Do You Need a Licence to Ship Medical Devices to Taiwan? Licence-Free Quantities and Classes at a Glance
- Licence-free import: Items exclusively for personal use that fall within the items and quantities listed in the schedule to the Regulations on Special Approval for Manufacture and Import of Certain Medical Devices may be imported through the expedited customs clearance channel (Article 6(4)(1) of the Regulations).
- Once per six months: Imports through the expedited customs clearance channel (postal/express shipments) are limited to once per six months—but the provision expressly states "**except for inbound travellers carrying items themselves**", so items you bring back in person are not subject to this frequency limit (Article 6(5)).
- Common limits: 60 daily disposable contact lenses of a single prescription (limited to a single brand and up to 2 prescriptions), 250 medical masks, 60 condoms, 120 tampons, and 200 cotton swabs.
- Tax is not the main issue: Tariffs are generally 0% for blood pressure monitors, thermometers, and blood glucose meters; about 5% for contact lenses and condoms; and 7.5% for medical masks. Postal/express shipments with a customs value ≤ NT$2,000 are tax-exempt (not applicable once you exceed 6 duty-free releases in a half-year); items carried by inbound travellers are subject to a separate duty-free allowance under the Regulations Governing Inspection, Duty Levy and Release of Baggage of Inbound Passengers.
- The consequence of exceeding a limit depends on intent to sell: Criminal liability (imprisonment for up to 3 years and a fine of up to NT$10,000,000 under Article 62 of the Medical Devices Act) requires "**intent to sell or supply**". Even for purely personal use, however, importing medical devices outside the schedule without approval may lead customs to withhold release or return the goods, and an administrative fine of NT$60,000–2,000,000 may be imposed under Article 68(1)(5) of the same Act; travellers who conceal items and fail to declare them also risk confiscation under the Customs Anti-Smuggling Act.
- Blood pressure monitors, body fat scales, blood glucose meters, and other devices outside the schedule: to bring them to Taiwan, you must first apply to the TFDA for personal-use special approval (fee NT$2,000; a medical certificate or prescription is required; for instruments, 1 unit per model; the TFDA decides case by case). The widely circulated claim that "1 unit for personal use needs no application" mistakes the application quantity cap for an exemption.
Sources: Medical Devices Act; Regulations on Special Approval for Manufacture and Import of Certain Medical Devices; Taiwan Food and Drug Administration, Ministry of Health and Welfare; Customs Administration, Ministry of Finance
Last updated: 2026-09-15 (added direct answers on travellers bringing blood pressure monitors and body fat scales, the personal-use special approval application process (including the Article 68 administrative fine), and HowBridge core data; legal references and elements of criminal liability reviewed on 2026-07-30)
Licence-Free Import List and Quantities
Only the 8 schedule items can be imported licence-free; blood pressure monitors and other devices require special approval first. The Medical Devices Act Article 25(1) requires medical devices to be registered and a licence obtained before import; however, Article 35 authorises the competent authority to grant special approval in specified circumstances, without being bound by Article 25(1). Licence-free import for personal use is based on this authority and provided for in Article 6(4)(1) of the Regulations on Special Approval for Manufacture and Import of Certain Medical Devices: items exclusively for personal use that fall within the items and quantities listed in the schedule may be imported through the expedited customs clearance channel.
| Medical Device | Maximum Quantity for Licence-Free Import |
|---|---|
| Daily disposable contact lenses | 60 lenses of a single prescription (limited to a single brand and up to 2 prescriptions) |
| Corrective lenses | 1 pair |
| Medical masks | 250 pieces/masks |
| Condoms | 60 pieces |
| Tampons | 120 pieces |
| Adhesive bandages | 60 pieces/bandages |
| Liquid bandages | 4 tubes/cans/bottles/applicators |
| Cotton swabs | 200 swabs |
Note: Medical devices exceeding the quantities above, or devices not included in the schedule (such as blood pressure monitors, blood glucose meters, and thermometers), do not qualify for licence-free import. They must undergo registration and inspection or obtain separate special approval for import in accordance with the applicable requirements. Refer to the competent authority's latest announcements for the current scheduled items and quantities.
