You cannot import a medical device into Japan by clearing customs alone. The Pharmaceutical and Medical Device Act (薬機法, PMD Act) requires the device to carry a Japan-specific risk classification (Class I through IV) and a Japan-based Marketing Authorization Holder before the first shipment moves, and importing an unregistered device is a criminal offense, not a customs infraction. For a wearable or connected device, classification itself is often the first open question, since a consumer fitness product can cross into regulated territory without an obvious design change.
Why Is Importing a Medical Device Into Japan Different From a Standard Product Import?#
The fundamental rule: Japan's Pharmaceutical and Medical Device Act (薬機法 / PMD Act) prohibits the import of medical devices that have not been registered, certified, or approved by the relevant authority. This is not a customs rule - it is a criminal statute. Import of an unregistered medical device is a criminal offense.
The practical implication for market entry: Unlike general product imports where a physical good clears customs and post-market compliance follows, medical devices require regulatory status to be established before the first shipment can legally enter Japan.
Which Authorities Regulate Medical Device Import Into Japan?#
The PMD Act (薬機法): Formally the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, this is the primary statute governing medical devices in Japan.
PMDA: The Pharmaceuticals and Medical Devices Agency (独立行政法人 医薬品医療機器総合機構) is the technical review body responsible for evaluating medical devices for safety and efficacy before ministerial approval. PMDA conducts the review; MHLW (厚生労働省) grants the final approval based on PMDA's findings.
Competent authorities:
| Authority | Role |
|---|---|
| MHLW (厚生労働省) | Overall oversight; final approval authority for Class III and IV devices |
| PMDA | Technical review body for Class II, III, and IV |
| Registered Certification Bodies (RCB) | Third-party bodies for Class II certification under designated standards |
| Prefectural governments | Licensing authority for the Marketing Authorisation Holder (MAH) |
What Are Japan's Four Medical Device Risk Classes?#
All medical devices in Japan are classified into one of four risk classes under the PMD Act, and the class assigned determines the approval pathway, timeline, and cost. Classification is the first step in any import plan, since every downstream requirement, from Marketing Authorization Holder structure to review timeline, depends on it.
| Class | Risk Level | Examples | Approval Route |
|---|---|---|---|
| Class I | Lowest risk | Bandages, surgical gloves, examination gowns | Notification to MHLW (post-market) |
| Class II | Moderate risk | Diagnostic equipment, powered wheelchairs, contact lenses | RCB certification, or PMDA review |
| Class III | High risk | Dialysis equipment, non-life-sustaining orthopaedic implants | PMDA review + MHLW ministerial approval |
| Class IV | Highest risk | Pacemakers, implantable defibrillators, coronary stents | PMDA review + MHLW ministerial approval |
⚠️ Misclassification risk: The PMD Act classification does not map directly to US FDA or EU MDR/IVDR classes. A device that is FDA Class II may be PMD Act Class III in Japan. Class assignment requires a separate Japan-specific determination. Do not rely on foreign regulatory classifications.
Who Can Be the Marketing Authorisation Holder (MAH) for a Medical Device Sold in Japan?#
Only a Japan-resident entity can be the Marketing Authorisation Holder (MAH / 製造販売業者) for a medical device sold in Japan; a foreign manufacturer cannot self-register in that role. This is one of the most significant structural requirements for medical device import in Japan, and it is a corporate-structure question as much as a regulatory one, since a Japan IOR or import structure for medical devices has to be built around whoever holds the MAH role.
The rule: Every medical device sold in Japan must have a Japan-based MAH. The MAH is the entity that holds the marketing authorisation, bears product liability, and is responsible for post-market surveillance and adverse event reporting. A foreign manufacturer cannot self-register as the MAH; a Japan-resident entity is required.
What This Means for Foreign Manufacturers
A foreign company wishing to sell medical devices in Japan must:
Option A: Establish or designate a Japan-based entity as the MAH. This entity must hold a Manufacturing and Sales Business Licence (製造販売業許可) from the relevant prefectural government.
Option B: Partner with an existing Japan-based MAH (typically a local distributor or co-regulatory agent) who takes on the regulatory responsibility.
The MAH obligation is one of the primary reasons foreign medical device companies establish Japan subsidiaries, joint ventures, or distribution agreements before entering the Japan market.
