For FDA approval, a Taiwanese manufacturer usually needs 510(k) clearance, which FDA decides on your evidence rather than your TFDA licence, and many devices, including most eyewear, 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 213 510(k)s from Taiwanese applicants from January 2023 to September 2026, the 10th most of any country. Taiwan had 23 of the 42 clearances for daily wear soft contact lenses.
- A TFDA licence does not replace or shorten a 510(k). Your test reports and quality system can carry over. The licence itself does not.
- Of 492 Taiwanese sites registered with FDA as device manufacturers, 217 list only Class I devices with no 510(k). Sunglasses, spectacle frames and lenses are exempt, but they must still meet FDA's impact rule.
- Taiwanese Traditional 510(k)s took a median of 234 days from receipt to clearance, about 21% longer than typical for the same device types. Special 510(k)s took a median of 30 days.
- The FY2027 510(k) fee is $28,653, or $7,163 for a small business. A Taiwanese company qualifies with a certification from its national tax authority.
How many Taiwanese 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 Taiwan received 213 clearances, 1.8% of all 12,058. Taiwan ranked 10th by country, just behind the UK (215) and ahead of Canada (198).
The 213 clearances went to 116 companies. The yearly count rose from 44 in 2023 to 63 in 2024 and 66 in 2025. There were 40 to the end of September 2026, against 54 in the same months of 2025 [1].
Taiwanese clearances are spread across many fields [1]:
| FDA review panel | Taiwanese clearances | Share |
|---|---|---|
| Radiology | 32 | 15% |
| General and plastic surgery | 26 | 12% |
| Orthopedic | 24 | 11% |
| Neurology | 24 | 11% |
| Ophthalmic | 23 | 11% |
| Cardiovascular | 16 | 8% |
| Anesthesiology | 14 | 7% |
| All others | 54 | 25% |
These are the most common device types. FDA calls each type a product code [1]:
| Device type (product code) | Taiwanese clearances |
|---|---|
| Daily wear soft contact lenses (LPL) | 23 |
| Orthopedic stereotaxic instruments (OLO) | 10 |
| Over-the-counter TENS nerve stimulators (NUH) | 7 |
| Electrosurgical cutting and coagulation devices (GEI) | 6 |
| Bone fixation plates (HRS) | 5 |
| Laparoscopes (GCJ) | 5 |
| Radiotherapy image processing software (QKB) | 5 |
| Radiological triage and notification software (QAS) | 5 |
Software is a notable part of the mix. 18 Taiwanese clearances were for radiology or digital pathology software. Our AI device tracker covers AI-enabled devices across all countries.
Our method: we counted cleared decisions where the applicant's address is in Taiwan. The applicant is usually the manufacturer. A Taiwanese company that files through a US subsidiary is counted under the US.
Does a TFDA licence help with FDA clearance?
Not directly. FDA does not accept a TFDA licence 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 licence:
- Test reports. FDA accepts reports from Taiwanese 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. FDA's Quality Management System Regulation took effect on February 2, 2026. It incorporates ISO 13485:2016 by reference [9]. A working ISO 13485 system is a strong base. But FDA says it will not accept an ISO 13485 certificate as a substitute for its own oversight, including inspections [9].
- MDSAP audits. TFDA is an Affiliate Member of the Medical Device Single Audit Program [8]. That status does not change your 510(k). But FDA may accept an MDSAP audit report in place of a routine FDA inspection [8].
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 Taiwan cannot be your predicate. For the full picture, see our guide to what a TFDA licence does and does not change.
Does every Taiwanese device need a 510(k)?
No. This is a common misconception. 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, 624 Taiwanese sites were registered with FDA. Of the 492 registered as device manufacturers, 217 (44%) list only Class I devices with no 510(k) or PMA number [2]. The most common devices Taiwanese sites list without a 510(k) are eyewear: non-prescription sunglasses, magnifying spectacles, spectacle frames, eye shields and spectacle lenses. All of these are Class I and exempt [2, 11].
