What permits do you need to import medicines or medical devices into Taiwan, and what do 503, 504 and the personal-use rules mean?
What do you need to import medicines or medical devices into Taiwan?
Businesses importing for sale: for medicines, you first need a pharmaceutical dealer license, then a drug permit obtained through registration review (marketing authorization) with the Ministry of Health and Welfare (Taiwan); for medical devices, you first need a medical device dealer license, then a medical device permit or a completed listing. At customs declaration, attach a copy of the permit or a consent document from the Ministry of Health and Welfare under import regulation code 503 (human-use medicines) or 504 (human-use medical devices). Personal use: medicines sent by mail or express courier always require an import consent document from the TFDA, applied for before import; 8 kinds of medical devices, such as daily disposable contact lenses and medical masks, can use an expedited clearance code within quantity limits, once every six months for mail and express shipments (travelers carrying them in person are not subject to this limit).
This guide summarizes Taiwan's import regulations for medicines and medical devices, the licensing process for businesses, and the personal-use rules. HowBridge provides consolidated shipping from mainland China to Taiwan (Shenzhen consolidation warehouse and Taoyuan Dayuan operations warehouse); it is not a customs broker and does not handle permit applications for medicines or medical devices on anyone's behalf. Under Taiwan's regulations on customs clearance of express consignments, medicines, medical devices and other goods subject to import regulations must be cleared with a regular import declaration and cannot use the simplified express declaration. For choices about medicines and medical devices, please consult a doctor or pharmacist.
What are the three ways to bring medicines and medical devices into Taiwan?
The same box of medicine or pair of contact lenses faces completely different rules depending on how it is imported:
1Carried in by arriving travelers
Within the limits announced by the Ministry of Health and Welfare together with the Ministry of Finance (Taiwan), you can carry medicines for personal use without a permit. For example, over-the-counter (OTC) Western medicines are limited to 12 bottles (boxes) of each kind and no more than 36 bottles (boxes) in total; daily disposable contact lenses to 60 lenses per strength, with one brand and 2 strengths per person. Prescription medicines with a prescription and Chinese medicines with a medical certificate have larger allowances; in other cases above the limits, you must apply to the TFDA in advance.
2Mailed or sent by express courier for personal use
Medicines always require an import consent document from the TFDA, applied for before import. For OTC medicines, each application covers no more than 12 bottles, 12 tubes or 1,200 pills in total, and you may not apply again within 6 months. For 8 kinds of personal-use medical devices (such as daily disposable contact lenses and medical masks), you can enter an expedited clearance code within the quantity limits, once every six months.
3Formal import for sale by businesses
First apply to the municipal or county/city health authority for a pharmaceutical dealer or medical device dealer license, then obtain a permit through registration review with the Ministry of Health and Welfare (some medical devices use listing instead). For every shipment, attach a copy of the permit to the customs declaration as the import regulation code requires.
Under Article 12 of Taiwan's Regulations Governing Customs Clearance of Air Express Consignments and of its Regulations Governing Customs Clearance of Sea Express Consignments, express consignments subject to import/export regulations (such as medicines under import regulation code 503 or medical devices under 504) must be cleared with a regular import declaration, except in special cases separately announced by Customs. The permit or the consent document from the Ministry of Health and Welfare must be obtained by the recipient; HowBridge does not apply for import permits for medicines or medical devices on anyone's behalf. If you do not have these documents, please do not send medicines or medical devices to the consolidation warehouse.
What do import regulation codes 503 and 504 mean, and what other codes are there?