Can I bring a blood pressure monitor bought in Japan to Taiwan?
Yes, but you must apply first, and approval is not guaranteed. Blood pressure monitors are Class II medical devices and are not among the 8 application-free items in the schedule to the Regulations on Special Approval for Manufacture and Import of Certain Medical Devices. You must first apply to the TFDA for "personal-use special approval" (fee NT$2,000, non-refundable once the application is accepted; attach a medical certificate or prescription stating the condition, the device name, and the quantity and specifications; for instruments, 1 unit per model; the TFDA approves or rejects based on the reasons given), and declare the device to customs on arrival once you have the approval letter. The "once per six months" rule applies only to expedited clearance of the 8 schedule items and has nothing to do with special approval for blood pressure monitors. If you bring one in without an approval letter, customs may require supplementary documents or order the item returned, and an administrative fine of NT$60,000–2,000,000 may be imposed under Article 68(1)(5) of the Medical Devices Act.
"1 unit for personal use needs no application" is a misunderstanding
A common online claim mixes up two things: Article 7(3) of the Regulations—"instruments exclusively for personal use are limited to one unit per model"—is the quantity cap for a special approval application, not an exemption from applying. The only application-free items are the 8 in the schedule (adhesive bandages, liquid bandages, cotton swabs, condoms, tampons, daily disposable contact lenses, corrective lenses, and medical masks). The entry guidance updated by Taipei Customs, Customs Administration, Ministry of Finance, on 2025-06-24 states this clearly: medical devices outside the schedule require an import licence issued by the TFDA (for individuals, this means special approval under Article 35) and must be declared to customs on entry.
Body fat scales, blood glucose meters, and low-frequency therapy devices are also medical devices—can I bring them to Taiwan?
The same rules apply. Body fat scales that measure body fat percentage, visceral fat, and similar metrics, as well as blood glucose meters, ear thermometers, and low-frequency therapy devices, are all Class II medical devices and are not among the 8 schedule items, so you must also obtain personal-use special approval before bringing them to Taiwan. Electronic scales that measure only body weight, not body fat, are not medical devices and can be carried freely (tariff heading 8423.10, personal weighing machines, 3.4% tariff). Blood glucose test strips and lancets are consumables; the special approval quantity is limited to a 6-month supply (Article 7(2)), and your usage estimate must be stated in the undertaking.
How do I apply for personal-use special approval? What does it cost, and which documents are required?
Apply by post to the TFDA Division of Medical Devices and Cosmetics (Building F, No. 109, Lane 130, Section 1, Academia Road, Nangang District, Taipei City). The fee is NT$2,000 (by postal money order or sight cheque payable to "Food and Drug Administration, Ministry of Health and Welfare" (衛生福利部食品藥物管理署)). The application must be filed by a single natural person because of their specific medical needs, with the following 5 documents:
- Application form (signed or sealed)
- Proof of identity
- Instructions for use of the medical device (if not in Traditional Chinese or English, attach a Traditional Chinese or English translation)
- Personal-use undertaking (with a detailed usage estimate)
- A medical certificate or prescription issued by a medical institution in Taiwan or abroad (stating the condition requiring the device, the device name, quantity and specifications, and noting that it "can be operated by the patient themselves")
Quantity caps: 1 unit per model for instruments (except in special circumstances such as use at different locations) and a 6-month supply for consumables (Article 7(2) and (3) of the Regulations). Incomplete documents may be supplemented once; if the deadline is missed or the supplement is still incomplete, the TFDA may reject the application outright (Article 6(3)). Once the application has been accepted and you have been notified to supplement documents or the review is complete, the fee is not refunded. The TFDA decides based on the reasons for the application, the benefits and risks, and the quantity (Article 20). Enquiry line: (02)8170-6008.
