135 ethylene oxide sterilization validation reports, and ISO 11607-1/-2 sterile-barrier shelf-life validation data formatted for Japanese STED assembly.
• Ordinance 169 Inspection Support: Manufacturing, production-control and quality records can be assembled for an Ordinance 169 QMS inspection by PMDA or an RCB. That is a file-readiness statement, not a claim that VEMERIX already holds a Japanese 基準適合証.
• Bilingual Regulatory Cooperation: VEMERIX's regulatory affairs team collaborates directly with the Japanese MAH's Hinseki and Anzen officers to execute formal Quality Agreements (取り決め書) and establish rapid change-notification workflows.

Due diligence begins with an open, technical evaluation. International distributors and Japanese regulatory teams are invited to review our quality systems, request technical file summaries, and initiate Japanese regulatory planning through our Quality & Regulatory Hub or by contacting our team directly via Contact VEMERIX.

Frequently asked questions

Do I still need Japanese listing if my device already has a CE mark, FDA 510(k) or NMPA certificate?

Yes. A CE mark under EU MDR, an FDA 510(k) clearance, a China NMPA registration, a Singapore HSA listing, or a Korea MFDS licence carries zero legal validity at Japanese customs. Japan operates an independent regulatory framework under the PMD Act. Every device placed on the Japanese market must have its own statutory clearance (Todokede, Ninsho, or Shonin) held by a licensed Japanese Marketing Authorization Holder (MAH) or a foreign manufacturer appointing a designated MAH, the foreign factory must hold an Article 23-2-4 FMR certificate, and the quality system must comply with MHLW Ordinance No. 169.

Can the overseas manufacturer file directly, or must a Japanese MAH hold the licence?

An overseas manufacturer cannot file independently without a licensed Japanese entity. Under PMD Act Article 23-2, domestic market placement requires a Japanese entity holding a Type 1, Type 2, or Type 3 MAH licence. However, under the Article 23-2-17 Foreign Manufacturer Special Approval pathway, the overseas manufacturer can legally hold and own the product approval, provided it formally appoints a licensed Japanese entity to act as its Designated Marketing Authorization Holder (選任外国製造医療機器等製造販売業者, commonly referred to as DMAH).

Is DMAH a legal role in the PMD Act, or only consultancy English?

DMAH is an industry and consultancy English shorthand; it is not a defined statutory term in the text of the PMD Act. The actual statutory role is established under PMD Act Article 23-2-17 as the 'Designated Marketing Authorization Holder' (選任外国製造医療機器等製造販売業者). This designated entity must hold a valid Japanese MAH licence under Article 23-2, employ the three statutory officers (Soukatsu, Hinseki, Anzen), and assume domestic post-market and release responsibilities. Changing the designated MAH requires a 30-day notice under Article 23-2-18.

Is Foreign Manufacturer Accreditation still the current device process?

No. Under the 2014 PMD Act revision, medical devices and IVDs were transferred from the obsolete 'Accreditation of Foreign Manufacturers' (認定, Nintei) framework to 'Foreign Manufacturer Registration' (登録, Touroku) under PMD Act Article 23-2-4. Device FMR involves no PMDA on-site audit, incurs zero PMDA review fees, and is valid for 5 years. While PMDA's English website still hosts an empty page titled 'Accreditation of Foreign Manufacturers', current operational rules published on PMDA's Japanese site establish that device FMR is an administrative registration with no PMDA user fee.

Does ISO 13485 or MDSAP replace Ordinance 169 QMS inspection?

No. Standalone ISO 13485 certification does not equal compliance with MHLW Ordinance No. 169, which includes Japanese-specific requirements for MAH reporting, GVP Ordinance 135 interfaces, document retention, and domestic release. Under PMDA's December 2020 regulatory policy, submitting an MDSAP audit report may allow PMDA or an RCB to convert an on-site factory audit to an off-site document evaluation and reduce documentation volume, but it does not waive QMS review or eliminate the requirement to obtain a 基準適合証 (Conformity Certificate).

How much are PMDA device review and QMS fees in yen as of the current official tables?

Under the official PMDA device user-fee table (Japanese table revised 20 May 2022) and the consultation table listed as revised 29 May 2026, Class I Todokede incurs ¥0 in PMDA review fees. Generic Class II/III Shonin with approval standards prints ¥437,000 plus ¥89,400 conformity (total ¥526,400). New Class IV Shonin prints ¥16,431,300 plus ¥1,289,900. New-device QMS inspection prints ¥386,600, and simple device consultations print ¥39,400. Widely cited consultancy slogans of '$30,000 for Ninsho' or '$20,000–$120,000 for Shonin' are private service bundles, not those government cells. Ninsho fees are set by the chosen RCB and do not appear on the PMDA yen table ⁶, ⁷.

Does another company's public 添付文書 row cover my shipment of the same model?

No. A public package-insert (添付文書) listing on PMDA's kikiSearch database is a healthcare document index; it is not a transferable import licence. A manufacturer cannot ship devices to Japan against another company's approval number. Each commercial distribution channel must trace back to an authorized Shonin, Ninsho, or Todokede held by the manufacturer's own MAH or DMAH. Furthermore, searching kikiSearch for circumcision devices reveals only one reusable surgical clamp (`12B3X10001000058`), which has no connection to modern single-use circumcision staplers.

Does VEMERIX already hold a Japanese MAH licence, FMR certificate or item Shonin/Ninsho for these SKUs?

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., manufacturing in Weihai, China, with public NMPA Class II registrations on flagship surgical lines and CE certification on selected SKUs. VEMERIX does not claim a Japanese MAH licence, FMR certificate, or item Shonin/Ninsho for these SKUs. The company partners with Japanese MAHs, designated-MAH service providers, and distributors by providing technical dossiers, biocompatibility data, sterilization validations, and factory documentation for Article 23-2-4 FMR and Todokede/Ninsho/Shonin filings.