The "import regulation" column of the tariff schedule (commonly called the inspection and approval requirements) tells you which documents you need to import. Based on the original code table of the International Trade Administration, MOEA (Taiwan), as of 2026-10-17:
| Code | Key points of the original text | Competent authority |
|---|---|---|
| 503 | Imported human-use medicines (preparations, active pharmaceutical ingredients, diagnostic agents, human biologics): attach copies of the pharmaceutical dealer license and the drug permit, or a consent document issued by the Ministry of Health and Welfare | Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare |
| 504 | Imported human-use medical devices: attach a copy of the medical device permit or a consent document, and enter the 14-character permit number; hazardous medical equipment also requires the medical institution's purchase consent document; not required for devices not intended for human use | Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare |
| 506 | Same as 503, and additionally allows a dedicated code for antibiotics intended solely for research and experiments | Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare |
| 522 | Imported controlled drugs (narcotic drugs, psychotropic substances and their raw materials): require an import certificate or import consent document issued by the TFDA | Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare |
| 502, 505, 814 | Chinese herbal materials (502), Chinese medicine products (505); 814 states that goods without import permit documents from the competent authority are not allowed to be imported | Department of Chinese Medicine and Pharmacy, Ministry of Health and Welfare |
| 802, 804, 818 | Composite codes: depending on the code, 503 (human medicines), 504 (medical devices), 406 (veterinary drugs) or 508 (food additives) applies; if none of these applies, this must be noted on the declaration | TFDA, Ministry of Health and Welfare, and other agencies |
| 839 | Medical masks: handled under 504 and F03 (border inspection); arriving travelers carrying 250 masks or fewer are exempt from 504 | Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare |
| 406 | Veterinary drugs: require a veterinary drug sales business license and an import permit, among others | Animal and Plant Health Inspection Agency, Ministry of Agriculture (Taiwan) |
| MW0 | Mainland Chinese goods not allowed to be imported (see the "Made in mainland China" section below) | International Trade Administration, MOEA (Taiwan) |
- HowBridge tariff database statistics (synchronized with the Customs Administration on 2026-10-11, 12,705 entries in total): 56 tariff lines carry 503 and 137 carry 504; within Chapter 30 (pharmaceutical products), human medicines are spread across codes such as 503, 522, 802, 804 and 814, while veterinary drugs use 406.
- Common products: contact lenses (9001.30) are 504 MW0, blood pressure monitors (9018.90.10) are 504, thermometers (9025.19.90.10) are 504, medical masks made of textile materials (6307.90.50.31) are 839, and other Chinese medicine preparations (3004.90.69) are 814 MW0.
The original texts of both 503 and 504 also list a "consent document" option: 503 requires copies of the pharmaceutical dealer license and the drug permit, or a consent document issued by the Ministry of Health and Welfare; 504 requires a copy of the medical device permit or a consent document. In cases such as special-project approval, samples and gifts, or personal use, you can import with a consent document; personal-use medical devices within quantity limits can also use an expedited clearance code.
Which license must a business hold before importing for sale?
A business license is required before applying for registration review; for medicines, every customs declaration under 503 also requires a copy of the pharmaceutical dealer license. The first step is to apply to the municipal or county/city health authority for a license:
| Item | Medicines | Medical devices |
|---|---|---|
| Business type | Licensed pharmaceutical dealer (Western medicine sellers engaged in wholesale, retail, import and export of Western medicines) | Licensed medical device dealer (sellers engaged in wholesale, retail, import, export, leasing or repair) |
| Legal basis | Pharmaceutical Affairs Act (Taiwan), Articles 15, 27 | Medical Devices Act (Taiwan), Articles 9, 11, 13 |
| Personnel | A Western medicine seller must be managed on site by a full-time pharmacist (sellers that do not sell narcotic drugs may instead use a full-time assistant pharmacist) | Sellers engaged in import must employ technical personnel according to the device category |
| Fees | License fee payable under Article 27 of the Pharmaceutical Affairs Act (amount not verified in this guide) | Application and registration for a medical device dealer license: NT$1,500 |
| At registration review | The application form must include the pharmaceutical dealer license number | Attach a copy of the medical device seller license whose business scope includes "import" |
How does a business complete registration review to import Western medicines?
Article 39 of the Pharmaceutical Affairs Act provides that imported medicines must go through registration review and may be imported only after approval and issuance of a drug permit, by the permit holder and those it authorizes. Main steps:
1Obtain a pharmaceutical dealer license
Apply to the municipal or county/city health authority for approval and registration; you may operate only after receiving the license.
2Prepare the registration review dossier
This includes ingredients, sources of active pharmaceutical ingredients, specifications, performance, a summary of the manufacturing method, test specifications and methods, original and Chinese labels and package inserts, and samples.