Carrying in person, postal shipping, or consolidated shipping—what is the difference?
| Import method | Within the 8 schedule items (contact lenses, masks, condoms…) | Outside the schedule (blood pressure monitors, body fat scales, blood glucose meters…) | "Once per six months" limit (applies only to expedited clearance of the 8 schedule items) |
|---|---|---|---|
| Carried by inbound travellers | No application needed within the quantities; simply declare truthfully | Obtain TFDA personal-use special approval first and declare to customs on entry | Not limited (exception in Article 6(5)) |
| Overseas online orders by post (EMS/parcel post) | Expedited clearance without application if within the quantities | Special approval required first; otherwise release is refused | 8 schedule items limited to once per six months; items outside the schedule go through special approval, with quantities per the approval letter |
| Express/consolidated shipping (including HowBridge) | Same as above; truthfully declare the product name and quantity before the goods enter the warehouse | Same as above; obtain the approval letter before shipping to the consolidation warehouse | 8 schedule items: postal and express shipments combined are limited to once per six months; items outside the schedule same as left |
※ All three methods are for personal use only and may not be resold (TFDA press release, 2025-06-25). The simplest way to avoid a special approval application is to buy a model in Taiwan that already holds a medical device licence—Japanese versions of the same model usually have no Taiwan licence, and the manufacturer's Taiwan branch often does not provide warranty service for them.
HowBridge core data (free to cite)
- Of the 12,699 11-digit tariff lines in our tariff database, 137 carry import regulation code 504 (medical devices for human use; a TFDA licence or consent document is required).
- Of these 137 medical device lines, 108 (78.8%) have a 0% tariff and 18 have a 5% tariff; Chapter 90 (optical and medical instruments) accounts for 93 (67.9%), Chapter 30 for 18, and Chapter 40 for 7.
- Blood pressure monitors fall under tariff heading 9018.90.10 (including 11-digit line 9018.90.10.90.2, "other sphygmomanometers"), with a 0% tariff and import regulation 504; thermometers (9025.19.90.10.1) and blood glucose meters (9027.89.80.10.6) are also 0% + 504.
- The personal-use application-free schedule has only 8 items (current version of 110-04-22, i.e. 2021-04-22; the TFDA press release of 2025-06-25 lists the same items again). Blood pressure monitors, body fat scales, and blood glucose meters are not included.
- Personal-use special approval: fee NT$2,000, 5 required documents, 1 unit per model for instruments, and a 6-month supply for consumables (Article 7 of the Regulations).
- HowBridge sea express NT$50/unit and air freight NT$100/kg (rates used by the calculator on this page; the official website announcement prevails). Customs value ≤ NT$2,000 is tax-exempt; the exemption does not apply once you exceed 6 duty-free releases in a half-year.
※ Tariff statistics are from a query of our tariff database on 2026-09-15; legal figures are from the Laws & Regulations Database of the Republic of China and publicly available TFDA information.
Terms used on this page
- Special approval for certain medical devices (personal use)
- Under Article 35 of the Medical Devices Act and the Regulations on Special Approval for Manufacture and Import of Certain Medical Devices, an import approval that an individual applies for from the TFDA for personal use, without being bound by the licence requirement of Article 25(1). The fee is NT$2,000; 1 unit per model for instruments and a 6-month supply for consumables. The TFDA decides based on the reasons given—submitting an application does not guarantee approval.
- Expedited clearance (licence-free import of schedule items)
- Article 6(4)(1) of the Regulations: items exclusively for personal use that match the 8 schedule items and quantities may be imported without applying for special approval. Postal and express shipments are limited to once per six months; items carried in by inbound travellers are not subject to this frequency limit.
- Medical device classes (Class I, Class II, Class III)
- Three classes from low to high risk: Class I includes adhesive bandages and medical masks; Class II includes blood pressure monitors, body fat scales, blood glucose meters, and contact lenses; Class III covers high-risk devices such as implants. The class determines the registration and licence requirements, which is a separate question from whether an item is on the application-free schedule.
