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 by post or express that use the expedited clearance code 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)). “Expedited clearance” is a special code entered on the customs declaration, not a shipping channel; express (including consolidated) imports must still be cleared with a regular import declaration, not the simplified declaration.
- 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: 2026-10-23 (added “New medical device import notices, July–October 2026”: Keelung Customs’ 13 October reminder on cross-border online purchases of medical devices, import regulation code 504 and the expedited clearance codes, the legal basis for formal declaration, and research references; 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) | Within the limits, the expedited clearance code can be entered on the declaration; however, medical devices are goods subject to import regulations, so express imports must be cleared with a regular import declaration, not the EZ WAY simplified declaration. When creating your consolidated shipment, select “Formal declaration” (customs declaration fee NT$800 per batch under current settings; taxes extra) | Obtain the Taiwan FDA personal-use special approval letter first, then select “Formal declaration” when creating your consolidated shipment (customs declaration fee NT$800 per batch; taxes extra) and provide the approval letter. HowBridge does not apply for permits on your behalf; without an approval letter, please do not send the item 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. “Expedited clearance” is a special code entered on the customs declaration—not a shipping channel and not the simplified declaration; express (including consolidated) imports must still be cleared with a regular import declaration.
- 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
- Sent back by express courier (including consolidated shipping) with the expedited clearance code entered on the declaration (express imports must still use a regular import declaration, not the simplified declaration)
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 | 9018.90.10.90.2 | 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: Denied Clearance and Possible Fines
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. Note, however, that importing a medical device without special approval and outside the schedule’s expedited clearance conditions can still be fined NT$60,000–2,000,000 under Article 68(1)(5) of the same Act, and this provision does not require intent to sell. 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. When importing through consolidated shipping, select “Formal declaration” when creating the shipment (customs declaration fee NT$800 per batch under current settings; taxes extra), so that it is cleared with a regular import declaration carrying the expedited clearance code; medical devices cannot use the EZ WAY simplified declaration. Contact lenses most commonly exceed the limit, so remember: a single brand, 60 lenses of a single prescription, and up to 2 prescriptions.
What new notices on importing medical devices were issued in July–October 2026?
In one sentence: on 2026-10-13 Customs again reminded consumers that, apart from the 8 limited personal-use items in the schedule, medical devices bought online from abroad must in principle be approved by the TFDA before import; the rules themselves have not changed, but enforcement and outreach have clearly stepped up.
Notices on medical device imports in the last three months
| Date | Agency | Content | What it means for consolidated-shipping buyers |
|---|---|---|---|
| 2026-10-13 | Keelung Customs, Customs Administration, Ministry of Finance | “Be careful when buying medical devices through cross-border online shopping to avoid penalties”: many everyday products are medical devices; under Articles 25(1) and 35 of the Medical Devices Act, except for a very small number of limited personal-use items, approval from the TFDA must in principle be obtained in advance; unauthorised import may be fined NT$60,000–2,000,000 under Article 68, and import with intent to sell carries criminal liability under Article 62. | Only 8 items are licence-free, and “each importer may use licence-free expedited clearance only once every six months”; going beyond the items, quantities or frequency without prior special approval counts as unauthorised import. |
| 2026-10-22 | Customs Administration, Ministry of Finance | “Check the import regulations before ordering from cross-border online shops to avoid penalties”: a reminder to look up a product’s import regulations before placing an order. | Most tariff lines for medical devices carry import regulation code 504, so check before you order rather than waiting until the parcel reaches customs. |
| 2026-09-10 (in force on promulgation) | Ministry of Health and Welfare | Amendment of Articles 4 and 14 of the Regulations for Medical Device Recalls (Order No. 1151604557): recalled imported devices are in principle sealed and must be re-exported within a deadline; a new proviso lets devices recalled for breaching Article 32 or 33 of the Medical Devices Act (Chinese label, instructions, packaging) be reworked under official supervision, like domestic products, when the Chinese labelling was done in Taiwan by a manufacturer meeting Article 22. | For importers: goods recalled for non-compliant labelling can be reworked under supervision if the Chinese labelling was done by a qualified domestic manufacturer; goods that cannot be reworked in time are still confiscated and destroyed. For individuals: the recall duty lies with medical device firms; authorities may publish product names, batch numbers and reasons under Article 6 of the Regulations, which you can use to check what you own. |
| 2026-08-25 (trial from 2026-10-01) | TFDA, Ministry of Health and Welfare | Medical device registration moves to “online review, originals kept on file”, and paper approved copies of labels, instructions or packaging for Class 2 and 3 devices are no longer issued; electronic versions published in the licence system replace them. | To check whether a model holds a Taiwan medical device licence, search the TFDA licence database directly and download the approved labels and instructions. |
Recall rule amendment and online review: what changes for importers and individuals?