Exempt eyewear still has a rule to meet. Eyeglasses and sunglasses sold in the US must have impact-resistant lenses. FDA's reference test drops a 5/8-inch steel ball from 50 inches onto the lens, and the lens must not fracture [4]. An importer can have the tests done in the country of origin, such as Taiwan, but must give FDA the results on request [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]. Taiwan had 230 sites registered as contract manufacturers, and 213 registered as exporters that do no other work on the device [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 contact lens makers need to know?
Taiwan is the largest source of daily wear soft contact lens clearances. It had 23 of the 42 cleared from January 2023 to September 2026, ahead of the US with 13 [1].
The wear schedule decides the pathway. A soft contact lens for daily wear only is Class II and needs a 510(k). A soft contact lens for extended wear is Class III and needs PMA approval [4]. So adding an extended wear claim changes the whole project, not just the label.
Taiwanese daily wear lens 510(k)s took a median of 167 days to clear, against 182 days for all applicants [1]. The product code is eligible for third-party review [11], yet only one Taiwanese clearance of any kind used it in the period [1]. Our third-party review guide explains how the route works.
What are the steps from Taiwan 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 Taiwan or elsewhere.
- 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 Taiwanese 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 Taiwanese company, that is the Ministry of Finance's taxation office. The certification must show gross receipts for the most recent tax year in both US dollars and New Taiwan dollars, the exchange rate used and the dates covered. Each affiliate needs its own certification [3].
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.
- 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 Taiwanese manufacturers?
Taiwanese Traditional 510(k)s cleared from January 2023 to September 2026 took a median of 234 days from FDA's receipt to clearance. A quarter cleared within 128 days, and a quarter took 268 days or more. Only 16% cleared within 90 days [1]. The median for all applicants was 151 days.
The device mix explains only part of the gap. Compared with the median for the same device types, Taiwanese 510(k)s took about 21% longer [1]. Our review times by country analysis has the full method, and our Taiwan timeline guide covers where the time goes.
Device type still matters [1]:
| Device type (product code) | Taiwanese 510(k)s | Taiwanese median (days) | All applicants median (days) |
|---|---|---|---|
| Bone fixation plates (HRS) | 5 | 91 | 98 |
| Laparoscopes (GCJ) | 5 | 121 | 118 |
| Radiological triage software (QAS) | 5 | 158 | 110 |
| Daily wear soft contact lenses (LPL) | 21 | 167 | 182 |
| Non-invasive blood pressure systems (DXN) | 5 | 181 | 175 |
| Over-the-counter TENS stimulators (NUH) | 5 | 197 | 126 |
| Electrosurgical devices (GEI) | 6 | 253.5 | 140 |
The all-applicant figures include the Taiwanese clearances. Most Taiwanese 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. That puts the fastest lever in your hands: a complete eSTAR and quick, complete answers to FDA's questions.
Special 510(k)s, for changes to your own cleared device, took a median of 30 days. Taiwanese companies used them for 26 of 213 clearances (12%) [1].
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 Taiwanese 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.
X-ray and laser devices have extra rules. Ten Taiwanese clearances were X-ray equipment 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 a separate designation from the US Agent in your registration [4].
Complizen's US team handles establishment registration, device listing and the US Agent role for foreign manufacturers. Exempt devices, such as eyewear, can enter the US this way while a 510(k) for another device is still in progress.
Which Taiwanese test reports does FDA accept?
FDA accepts test reports from Taiwanese 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 Taiwanese manufacturers:
- Five ASCA labs in Taiwan. On October 12, 2026, FDA's ASCA program listed five accredited labs in Taiwan: Underwriters Laboratories Taiwan, TÜV Rheinland Taiwan, MedTech Testing Solution, and Eurofins E&E Wireless Taiwan at two sites. All five are accredited for basic safety and essential performance testing [10]. None covers biocompatibility.
- Lab accreditation is not GLP. For biocompatibility, FDA recommends complete test reports and a statement that the studies followed its Good Laboratory Practice rules in 21 CFR Part 58 [12]. ISO/IEC 17025 accreditation, from TAF or any other body, does not answer that. FDA notes it does not recognize ISO/IEC 17025 for this purpose [12].