How Long Does Japan Medical Device Approval Take?#
Japan's medical device approval timelines are among the longest in any major regulated market.
| Class | Typical Review Timeline | Notes |
|---|---|---|
| Class I (Notification) | 2-4 weeks | Self-declaration; no PMDA review required |
| Class II (RCB Certification) | 3-6 months | Third-party certification body review |
| Class II (PMDA Review) | 6-12 months | Where no designated standard exists |
| Class III (PMDA + MHLW) | 12-18 months | Full review; substantial equivalence or clinical data |
| Class IV (PMDA + MHLW) | 18-24+ months | Highest scrutiny; clinical trial data typically required |
📌 Priority review: PMDA offers an expedited "Sakigake" designation for innovative devices addressing unmet medical needs. Sakigake designation can reduce review time significantly but has strict eligibility criteria and is not available to all device types.
What QMS Standard Does Japan Require for Medical Devices?#
Class II and above devices must be manufactured under a Quality Management System (QMS) conforming to ISO 13485 as implemented under Japan's QMS Ordinance (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).
| Requirement | Class I | Class II | Class III | Class IV |
|---|---|---|---|---|
| QMS Ordinance compliance | No | Yes | Yes | Yes |
| PMDA QMS audit | No | Yes | Yes | Yes |
| Foreign manufacturer facility inspection | No | Yes | Yes | Yes |
Does a Foreign Medical Device Manufacturer Need MHLW Accreditation?#
Yes, for Class II and above devices, the foreign manufacturer must be accredited by MHLW under the Foreign Manufacturer Accreditation (外国製造業者認定) scheme before the marketing authorisation application can proceed. A wearable or borderline consumer device that turns out to sit in Class II or above triggers this same accreditation step even where the manufacturer did not originally design the product as a medical device.
| Step | Action | Timeframe |
|---|---|---|
| 1 | Confirm manufacturing facility meets QMS Ordinance requirements | Internal |
| 2 | Submit Foreign Manufacturer Accreditation application to MHLW | Day 1 |
| 3 | MHLW reviews application and facility documentation | 3-6 months |
| 4 | Accreditation granted: facility listed on MHLW accreditation register | Before MAH files marketing authorisation |
⚠️ The accreditation application must be submitted and approved before the MAH can file the marketing authorisation application. These two processes must be correctly sequenced or the marketing authorisation review cannot proceed.
Import Compliance Flow: Medical Devices#
Step 1: Classification
Determine Japan PMD Act class (I, II, III, or IV).
Do not rely on FDA or EU classification - assess independently.
│
Step 2: MAH Structure
Identify Japan-based MAH (existing entity or new setup).
Confirm MAH holds or will obtain 製造販売業許可 from prefecture.
│
Step 3: Foreign Manufacturer Accreditation (Class II+)
Apply for MHLW Foreign Manufacturer Accreditation.
Timeline: 3-6 months.
│
Step 4: Approval Application
Class I: notification to MHLW.
Class II: RCB certification or PMDA review application.
Class III/IV: PMDA review + MHLW ministerial approval.
│
Step 5: QMS Audit (Class II+)
PMDA audits foreign manufacturer's quality management system.
Japanese language documentation requirements apply.
│
Step 6: Approval or Certification Granted
MAH receives Class III/IV (製造販売承認) or Class II (認証) or Class I (届出).
│
Step 7: Import and Customs Clearance
Import declaration via NACCS.
Approval reference cited in customs documentation.
IOR or MAH-affiliated entity acts as legal importer.
│
Step 8: Post-Market Obligations
Adverse event reporting (不具合情報) to PMDA.
Periodic Safety Update Reports.
Post-market surveillance programme maintained.
Are In Vitro Diagnostics (IVD) Classified Differently in Japan?#
In Vitro Diagnostic devices (IVD) are classified under the PMD Act separately from other medical devices. Common IVD examples include blood glucose monitors, PCR test kits, and laboratory analysers.
Key differences for IVD:
- Japan's IVD classification has specific sub-categories that differ from EU IVDR
- IVD for in-house laboratory use (not commercial sale) may have different compliance pathways
- Confirm current regulatory status for any IVD given ongoing regulatory revisions in Japan
Do Cosmetics and Quasi-Drugs Follow the Same Import Rules?#
Two adjacent categories are also governed by MHLW under the PMD Act framework, and both require their own registration track separate from the medical device classes above:
| Category | Japanese Term | Key Requirement |
|---|---|---|
| Quasi-drug | 医薬部外品 | Pre-market approval from MHLW; applicable to certain medicated cosmetics, whitening products, anti-hair-loss treatments |
| Cosmetics | 化粧品 | Foreign manufacturer registration with MHLW; cosmetics import licence required |
Foreign cosmetic manufacturers operating in Japan must register with MHLW. An import licence (化粧品製造販売業許可) is required to commercially import cosmetics. This is distinct from general product import and cannot be satisfied by standard customs clearance alone.