- Article 4(1) of the Recall Regulations (unchanged): medical institutions and medical device firms must stop importing, manufacturing, wholesaling, retailing or displaying for sale the device from the date of the central authority’s announcement, legal determination, or revocation of the manufacturing permit.
- Article 4(2)(ii) (amended 2026-09-10): imported devices are sealed immediately, and the municipal or county (city) authority orders the original importer to re-export them within a deadline; if not returned in time, they are confiscated and destroyed. New proviso: devices breaching Article 32 (Chinese label on the smallest sales package and Chinese instructions) or Article 33 (required label, instruction and packaging particulars) of the Medical Devices Act, whose Chinese label, packaging or instructions were applied in Taiwan by a manufacturer meeting Article 22, follow item (i) instead: rework within a deadline under the local authority’s supervision, with confiscation and destruction if they cannot be or are not reworked in time. The amendment table explains that because the labelling was done by a domestic manufacturer, the recalled devices may be reworked under supervision like domestically made ones.
- Article 14(2) (new): the amended provisions take effect on the date of promulgation, i.e. from 2026-09-10.
- Online review, originals kept on file (TFDA notice of 2026-08-25, trial from 2026-10-01): covers Class 1, 2 and 3 device registration, licence change and extension applications filed through the electronic medical device registration submission system; forms are completed in the system with colour-scanned PDFs uploaded, paper originals are not mailed but kept by the firm; after a change or extension is approved, a copy of the approval letter and the original licence must be mailed to the TFDA within 1 month for endorsement; fees for applications filed through the system can only be paid via its electronic collection platform.
- For personal-use buyers: both notices address medical device firms’ registration, change, extension and recall procedures and do not mention how to apply for personal-use special approval; personal imports still follow the personal-use import rules above.
What does the Medical Devices Act say about imports?
- Article 3 (definition): a medical device is an instrument, apparatus, implement, material, software, in vitro diagnostic reagent or related article that acts on the human body by means other than pharmacological, immunological, metabolic or chemical means to achieve one of these main functions: diagnosing, treating, alleviating or directly preventing human disease; regulating or improving the structure and functions of the human body; or regulating fertility.
- Article 25(1): a medical device may be manufactured or imported only after registration and inspection with the central competent authority and the issue of a medical device licence; items announced by the authority are instead handled by listing. Article 25(3): medical devices shall be imported by the licence holder, the listing holder or a person they authorise.
- Article 35(1)(4): for samples or gifts, or for personal use, the central competent authority may grant special approval that is not bound by Article 25(1).
- Article 62(1): anyone who, with intent to sell or supply, imports medical devices without approval in violation of Article 25(1) is liable to imprisonment of up to 3 years, short-term detention and/or a fine of up to NT$10,000,000.
- Article 68(1)(5): manufacturing or importing medical devices without registration or listing in violation of Article 25(1) is subject to an administrative fine of NT$60,000–2,000,000 (intent to sell is not required).