3Submit online and pay the review fee
You can submit through the TFDA's Drug Registration Review and Online Application Platform (e-sub) and pay fees under the Standards for Fees for Western Medicine Registration Review.
4Review and factory inspection
Document review; if an on-site inspection of a foreign manufacturer is needed, a separate inspection fee is charged.
5Receive the permit and declare at customs
After approval, collect the drug permit (issuance fee NT$1,500). It is valid for 5 years, and an extension must be applied for in advance before it expires. For each import shipment, attach copies of the license and permit under import regulation code 503.
Does a business importing medical devices need registration review or listing?
Article 25 of the Medical Devices Act: imported medical devices require registration review to obtain a permit; however, items announced by the Ministry of Health and Welfare must be handled by "listing".
1Confirm the classification and class
Compare the item code and class against the annex to the Regulations Governing Classification of Medical Devices (Taiwan); a device whose function or intended use matches no item in the annex is treated as Class 3. You can ask the Ministry of Health and Welfare to confirm the classification.
2Decide between listing and registration review
The Ministry of Health and Welfare's announcement "Medical device items that shall obtain marketing authorization by listing" covers 68 items, effective 2021-10-01. Items not in the announcement (including Class 1 items not listed in it) must go through registration review and cannot use listing instead.
3Submit to obtain a permit or complete listing
A medical device permit issued through registration review is valid for up to 5 years; businesses that have completed listing must file an annual report every year, and the listing lapses if the report is overdue.
4Enter the permit number for each shipment
Under import regulation code 504, attach a copy of the permit or a consent document and enter the 14-character permit number on the declaration.
What are the three classes of medical devices, and which class are common products?
Medical devices are classified by risk into Class 1 (low risk), Class 2 (medium risk) and Class 3 (high risk). Examples in older online sources are often wrong; the list below follows the original annex of the Regulations Governing Classification of Medical Devices:
| Item | Item code | Class |
|---|---|---|
| Soft contact lenses | M.5925 | Class 2 for daily wear only; Class 3 for extended wear |
| Medical face masks | I.4040 | Surgical gowns and face masks worn during surgical procedures are Class 2; all others are Class 1 |
| Non-invasive blood pressure measurement system (blood pressure monitor) | E.1130 | Class 2 |
| Clinical electronic thermometer | J.2910 | Class 2 |
| Surgical gloves | I.4460 | Powder-free: Class 1; with absorbable, biodegradable powder meeting United States Pharmacopeia requirements (such as cornstarch): Class 2 |
| Implantable pacemaker pulse generator | E.3610 | Class 3 |
| Smooth or threaded metallic bone fixation fastener | N.3040 | Class 2 |
| Cardiopulmonary bypass heart-lung machine | E.4220 | Class 2 |
Products of the same type may fall into different classes depending on how they are used; for example, soft contact lenses are Class 2 or 3 depending on how they are worn. The amended annex provisions for medical apparel (I.4040, including medical masks) have applied since 2026-08-22; check the latest version of the annex before importing.
How much are the registration review and permit fees?
Medicines follow the Standards for Fees for Western Medicine Registration Review, and medical devices follow the Standards for Medical Device Administrative Fees; both were set by the Ministry of Health and Welfare (Taiwan):
| Item | Amount | Basis |
|---|---|---|
| Registration review of new-ingredient drug preparations | NT$1,500,000 per application | Standards for Fees for Western Medicine Registration Review, Article 2 |
| Registration review of generic drugs | Monitored drugs NT$140,000; non-monitored drugs NT$80,000 per application | Same standards, Article 2 |
| Inspection of manufacturers in Taiwan (new establishment, relocation, etc.) | From NT$120,000 (additional charges by item) | Same standards, Article 5 |
| On-site inspection of foreign manufacturers | From NT$600,000 if the factory data has been accepted for recordation; from NT$700,000 if not (additional charges by product) | Same standards, Article 5 |
| Drug permit issuance / extension | Issuance NT$1,500; extension NT$10,000 | Same standards, Articles 9, 6 |
| Medical device registration review | Class 3 NT$100,000, Class 2 NT$58,000, Class 1 NT$15,000 | Standards for Medical Device Administrative Fees, Article 2 |
| Medical device listing / annual report | Listing NT$10,000; annual report NT$2,000 | Same standards, Article 2 |
| Medical device permit issuance / extension | Issuance NT$1,500; extension NT$8,000 | Same standards, Article 2 |
| Personal-use special-project application for medical devices | NT$2,000 | Same standards, Article 2 |
The former combined Standards for Fees for Western Medicine and Medical Device Registration Review were abolished on 2020-12-30 and are now split into the two standards above. As for whether individuals must pay a fee to apply for a personal-use drug import consent document, this guide found no explicit provision; please rely on what the TFDA online application platform shows.
