Bringing a Medical Device or Drug to Market in Japan (2026 Guide)

Classification decides your route, and the route decides your schedule. That single sentence covers most of what a foreign company needs to understand about bringing a medical device or a pharmaceutical to market in Japan.

The mechanics are documented, the processing periods are published, and the pathway is not especially mysterious. What catches companies out is discovering late that a product sits one class higher than assumed, or that a planned change to an approved item requires a fresh approval rather than a notification. Those are not paperwork problems. They are multi-quarter schedule problems.

This guide sets out the licences, the routes, the foreign manufacturer step, and the published timings for each stage. It is the companion to our explainer on PMDA, which covers the agency itself rather than the process.

Step 1: You need a Japanese entity to hold the licence

Before any product question, there is a structural one. Market authorisation in Japan is held by a marketing authorisation holder (製造販売業者, commonly MAH), which must be a Japan-side entity. An overseas company cannot hold it directly.

That entity, not the overseas brand, carries legal responsibility for product quality, safety and labelling in the Japanese market. It must appoint the required responsible technical staff and maintain quality and safety management systems.

Two points that catch people out:

• Drugs and devices need separate licences. The marketing authorisation holder licence for pharmaceuticals sits under Article 12 of the PMD Act; the equivalent for medical devices sits under Article 23-2. A company selling both needs both. Renewals for each carry a published standard processing period of 20 days with a fee.
• You do not have to establish your own entity. Appointing a third party to act as MAH is common and legitimate. The trade-off is control: that party holds the authorisation, and moving it later is not trivial.

Step 2: Classification determines everything downstream

This is the decision that sets your timeline, and it is made on the product’s risk class, not on your commercial preference.

Medical devices: three routes

Class	Route	Legal basis	Standard period	Filings/year
Class I (general)	Notification (届出)	PMD Act Art. 23-2-12	notification	high volume
Class II (controlled)	Certification (認証) by a registered third party	Art. 23-2-23(1)	90 days	~761
Class III / IV (highly controlled)	Approval (承認) by MHLW on PMDA review	Art. 23-2-5(1)	10 months	~351

Certification and approval differ by a factor of roughly 3.4 in published time. The reason is what each involves. Certification (ninsho) assesses conformity to an existing recognised standard and is issued by a registered third-party body. Approval (shonin) is a fresh evaluation of safety and efficacy, reviewed by PMDA and granted by MHLW.

If your device can be brought within a recognised standard, the certification route is materially faster. Whether it can is a technical and regulatory question worth resolving early, because it is close to unchangeable once a design and an intended-use claim are fixed.

For in-vitro diagnostics, approval carries a published period of 12 months, with roughly 63 filings a year.

Pharmaceuticals: the clinical trial gate first

For drugs the sequence starts earlier. A clinical trial notification (治験計画届) under Article 80-2(2) carries a published standard processing period of 30 days with no fee, and around 558 are filed a year. That 30-day window is the point at which a Japanese development programme becomes visible to the regulator.

Amendments to a notified plan are processed in one day, with about 5,660 filed annually. The initial notification is the gate; changes after it are routine.

Step 3: The foreign manufacturer step, which is routinely underestimated

If the product is made outside Japan, two further obligations attach to the manufacturing site rather than to you:

Procedure	Legal basis	Standard period	Filings/year
Foreign manufacturer registration	Art. 23-2-4(1)	not published	~651
Foreign manufacturer registration renewal	Art. 23-2-4(2)	not published	~946
Device QMS conformity inspection	Art. 23-2-5(7)	6 months	~610
Drug GMP conformity inspection	Art. 22(1)	6 months	~3,900
Foreign-manufactured device approval	Art. 23-2-17(1)	10 months	~70

The six-month conformity inspection is the step most often left off a launch plan. It runs on your manufacturer’s documentation and its readiness to be inspected, which for a contract manufacturer means the timeline depends on a party you do not control. Starting that conversation at the same time as the regulatory submission, rather than after it, is the single most useful scheduling decision available here.

Step 4: Plan for the post-market obligations before launch, not after

Approval is the beginning of the obligation, not the end of it. The volumes give a sense of the scale:

• Medical device malfunction and infection reporting: roughly 337,900 filings a year, with a reporting standard of, in principle, the following day.
• Adverse reaction and infection reporting across drugs, quasi-drugs and cosmetics: roughly 1,205,000 filings a year, with a five-day standard.
• Product testing (検定) where required: 130 days, with about 993 filings a year.

A marketing authorisation holder must be resourced to meet these from day one. The reporting clocks are short, and they do not scale down for a company with a single product.

Step 5: The change-management trap

This is where launch plans most often break, and it is worth stating plainly because the ranges are severe.

Change type	Standard period
Device: partial change to a certification	45 days
Device: partial change to an approval	10 months
Drug: minor change notification (Art. 14(16))	1 week
Drug: partial change approval (Art. 14(15))	12 months

For drugs, that is a fifty-fold difference between a minor change and a partial change, and the drug figures show where the volume sits: about 21,232 minor change notifications a year against 3,083 partial change approvals. Most changes are handled as notifications. The ones that are not can cost a year.

Which category a proposed change falls into is a regulatory judgement, and it is one worth preparing for and arguing carefully rather than conceding at the first question.

What good planning looks like

Working back from a target launch:

• Resolve classification first. Device class, and whether a recognised standard applies, determines whether you are on a 90-day or a 10-month clock.
• Start the foreign manufacturer track in parallel, not sequentially. Six months of conformity inspection running alongside the submission is very different from six months added to the end of it.
• Decide the MAH structure early. Establishing an entity and appointing responsible staff is not a fast process, and the licence has to exist before it can hold anything.
• Design the change-control strategy at the same time as the submission. What you commit to in an approval determines what counts as a partial change later.
• Resource post-market reporting before approval, because the obligations start immediately and the clocks are measured in days.

A caution on all the figures above. A note on published processing periods, which applies throughout. A standard processing period (標準処理期間) is set under Article 6 of the Administrative Procedure Act. That article obliges an agency to publish the period once it has set one, but setting it is only a best-efforts duty, and there is no statutory obligation to actually meet it. The clock also generally excludes time while an application sits with the applicant for correction.

How far target and outcome diverge is usually invisible, because completion dates are rarely published. In the one area where they are, the gap is substantial: every pesticide re-evaluation concluded to date has taken between 3.5 and 4.0 years against a published period of one year, a finding drawn from MAFF’s own records and set out in our guide to registering a pesticide in Japan. That multiple should not be assumed to apply here. What should be assumed is that a published period is a target, not a commitment, and that planning to it without contingency is optimistic.

Where public affairs comes into it

Most of this is a regulatory affairs exercise, and a good regulatory consultant or in-house RA team will run it. Public affairs matters at the edges, and the edges are where the expensive surprises live: when a classification boundary is genuinely unclear, when a device category sits ahead of the standards that would cover it, when a reimbursement decision determines whether an approved product is viable, and when a rule that shapes your category is still being drafted in an advisory council rather than applied to your file.

Those are questions about how the rules are set, not how to comply with them. If that is where you are, get in touch.

Further reading: PMDA explained covers the agency, the market-entry regulatory checklist maps which institutions apply to your sector, and the policy calendar sets out when the rules themselves are decided.