Personal-use imports: quantity limits and how to apply
Article 6(4)(1) of the Regulations on Special Approval for Manufacture and Import of Certain Medical Devices: items exclusively for personal use that match the listed items and quantities in the schedule may be imported under the expedited clearance arrangement announced by the authority; Article 6(5): except for inbound travellers carrying items themselves, this is limited to once every six months. See the licence-free import list above for the 8 items and quantities. Devices outside the schedule (such as blood pressure monitors, body fat scales and blood glucose meters) require personal-use special approval first; under Article 7 the quantity is 1 unit per model for instruments and 6 months’ supply for consumables. See how to apply above for documents and fees. Keelung Customs’ press release says “each importer may use licence-free expedited clearance only once every six months”, which matches the Regulations; the exemption for inbound travellers carrying items themselves is written into Article 6(5) but is not mentioned in the press release.
Classification: which everyday products are actually medical devices?
Article 3 of the Regulations Governing the Classification of Medical Devices sorts devices by risk into Class 1 (low risk), Class 2 (medium risk) and Class 3 (high risk); under Article 4, a product that fits two or more classes is assigned the higher-risk class. For common items, see the classification table above. If you are unsure, Article 5 allows members of the public to submit an inquiry form with the manufacturer’s instructions and ask the TFDA for a classification. In addition, under Article 3(3) of the Medical Devices Act, non-invasive assistive devices that pose no risk to health and need no help from medical personnel may, with the authority’s approval, be excluded from the list of medical devices. So “looks like a medical device” does not mean “is a medical device”, and vice versa: the competent authority’s determination is what counts.
How does import regulation code 504 relate to formal declaration?
At import, customs uses the “CCC tariff code + import regulation code” to decide which documents are required. The code most often seen on medical devices is 504. The codes you may meet on a declaration are:
| Code | Key wording of the rule | What a personal-use importer needs |
|---|---|---|
| 504 | Medical devices for human use must be imported with a copy of the medical device licence or a consent document issued by the Ministry of Health and Welfare, and the 14-digit licence number must be declared; devices not for human use are exempt. | Devices outside the schedule: the TFDA’s personal-use special approval letter (consent document). |
| DHM99999999201–208 | Ministry of Health and Welfare notice of 2021-04-27, effective 2021-05-01: imports meeting Article 6(4)(1) of the Regulations declare a dedicated code, with quantity unit PCE. 201 adhesive bandages, 202 liquid bandages, 203 cotton swabs, 204 condoms, 205 tampons, 206 daily disposable contact lenses, 207 corrective lenses, 208 medical masks. | Within the limits of the 8 schedule items: enter the matching code on the declaration; no separate permit is needed (the once-every-six-months limit still applies). |
| F03 | Imported medical devices must undergo import inspection with the TFDA under the Regulations for Border Inspection of Imported Medical Devices. | For example, condom tariff line 4014.10.00.10.2 carries “504 F03”; whether a shipment is inspected depends on the TFDA. |
| 839 | Medical masks: rules 504 and F03 apply; inbound travellers carrying a total of 250 masks or fewer are exempt from rule 504. | The 250-mask exemption for travellers is in code 839; post and express shipments use schedule code 208. |
| MW0 | Mainland China goods may not be imported. | Of the 137 tariff lines carrying 504 in our tariff database, 29 also carry MW0 (20 in Chapter 90, 7 in Chapter 30), e.g. contact lenses 9001.30.00.00.5. All of them are in Chapters 25–97: the Ministry of Economic Affairs’ small-quantity licence exemption (excluded items aside) deals only with the MW0 hurdle, while the TFDA permit under 504 must still be met separately — the two are assessed independently. |
Why formal declaration? Article 12(1)(2) of both the Regulations Governing Clearance of Express Consignments by Air and the Regulations Governing Clearance of Express Consignments by Sea states that express consignments “involving import or export regulations” must be cleared with a regular import or export declaration (proviso: in special cases announced by Customs, a simplified declaration may be used). Medical devices carry 504, so they involve import regulations. When importing through consolidated shipping, select “Formal declaration” when creating the shipment; our partner customs broker files a regular import declaration and enters the licence number, the special approval document or the expedited clearance code. HowBridge (Shenzhen and Taoyuan warehouses, China to Taiwan) does not apply for TFDA permits on your behalf.