Key points:
(a) Classification under the PMD Act (Class I through IV) is a Japan-specific determination, independent of FDA or EU MDR/IVDR class, and it decides every downstream requirement below it.
(b) A Japan-resident Marketing Authorisation Holder is mandatory for every device sold in Japan; a foreign manufacturer cannot self-register in that role and must either establish a Japan entity or partner with an existing MAH.
(c) For Class II and above, Foreign Manufacturer Accreditation must be granted before the marketing authorisation application can even be filed, so sequencing the accreditation and QMS audit steps early is what protects the overall timeline.
Compliance Checklist: Medical Device Import to Japan#
- Classify the device under Japan PMD Act Class I, II, III, or IV - independently of FDA or EU class
- Identify Japan-based MAH (existing distributor or establish new entity)
- Confirm MAH holds or applies for 製造販売業許可 from prefectural government
- For Class II+: submit Foreign Manufacturer Accreditation application to MHLW
- Confirm QMS Ordinance compliance and prepare for PMDA QMS audit
- File appropriate approval application (notification, RCB certification, or PMDA review)
- Do not import or commercially offer devices before the relevant approval status is confirmed
- Confirm IOR or import entity is MAH-affiliated or acts with MAH authorisation
- Establish post-market surveillance programme and adverse event reporting procedures before launch
- For IVDs: confirm current sub-classification and any applicable special registration procedures
- For cosmetics or quasi-drugs: confirm foreign manufacturer registration and import licence
Key Regulatory Reference Table#
| Framework | Authority | Scope |
|---|---|---|
| PMD Act (薬機法) | MHLW | Marketing authorisation, MAH requirement, import prohibition on unregistered devices |
| QMS Ordinance | MHLW | Quality management system requirements for Class II+ |
| PMDA | PMDA | Technical review for Class II, III, and IV devices |
| Food Sanitation Act (食品衛生法) | MHLW | Applies additionally for food-contact medical devices |
| 関税法 | MOF / Japan Customs | Import declaration |
Official References#
| Source | Link |
|---|---|
| MHLW - Medical Devices | mhlw.go.jp/english |
| PMDA - Medical Device Review | pmda.go.jp/english |
| MHLW - Foreign Manufacturer Accreditation | mhlw.go.jp |
| Japanese Law Translation - PMD Act | japaneselawtranslation.go.jp |
| Japan Customs - Import Procedures | customs.go.jp/english |
Frequently Asked Questions#
Can I import a medical device into Japan and get PMD Act approval afterward?
No. The PMD Act (薬機法) prohibits import of a device that has not already been registered, certified, or approved for its assigned risk class, and import of an unregistered device is a criminal offense, not a customs penalty that can be cured after the fact. Classification and the relevant approval or notification must be resolved before the first shipment moves.
Can a foreign manufacturer act as its own Marketing Authorisation Holder in Japan?
No. The MAH role requires a Japan-resident entity, so a foreign manufacturer must either establish or designate a Japan-based entity that holds a Manufacturing and Sales Business Licence (製造販売業許可) from the relevant prefecture, or partner with an existing Japan-based MAH such as a distributor willing to take on that regulatory responsibility.
Does a fitness tracker or consumer wearable ever need PMD Act approval?
It can, if the device's marketed function crosses from general wellness into a diagnostic or therapeutic claim, such as detecting a medical condition rather than tracking general activity. That reclassification carries the same MAH, accreditation, and approval-timeline consequences as any other Class II or higher device, which is why device function and marketing claims both need review before launch, not just the hardware design.
Conclusion#
Medical device import into Japan runs on a Japan-specific classification and a Japan-resident MAH requirement that cannot be satisfied by customs clearance alone, and the approval timeline for Class III and IV devices can run past a year, so classification and MAH structure need to be settled before a launch date is set, not after. Coordinating the classification, accreditation, and import structure is a scope our customs and regulatory filing coordination service supports alongside the MAH's own regulatory work.
This article is informational only and does not constitute legal, regulatory, or medical advice. The import of unregistered medical devices is a criminal offense in Japan. Consult a licensed attorney (弁護士) or qualified pharmaceutical and medical device regulatory specialist before importing any medical device into Japan. Last updated: September 2026.