Official sources for this section：Regulations on Special Approval for Manufacture and Import of Certain Medical Devices (including schedule) ｜ Taipei Customs, Customs Administration: entry clearance guidance "Drugs and Medical Devices" (2025-06-24) ｜ TFDA: special approval for manufacture or import of medical devices ｜ TFDA press release 2025-06-25: food, drugs, medical devices and cosmetics brought in by travellers are for personal use only
Correct Scope of "Once per Six Months"
Article 6(5) of the Regulations on Special Approval for Manufacture and Import of Certain Medical Devices provides that, in the circumstances under Article 6(4)(1), imports through the expedited customs clearance channel are limited to once per six months, except for inbound travellers carrying items themselves.
Subject to the "Once per Six Months" Limit
- Purchases made online overseas and sent back to Taiwan by post
- Imports through expedited customs clearance channels such as express delivery/consolidated shipping
Not Subject to This Limit
- Inbound travellers carrying items themselves (items brought back personally from overseas are expressly exempt under the provision)
- Imports for which a licence or special approval has been obtained in accordance with applicable requirements
※ In other words, postal and express shipments combined may use the licence-free allowance only once during the same six-month period; items personally brought back from overseas are counted separately. The items must still fall within the scheduled items and quantities and must be declared truthfully.
Medical Device Classes (What Counts as a Medical Device)
| Class | Risk | Common Items |
|---|---|---|
| Class 1 | Low | Stethoscopes, adhesive bandages, medical masks, gauze, elastic bandages, tongue depressors, and manual wheelchairs |
| Class 2 | Moderate | Daily-wear/daily disposable contact lenses, blood glucose meters, blood pressure monitors, thermometers, ear thermometers, tampons, condoms, body fat scales, and low-frequency therapy devices |
| Class 3 | High | Implantable medical devices and similar products (generally ineligible for personal-use import) |
※ Many products commonly considered everyday goods are actually medical devices (including blood pressure monitors, thermometers, contact lenses, and condoms). Their import is regulated, and they cannot be shipped in bulk as ordinary goods.
Tested Landed Costs and Tariff Codes
The following results were tested using this site's tariff engine (sea shipping). Click a tariff number to open its CCC tariff page and view the full tariff rate and import requirements:
| Medical Device Click to Add to the Calculator | Product Price | CCC Tariff Number | Tariff Rate | Customs Value | Import Tax |
|---|---|---|---|---|---|
| Daily disposable contact lensesClick to Add to the Calculator | ¥3,000 | 9001.30.00.00.5 | 5% | NT$591 | Tax-exempt |
| Electronic blood pressure monitorClick to Add to the Calculator | ¥5,000 | 9018.90.10.10.9 | 0% | NT$985 | Tax-exempt |
| Ear thermometer/thermometerClick to Add to the Calculator | ¥3,000 | 9025.19.90.10.1 | 0% | NT$591 | Tax-exempt |
| Blood glucose meterClick to Add to the Calculator | US$40 | 9027.89.80.10.6 | 0% | NT$1,260 | Tax-exempt |
| CondomsClick to Add to the Calculator | ¥1,500 | 4014.10.00.10.2 | 5% | NT$296 | Tax-exempt |
| Medical masksClick to Add to the Calculator | ¥1,000 | 6307.90.50.31.1 | 7.5% | NT$197 | Tax-exempt |
※ Tariffs on medical devices are generally 0% (blood pressure monitors, thermometers, and blood glucose meters); rates are about 5% for contact lenses and condoms and about 7.5% for medical masks. A customs value ≤ NT$2,000 is tax-exempt, so most individual items are exempt. The real restrictions are quantity and classification requirements, not tax.
