For FDA approval, a Japanese manufacturer usually needs 510(k) clearance, which FDA decides on your evidence rather than your PMDA approval or certification, and many devices need no 510(k) at all. Every device still needs establishment registration, device listing and a US Agent before it is imported or sold in the US.
Key takeaways
- FDA cleared 249 510(k)s from Japanese applicants from January 2023 to September 2026, the 7th most of any country. Radiology and endoscopy led, and three large groups held 46% of the clearances.
- A PMDA approval does not replace or shorten a 510(k). But Japan is a full member of MDSAP, so one MDSAP audit can serve both Japan and FDA.
- Japanese Traditional 510(k)s took a median of 139 days from receipt to clearance, against 151 days for all applicants. That is about 8% less time than typical for the same device types.
- Endoscopes and imaging systems bring extra FDA expectations: validated reprocessing instructions for reusable devices and cybersecurity documentation for networked software.
- The FY2027 510(k) fee is $28,653, or $7,163 for a small business. A Japanese company qualifies with a certification from its national tax authority.
How many Japanese devices does FDA clear, and which kinds?
We counted every 510(k) that FDA cleared from January 3, 2023 to September 27, 2026, using FDA's public 510(k) data [1]. Applicants in Japan received 249 clearances, 2.1% of all 12,058. Japan ranked 7th by country, behind France (263) and ahead of Switzerland (232).
The count is growing. There were 48 in 2023, 57 in 2024 and 86 in 2025. To the end of September 2026 there were 58, against 63 in the same months of 2025 [1].
The 249 clearances went to 60 companies, but a few dominate. Three large imaging and endoscopy groups held 114 of them (46%) [1].
Japanese clearances are concentrated in a few fields [1]:
| FDA review panel | Japanese clearances | Share |
|---|---|---|
| Radiology | 80 | 32% |
| Gastroenterology and urology | 59 | 24% |
| Cardiovascular | 31 | 12% |
| Dental | 17 | 7% |
| Ophthalmic | 13 | 5% |
| Ear, nose and throat | 13 | 5% |
| All others | 36 | 14% |
These are the most common device types. FDA calls each type a product code [1]:
| Device type (product code) | Japanese clearances |
|---|---|
| CT X-ray systems (JAK) | 15 |
| Catheter guide wires (DQX) | 15 |
| MRI systems (LNH) | 13 |
| Gastroscopes and accessories (FDS) | 10 |
| Diagnostic radiology displays (PGY) | 8 |
| Doppler ultrasound imaging systems (IYN) | 8 |
| Bronchoscopes (EOQ) | 8 |
| Radiological image processing systems (LLZ) | 7 |
Our method: we counted cleared decisions where the applicant's address is in Japan. The applicant is usually the manufacturer. A Japanese company that files through a US subsidiary is counted under the US.
Does a PMDA approval help with FDA clearance?
Not directly. FDA does not accept a PMDA approval or a Japanese certification in place of a 510(k). The 510(k) rules apply to every company that must register with FDA, wherever it is [4]. FDA makes its own decision on your evidence.
What can carry over is the evidence behind your Japanese marketing authorization:
- Test reports. FDA accepts reports from Japanese labs if they meet its expectations, such as testing to the FDA-recognized version of each standard. The section on test reports below covers this.
- Your quality system and audits. Japan's Ministry of Health, Labour and Welfare and PMDA are full members of the Medical Device Single Audit Program, alongside FDA [8]. MDSAP lets one recognized auditing organization run a single audit that meets the requirements of all participating regulators [8]. FDA may accept an MDSAP audit report in place of a routine FDA inspection [8]. Our QMSR guide explains FDA's quality rules.
What does not carry over is your comparison device. A 510(k) must compare your device to a predicate that is legally marketed in the US [4]. A device sold only in Japan cannot be your predicate. For the full picture, see our guide to what a PMDA approval does and does not change.
Does every Japanese device need a 510(k)?