Buying medical devices online from China: 4 checks before you order
- Confirm whether it is a medical device: search the TFDA licence database to see whether the same model holds a Taiwan medical device licence, or ask the TFDA for a classification under Article 5 of the Classification Regulations.
- Look up the CCC code and import regulations: use the tariff code search to see whether it carries codes such as 504, F03 or MW0.
- Check the personal-use rules: use the expedited clearance code only if the item is one of the 8 schedule items, within the quantity limit, and you have not used this half-year’s allowance; for anything else, obtain a special approval letter before shipping.
- Choose “Formal declaration” when creating the consolidated shipment and declare the product name, quantity and purpose truthfully; personal-use items may not be resold.
Further research and international documents
- “The Research of the Penalties of Illegal Import Medical Devices” (article in Chinese), Angle Health Law Review, No. 71 (September 2022) — reviews the scope of criminal penalties for importing medical devices in light of risk-based classification
- Yin, Chi Yen, “A Study on Regulations for the Supervision and Administration of Medical Devices in China”, master’s thesis, National Chengchi University (2016, in Chinese)
- WHO, Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices (2017) — recommends regulating medical devices through binding law and using GHTF/IMDRF harmonised definitions
- WCO Framework of Standards on Cross-Border E-Commerce (2018) — risk management for e-commerce goods and public awareness
Sources for this section (checked 2026-10-23)：Keelung Customs, 2026-10-13: be careful when buying medical devices online across borders ｜ Customs Administration, 2026-10-22: check import regulations before ordering online ｜ TFDA, 2026-08-25: online review trial for device registration, paper approved copies discontinued ｜ Ministry of Health and Welfare notice of 2021-04-27: dedicated expedited clearance codes ｜ Medical Devices Act (Laws & Regulations Database) ｜ Regulations Governing the Classification of Medical Devices (Laws & Regulations Database) ｜ Regulations Governing Clearance of Express Consignments by Air, Article 12 (Laws & Regulations Database) ｜ TFDA, 2026-09-10: Amendment of Articles 4 and 14 of the Regulations for Medical Device Recalls ｜ Regulations for Medical Device Recalls (Laws & Regulations Database, amended 2026-09-10)
※ The wording of codes 504/F03/839/MW0 and the tariff-line counts come from our tariff database (synchronised with Trade Administration data, version of 2026-10-21); the latest announcements of the Trade Administration and Customs prevail. This section explains the rules and how to check them; whether a particular product may be imported is determined by the TFDA and Customs.
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".
- Keelung Customs, 2026-10-13, “Be careful when buying medical devices through cross-border online shopping to avoid penalties”; Ministry of Health and Welfare notice of 2021-04-27 (dedicated expedited clearance codes DHM99999999201–208, quantity unit PCE); Regulations Governing the Classification of Medical Devices, Articles 3–5; Regulations Governing Clearance of Express Consignments by Air and by Sea, Article 12(1)(2) — checked 2026-10-23.
- Regulations for Medical Device Recalls, Articles 4 and 14 (Order No. 1151604557, amended 2026-09-10, in force on promulgation); TFDA notice of 2026-08-25 on “online review, originals kept on file” for medical device registration — checked 2026-10-23.
- 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
Personal-Use Medical Devices: Confirm the Permit First, Then Ship with Formal Declaration
Medical devices are goods subject to import regulations. When imported through consolidated shipping, select “Formal declaration” so they are cleared with a regular import declaration (customs declaration fee NT$800 per batch under current settings; taxes extra); the EZ WAY simplified declaration cannot be used. For medical devices outside the schedule, obtain the Taiwan FDA special approval letter yourself first. HowBridge does not apply for permits on your behalf; without the documents, please do not send the item to the consolidation warehouse. Register to receive your consolidation warehouse address.
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