Legal Consequences of Exceeding the Limits
⛔ Intent to Sell or Supply: Criminal Liability
The elements of the offence under Article 62(1) of the Medical Devices Act require a person, "with intent to sell or supply," to violate Article 25(1) by manufacturing or importing medical devices without approval. The offence is punishable by imprisonment for up to 3 years, short-term imprisonment, and/or a fine of up to 10 million New Taiwan dollars (NT$10,000,000). Article 62(2) imposes the same penalty on a person who knowingly sells, supplies, transports, stores, brokers, transfers, or displays with intent to sell the medical devices described in the preceding paragraph. Bulk proxy purchasing and resale of medical devices are commercial activities within this scope.
Excess Quantities for Personal Use: Primarily Denied Clearance
Where there is no intent to sell or supply, merely exceeding the scheduled quantity for personal use or shipping an item not listed in the schedule generally does not constitute the criminal offence under Article 62. Instead, the import fails to qualify for licence-free import—the goods may be held pending supplemental documentation, returned, or otherwise handled in accordance with applicable regulations, and the importer must separately complete registration and inspection or apply for special approval to import. Customs and the competent authority will determine the actual disposition based on the individual case.
💡 Practical advice: Keep quantities within the schedule, send everything in a single shipment (because postal/express shipments have only one allowance per six months), and truthfully declare the product name and quantity. Contact lenses most commonly exceed the limit, so remember: a single brand, 60 lenses of a single prescription, and up to 2 prescriptions.
Related Reading
- List of Commodities Subject to BSMI Inspection
- Quantity Limits for Shipping Supplements/Vitamins to Taiwan
- Rules for Shipping Cosmetics/Skincare Products to Taiwan
- Overseas Online Shopping Tax-Free Threshold and 6-Times-Per-Six-Month Limit
- Full Import Tax and Fee Calculator
- CCC Tariff Code Search
Frequently Asked Questions
Legal Basis and Official Sources
- Medical Devices Act: Article 25 (registration and a licence are required for import); Article 35 (the competent authority may grant special approval without being bound by Article 25(1)); and Article 62 (criminal liability for unauthorised import with intent to sell or supply)—Laws & Regulations Database of the Republic of China.
- Regulations on Special Approval for Manufacture and Import of Certain Medical Devices: Article 6(4)(1) (items exclusively for personal use that fall within the listed items and quantities may be imported through the expedited customs clearance channel); Article 6(5) (limited to once per six months, except for inbound travellers carrying items themselves)—Laws & Regulations Database of the Republic of China.
- The items and quantities eligible for licence-free import are governed by the schedule to the Regulations and the competent authority's latest announcements.
- Schedule to the Regulations on Special Approval for Manufacture and Import of Certain Medical Devices (amended 110-04-22, i.e. 2021-04-22): the only application-free items are adhesive bandages, liquid bandages, cotton swabs, condoms, tampons, daily disposable contact lenses, corrective lenses, and medical masks—8 items; Article 7(2) and (3) (consumables exclusively for personal use are limited to a 6-month supply, and instruments to 1 unit per model)—Laws & Regulations Database of the Republic of China.
- Taipei Customs, Customs Administration, Ministry of Finance, entry clearance guidance "Drugs and Medical Devices" (2025-06-24): medical devices outside the schedule require an import licence issued by the TFDA and must be declared to customs on entry.
- TFDA, Ministry of Health and Welfare, "Special Approval for Manufacture or Import of Medical Devices" (5 documents required for personal-use applications, fee NT$2,000, apply by post to the Division of Medical Devices and Cosmetics); TFDA press release of 2025-06-25, "Food, drugs, medical devices and cosmetics brought in by travellers are for personal use only; reselling them after returning may break the law".
- Taiwan FDA: Special Approval for the Manufacture or Import of Medical Devices ｜ Keelung Customs: Note the Categories and Quantity Limits When Importing Small Quantities of Medical Devices for Personal Use
For Personal-Use Medical Devices, Stay Within the Limits and Ship with Confidence
Consolidated shipping for personal-use medical devices such as contact lenses, with a Taiwan-based customs declaration team to help confirm classifications and requirements, plus taxes and fees billed at cost with an invoice. Register to receive your consolidation warehouse address.
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