No. Each device type has a classification regulation, and it says whether a 510(k) is needed. Most Class I types and some Class II types are exempt [11].
FDA's registration data shows how often this applies. On October 13, 2026, 533 Japanese sites were registered with FDA. Of the 337 registered as device manufacturers, 138 (41%) list only Class I devices with no 510(k) or PMA number [2]. Among the most common devices Japanese sites list without a 510(k) are non-prescription sunglasses, spectacle frames and non-custom spectacle lenses, all Class I and exempt [2, 11]. Eyeglasses and sunglasses must still have impact-resistant lenses that pass FDA's drop ball test [4].
Two cautions:
- Class I does not always mean exempt. Surgeon's gloves and patient examination gloves are Class I, and they still need a 510(k) [11].
- Exemptions have limits. An exempt device still needs a 510(k) if, for example, it has a different intended use or uses a different fundamental scientific technology from other devices of its type. Each classification part sets out these limits, such as 21 CFR 880.9 for hospital devices [4].
Exempt devices still need establishment registration, device listing and a US Agent before they are imported [4]. Contract manufacturers must register and list too, even when another company owns the design [4]. Japan had 158 sites registered as contract manufacturers [2].
Check your device's product code in FDA's classification database before you plan a 510(k) [11]. Our device classification guide explains how to read an entry.
What do endoscope and imaging makers need to plan for?
Japan's strengths bring two extra FDA expectations.
Reprocessing. About 59 Japanese clearances were endoscopes or endoscopy accessories, such as gastroscopes, bronchoscopes and duodenoscopes [1]. For reusable devices, FDA's guidance explains how to write the reprocessing instructions in your labeling and how to scientifically validate them, covering cleaning, disinfection and sterilization [9]. Plan this validation work early, because it is testing work too.
Cybersecurity. Imaging systems and endoscopy towers often run networked software. FDA's cybersecurity guidance, updated in February 2026, sets out the cybersecurity design, labeling and documentation FDA expects in a premarket submission. It also covers "cyber devices" under section 524B of the FD&C Act [12]. Read it before you freeze the software design, not after.
Radiation rules. About 31 Japanese clearances were X-ray equipment, including CT, or lasers [1]. These are also radiation-emitting electronic products. X-ray systems and many laser products need a radiation safety product report, which must reach FDA before the product enters commerce [4]. A maker of electronic products must also name a permanent US resident, a person or a company, as its agent for legal notices before offering a product for import. This is separate from the US Agent in your registration [4]. MDSAP audits do not replace FDA inspections for these radiation rules [8].
What are the steps from Japan to the US market?
For a device that needs a 510(k), the usual order is:
- Confirm the classification. Find the product code, regulation number and class. If you cannot tell, you can ask FDA through a 513(g) request. Its FY2027 fee is $8,596, or $4,298 for a small business [3].
- Choose a predicate. Pick a device legally marketed in the US with the same intended use. Search FDA's 510(k) database by product code. Our predicate guide explains how.
- Plan and run the testing. Test to the FDA-recognized version of each standard, at a lab in Japan or elsewhere. Include reprocessing validation and cybersecurity work if they apply.
- Request small business status early. If your company and its affiliates had gross receipts of no more than $100 million, apply at least 60 days before the 510(k) fee is due [3].
- Build the submission in eSTAR. FDA has required eSTAR for 510(k)s since October 1, 2023 [5]. All content must be in English, including translated test reports [6].
- Pay the fee and submit. FDA must receive the correct fee when you submit, or it will not accept the 510(k) [3]. FDA then has 15 calendar days for its acceptance review [6].
- Answer FDA's questions. If FDA sends an Additional Information request, the review goes on hold. You have up to 180 calendar days to send a complete response, or FDA considers the 510(k) withdrawn [7].
- Receive the clearance letter. Your device is cleared, not approved. Approval is the word for PMA devices.