Does every import shipment require border inspection?
No. Border sampling inspection applies only to items announced by the Ministry of Health and Welfare: for medicines, under the Regulations for Border Sampling Inspection of Imported Medicaments, only "medicines announced as subject to inspection"; for medical devices, under Annex 1 of the Regulations for Border Sampling Inspection of Imported Medical Devices, currently only 6 items:
| Tariff line (CCC code) | Item |
|---|---|
| 4014.10.00.10 | Condoms |
| 4014.10.00.90 | Condoms containing spermicide |
| 6307.90.50.31 | General medical masks, surgical masks, N95 medical masks (3 items) |
| 3822.19.10.10 | COVID-19 home-use antigen test kits |
- For items requiring inspection, the person obliged to apply must apply to the inspection authority at the port of entry, starting from 15 days before import; this can be done through the TFDA's Border Inspection Automated Management Information System.
- For medical devices, the sampling rate is 2%–10% for general batch sampling and 20%–50% for enhanced batch sampling; for medicines, the batch sampling inspection rate is 2%–50%.
- Medical devices approved solely for personal use are exempt from applying for inspection; a natural person importing an inspection-required item for personal use can clear customs with the dedicated permit code
IF000000000001.
Can personal-use medicines and medical devices be sent to Taiwan?
Legally yes, but you must follow the "personal use" rules, and the rules for mail and express courier differ from those for carrying items in yourself. The following are the legal ways to import for personal use; they do not mean you can simply hand items to a consolidated shipping service to be sent under the simplified declaration:
| Situation | Rule | Basis |
|---|---|---|
| Medicines by mail or express courier | Always apply to the TFDA for an import consent document before import (online drug application platform). OTC medicines: no more than 12 bottles, 12 tubes or 1,200 pills in total per application, and no repeat application within 6 months. Prescription medicines: no more than the reasonable quantity on the prescription, with a medical certificate and the prescription attached | Regulations for Management of Medicament Samples and Gifts (Taiwan), Articles 6, 14 |
| Medical devices by mail or express courier (8 items) | Up to 60 adhesive bandages, 4 liquid bandages, 200 cotton swabs, 60 condoms, 120 tampons, 60 daily disposable contact lenses per strength (one brand, 2 strengths), 1 pair of corrective lenses and 250 medical masks: enter the dedicated expedited clearance code; once every six months | Regulations Governing Special-Project Approval for Manufacture and Import of Specific Medical Devices (Taiwan), Article 6 and annex |
| Above the limits, or medical devices not listed above | For example, monthly contact lenses or blood pressure monitors: apply for special-project approval as a natural person, attaching proof of identity, instructions for use, a signed declaration, and a medical certificate or prescription; fee NT$2,000. Consumables are limited to 6 months' supply, and instruments to 1 unit of the same model (except in special cases such as use at different locations) | Same regulations, Articles 7, 17; fee standards |
| Carried by arriving travelers | OTC Western medicines: up to 12 bottles (boxes) of each kind, 36 bottles (boxes) in total. Prescription medicines: without a prescription, up to 2 months' supply; with a prescription, up to the reasonable quantity and no more than 6 months. Daily disposable contact lenses: as above. Not subject to the once-every-six-months limit | Quantity limits for personal-use medicaments carried by arriving travelers (version in force from 2026-02-01) |
- "Limited to 2 times a year" applies only to OTC medicines: a 2014 press release headline of the Ministry of Health and Welfare said "limited to twice a year", but the regulation itself says OTC medicines "may not be applied for again within six months"; prescription medicines follow the reasonable quantity on the prescription and have no such frequency limit.