- 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.
What do Taiwanese manufacturers get wrong?
Each of these mistakes breaks a clear FDA rule:
| Common mistake | What FDA actually requires |
|---|---|
| Sending the TFDA technical 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 Taiwan | A predicate legally marketed in the US [4] |
| Assuming exempt eyewear has no rules | Impact-resistant lenses, with test results available to FDA [4] |
| Adding an extended wear claim to a soft contact lens | PMA approval, because extended wear soft lenses are Class III [4] |
| Paying the full 510(k) fee by mistake | A small business request, with a tax authority certification, at least 60 days before the fee is due [3] |
| Treating TAF accreditation as GLP | A GLP statement for biocompatibility studies [12] |
| 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 TFDA 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. Holds are where much of the time goes.
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 Taiwanese manufacturer get FDA approval?
Most devices from Taiwan need 510(k) clearance, not approval. You show that your device is substantially equivalent to a predicate legally marketed in the US. Some devices, such as most eyewear, are exempt from a 510(k). Every device also needs FDA establishment registration, device listing and a US Agent before import.
Does a TFDA licence speed up FDA clearance?
No. FDA does not accept a TFDA licence in place of a 510(k), and it does not shorten FDA's review. What can carry over is the evidence behind the licence, such as test reports to FDA-recognized standards and an ISO 13485 quality system. FDA judges that evidence on its own terms.
How many Taiwanese medical devices has FDA cleared?
FDA cleared 213 510(k)s from applicants in Taiwan from January 2023 to September 2026, according to our count of FDA's public data. That is the 10th most of any country. Radiology, surgery, orthopedic, neurology and ophthalmic devices led, and 23 clearances were daily wear soft contact lenses.
Do sunglasses and eyeglass frames need FDA clearance?
No 510(k) is needed. Non-prescription sunglasses, spectacle frames and non-custom spectacle lenses are Class I and exempt. The maker must still register, list the devices and name a US Agent before import. Eyeglass and sunglass lenses must also be impact-resistant and pass FDA's drop ball test.
Do contact lenses need a 510(k) or PMA?
It depends on the wear schedule. A soft contact lens for daily wear only is Class II and needs a 510(k). A soft contact lens for extended wear is Class III and needs PMA approval. Taiwan had 23 of the 42 daily wear soft lens clearances from 2023 to September 2026.
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 Taiwanese 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. They depend on your device type and how much testing your predicate comparison needs.
How does a Taiwanese company qualify as an FDA small business?
Send FDA a MDUFA Small Business Request form and a certification from Taiwan's national tax authority. It must show gross receipts in US dollars and New Taiwan dollars, with the exchange rate. Affiliates need certifications too. 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 Taiwanese manufacturers?
Taiwanese Traditional 510(k)s cleared from 2023 to September 2026 took a median of 234 days from receipt to clearance. That is about 21% longer than typical for the same device types, and only 16% cleared within 90 days. Much of the time is hold time while FDA waits for answers.
Can I use test reports from a Taiwanese lab?
Yes. FDA accepts reports from Taiwanese labs if they meet its expectations: the FDA-recognized standard version, a complete report and an English translation. Five Taiwanese labs are in FDA's ASCA program for basic safety and essential performance. Biocompatibility studies also need a statement on Good Laboratory Practice.
Can I use a device sold in Taiwan 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 laser devices?
X-ray and laser devices are also radiation-emitting electronic products. X-ray systems and many lasers 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 Taiwan. 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; § 886.5925, Soft (hydrophilic) contact lens; § 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. Medical Devices; Quality System Regulation Amendments. Final rule, Federal Register, February 2, 2024, effective February 2, 2026.
- FDA. ASCA-Accredited Testing Laboratories database. Accessed October 12, 2026.
- FDA. Product Classification database. Accessed October 13, 2026.
- FDA. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Final guidance, September 8, 2023.