- Register, list and name a US Agent. Do this before the device is imported. The sections below cover timing and cost, and our importing guide covers customs entry.
Your team runs the testing through labs of your choice. A US Agent and an importer fill the US roles, and you can add a regulatory advisor.
What does FDA clearance cost a Japanese manufacturer?
FDA's fees for fiscal year 2027 apply from October 1, 2026 to September 30, 2027 [3]:
| FDA fee (FY2027) | Standard | Small business |
|---|---|---|
| 510(k) | $28,653 | $7,163 |
| 513(g) request for classification | $8,596 | $4,298 |
| De Novo request | $191,020 | $47,755 |
| Annual establishment registration | $13,785 | $13,785 |
The small business rate cuts the 510(k) fee by three quarters. To get it, a company outside the US sends FDA a MDUFA Small Business Request form and a certification from its national tax authority. For a Japanese company, that is the National Tax Agency. The certification must show gross receipts for the most recent tax year in both US dollars and yen, the exchange rate used and the dates covered. Each affiliate needs its own certification [3]. If your company belongs to a larger group, the group's receipts count toward the $100 million limit.
Small business status lasts one fiscal year. Status for FY2026 ended on September 30, 2026, so you must qualify again for FY2027 [3]. Our small business guide walks through the request.
The annual registration fee has no small business rate. FDA may waive it only for a business with no more than $1 million in gross receipts on its most recent US federal tax return [3].
FDA fees are only part of the budget. The real cost drivers are:
- Testing. Its scope depends on your device type and predicate. Reprocessing validation and cybersecurity work can be large items for endoscopes and imaging systems.
- Translation. Every report and supporting document must be in English [6].
- Repeat work. Tests to the wrong standard version, or a weak response to FDA's questions, add cost and time.
- US roles. You will pay a US Agent, and you may pay an advisor.
Use our FDA user fees page to check the current rates before you budget.
How long does FDA clearance take for Japanese manufacturers?
Japanese Traditional 510(k)s cleared from January 2023 to September 2026 took a median of 139 days from FDA's receipt to clearance. A quarter cleared within 90 days, and a quarter took 238 days or more [1]. The median for all applicants was 151 days.
Japan is one of the faster countries. Compared with the median for the same device types, Japanese 510(k)s took about 8% less time [1]. The median improved from 193.5 days in 2023 to 142 in 2024 and 121 in 2025, then 144.5 so far in 2026 [1]. Our review times by country analysis has the full method.
Device type still matters [1]:
| Device type (product code) | Japanese 510(k)s | Japanese median (days) | All applicants median (days) |
|---|---|---|---|
| Endoscopic video imaging systems (FET) | 5 | 80 | 145 |
| Doppler ultrasound imaging systems (IYN) | 8 | 109.5 | 121 |
| MRI systems (LNH) | 13 | 124 | 129 |
| Catheter guide wires (DQX) | 6 | 142.5 | 201 |
| CT X-ray systems (JAK) | 13 | 146 | 149 |
| Bronchoscopes (EOQ) | 8 | 216 | 169 |
| Gastroscopes and accessories (FDS) | 8 | 220 | 210.5 |
| Interventional fluoroscopic X-ray systems (OWB) | 5 | 265 | 174 |
The all-applicant figures include the Japanese clearances. Most counts per device type are small, so treat them as a signal, not a forecast.
FDA's review goal counts only FDA's own days. Its clock stops while it waits for your answers, and it starts only once FDA accepts the file [7]. So much of a long total is time on hold.
Japanese companies also use the other 510(k) types. Special 510(k)s, for changes to your own cleared device, took a median of 47 days across 25 Japanese clearances. Japan had 13 Abbreviated 510(k)s, 5% of its clearances, against about 1% for all applicants [1]. Only 5 Japanese clearances used third-party review [1]. Our third-party review guide explains which device types are eligible.
When do you need a US Agent and FDA registration?
Not before your 510(k). You can submit a 510(k) and receive clearance before you register. But no device may be imported into the US unless its maker's site is registered and the device is listed [4].
The rules for a Japanese site [4]:
- Timing. Register within 30 days of starting the operation that requires registration, and list your devices at the same time.
- Fee first. Pay the annual registration fee before you register. A site is not legally registered until it has registered and paid [3].
- One US Agent. Name one US Agent who lives or has a place of business in the US. FDA may contact the agent when it cannot reach you, and the agent helps schedule inspections. Report any change to the agent within 10 business days.
- Every year. Renew registration and review all listings between October 1 and December 31.
- English. Registration and listing information must be in English.
Complizen's US team handles establishment registration, device listing and the US Agent role for foreign manufacturers. Exempt devices can enter the US this way while a 510(k) for another device is still in progress.
Which Japanese test reports does FDA accept?
FDA accepts test reports from Japanese labs. What counts is the standard and version you tested to, the completeness of the report and how the study was run, not where the lab is.
Three points matter most for Japanese manufacturers:
- Seven ASCA labs in Japan. On October 12, 2026, FDA's ASCA program listed seven accredited labs in Japan, run by UL Japan, Intertek Japan, CSA Group Japan and TÜV SÜD Japan. All seven are accredited for basic safety and essential performance testing [10]. None covers biocompatibility.
- JIS versions. If your lab tested to a Japanese Industrial Standard, check that it matches the FDA-recognized version of the corresponding international standard. FDA's Recognized Consensus Standards database lists each recognized version.
- Translations. Translate every report into English, including the test method and results [6].
Our guide to using foreign test reports in a 510(k) covers the full rules, including biocompatibility and Good Laboratory Practice.
What do Japanese manufacturers get wrong?
Each of these mistakes breaks a clear FDA rule:
| Common mistake | What FDA actually requires |
|---|---|
| Sending the Japanese application file as the 510(k) | A comparison to a US predicate, in the eSTAR format, in English [4, 5, 6] |
| Choosing a predicate sold only in Japan | A predicate legally marketed in the US [4] |
| Leaving reprocessing validation to the end | Validated reprocessing instructions for reusable devices, as FDA's guidance recommends [9] |
| Treating cybersecurity as a software afterthought | Cybersecurity design and documentation in the premarket submission [12] |
| Forgetting the radiation rules for X-ray and CT | A product report before sale, and an agent for legal notices before import [4] |
| Paying the full 510(k) fee by mistake | A small business request, with a National Tax Agency certification, at least 60 days before the fee is due [3] |
| Answering an FDA question late or in part | A complete response within 180 calendar days, or the 510(k) is withdrawn [7] |
What should you do next?
Start with your product code. It tells you whether you need a 510(k), which standards apply and how long similar devices have taken. Then compare your Japanese application file with what a 510(k) for that product code needs. Before you submit, decide who will answer FDA's questions in English, and how fast.
If you want a second view of that comparison, Complizen's free Gap Assessment checks your device documents against what a 510(k) needs before you file. For the wider picture of selling in the US from outside it, see our international path.
Frequently asked questions
How does a Japanese manufacturer get FDA approval?
Most devices from Japan need 510(k) clearance, not approval. You show that your device is substantially equivalent to a predicate legally marketed in the US. Some devices are exempt from a 510(k). Every device also needs FDA establishment registration, device listing and a US Agent before it is imported.
Does a PMDA approval speed up FDA clearance?
No. FDA does not accept a PMDA approval in place of a 510(k), and it does not shorten FDA's review. What can carry over is the evidence behind it, such as test reports to FDA-recognized standards. Japan's full MDSAP membership also means one MDSAP audit can serve both regulators.
How many Japanese medical devices has FDA cleared?
FDA cleared 249 510(k)s from applicants in Japan from January 2023 to September 2026, according to our count of FDA's public data. That is the 7th most of any country. Radiology and gastroenterology devices led, and three large groups held 46% of the clearances.
Can one MDSAP audit cover Japan and the US?
Yes, that is the purpose of MDSAP. Japan's MHLW and PMDA and the US FDA are all full members. A recognized auditing organization runs one audit against the requirements of the participating regulators. FDA may accept the report in place of a routine inspection, though not for radiation product rules.
Do I need a US Agent before submitting a 510(k)?
No. You can submit a 510(k) and receive clearance before naming a US Agent. You must register your site, list the device and name a US Agent before the device is imported into the US. Registration also requires paying the annual registration fee first.
How much does a 510(k) cost a Japanese company in FY2027?
FDA's 510(k) fee for fiscal year 2027 is $28,653, or $7,163 for a qualifying small business. Annual establishment registration is $13,785. Testing, translation, a US Agent and any advisor are separate costs. Reprocessing validation and cybersecurity work can add to testing for some devices.
How does a Japanese company qualify as an FDA small business?
Send FDA a MDUFA Small Business Request form and a certification from Japan's National Tax Agency. It must show gross receipts in US dollars and yen, with the exchange rate. Affiliates need certifications too, and combined receipts must be no more than $100 million. Apply at least 60 days before the fee is due.
How long does FDA clearance take for Japanese manufacturers?
Japanese Traditional 510(k)s cleared from 2023 to September 2026 took a median of 139 days from receipt to clearance, against 151 days for all applicants. That is about 8% faster than typical for the same device types. The median improved from 193.5 days in 2023 to 121 in 2025.
Can I use test reports from a Japanese lab?
Yes. FDA accepts reports from Japanese labs if they meet its expectations: the FDA-recognized standard version, a complete report and an English translation. Seven Japanese labs are in FDA's ASCA program for basic safety and essential performance. If a test used a JIS, check it matches the recognized version.
Do endoscopes need reprocessing validation for a 510(k)?
FDA's guidance explains how to write reprocessing instructions for reusable devices such as endoscopes, and how to scientifically validate them. In practice that means cleaning, disinfection or sterilization testing on your device. Plan it early, because it is testing work that needs time in the schedule.
Can I use a device sold in Japan as my predicate?
No. A predicate must be legally marketed in the US. That means a device cleared through a 510(k), marketed before May 28, 1976, or reclassified. You can search FDA's 510(k) database by product code to find predicates that companies with similar devices have used.
What extra rules apply to X-ray and CT systems?
X-ray and CT systems are also radiation-emitting electronic products. They need a radiation safety product report before they enter commerce. The maker must also name a permanent US resident as its agent for legal notices before import. This is separate from the US Agent named in registration.
References
- openFDA. 510(k) API, decisions dated January 3, 2023 to September 27, 2026. Accessed October 12, 2026.
- openFDA. Registration and Listing API, establishments in Japan. Accessed October 13, 2026.
- FDA. Medical Device User Fee Rates for Fiscal Year 2027. Federal Register, July 30, 2026.
- eCFR. Title 21: Part 807, Establishment Registration and Device Listing (§§ 807.20, 807.22, 807.40, 807.81, 807.92); § 801.410, Impact-resistant lenses in eyeglasses and sunglasses; § 880.9, Limitations of exemptions; § 1002.10, Product reports; § 1005.25, Service of process on manufacturers. Current as of October 2026.
- FDA. Electronic Submission Template for Medical Device 510(k) Submissions. Final guidance, October 2, 2023.
- FDA. Refuse to Accept Policy for 510(k)s. Final guidance, April 21, 2022.
- FDA. FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. Final guidance, October 3, 2022.
- FDA. Medical Device Single Audit Program (MDSAP). Content current as of December 19, 2025.
- FDA. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Final guidance, March 2015, content current as of June 13, 2018.
- FDA. ASCA-Accredited Testing Laboratories database. Accessed October 12, 2026.
- FDA. Product Classification database. Accessed October 13, 2026.
- FDA. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. Final guidance, February 2026.