- Personal-use items cannot be resold: approved medicament samples and personal-use medical devices may not be sold, transferred or used for other purposes.
- Online sales of medical devices are restricted: according to Ministry of Health and Welfare announcements, only some medical devices may be sold online, the seller must be a licensed medical device dealer or a pharmacy, and the product must hold a permit in Taiwan.
The Customs Administration, Ministry of Finance (Taiwan) warns that a few cold, cough, pain and sleep medicines contain controlled drug ingredients such as codeine, dihydrocodeine, zolpidem, tramadol, ephedrine, pseudoephedrine or methylephedrine; when Customs finds such medicines imported without following the rules, the case is referred to the judicial police for investigation. Before buying medicines from overseas websites, check the ingredients carefully.
What new controls apply to medicines containing semaglutide or tirzepatide from 2026?
Short answer: On 2026-07-23 the Ministry of Health and Welfare announced the “Risk Evaluation and Mitigation Plan for Medicines Containing Semaglutide and Tirzepatide”. Holders of drug permits for these two ingredients must submit a plan to the TFDA for review within 3 months, carry it out once approved and report results every year. The aim is to ensure that a physician evaluates the patient and issues a prescription and that a pharmacist dispenses the medicine. Individuals who import these prescription medicines from abroad by post or express courier still need prior approval under the Pharmaceutical Affairs Act and the Regulations for Management of Medicament Samples and Gifts.
| Item | Key rule | Basis |
|---|---|---|
| Who must act | Permit holders for medicines containing semaglutide or tirzepatide: draw up a plan within 3 months of the announcement date, submit it to the TFDA for review and implement it from the day after approval; later applicants for registration must complete this before the permit is issued | Announcement item 2; Regulations on Drug Safety Surveillance Management, Article 10 |
| Purpose | Ensure every use is preceded by a physician’s professional evaluation and prescription and dispensing by a pharmacist, and that patients understand the potential risks before use | Announcement item 1 |
| Methods | A patient Medication Guide handed to patients; letters to physicians and pharmacists plus training for healthcare professionals; a dedicated plan web page on the permit holder’s website, with its QR code on the carton; in-house adverse reaction monitoring and staff training | Announcement annex “Risk Evaluation and Mitigation Plan”, part 3 (5) |
| Results report | Submitted to the TFDA for review every 1 year (12 months) from the approved start date; the annex says each report is due within 90 days after the data lock point | Announcement item 3; annex part 3 (3) |
| Non-compliance | Handled under the Pharmaceutical Affairs Act; the annex outline of the letter to pharmacists also notes that prescription medicines must not be sold without a prescription, with penalties under Article 92 of the Act | Announcement item 3; Pharmaceutical Affairs Act Articles 50 and 92 |
| Legal basis | Pharmaceutical Affairs Act Article 45 (safety surveillance) and Article 48 (re-evaluation), and Regulations on Drug Safety Surveillance Management Article 10 | “Basis” section of the announcement |
- The announcement regulates permit holders; it is not a new parcel or traveller quota: personal imports still follow the existing rules in the personal-use table above — medicines sent by post or express courier need an import consent from the TFDA before import, and prescription medicines need a medical certificate and the prescription and are limited to a reasonable prescribed quantity (Regulations for Management of Medicament Samples and Gifts, Articles 6 and 14). Medicines imported without approval are prohibited drugs under Article 22 of the Pharmaceutical Affairs Act.
- Prescription-only status: medicines that require a physician’s prescription may not be dispensed or supplied without one (Pharmaceutical Affairs Act Article 50). A TFDA press release of 2026-02-07 also reminds the public that these injections, commonly called “slimming shots”, are prescription medicines that must be prescribed by a physician and dispensed by a pharmacist, and should not be bought online or from unknown sources.
- How to check: ① search the TFDA Western Medicine, Medical Device and Cosmetic Permit Search by ingredient name for Taiwan permits; ② apply for personal-use imports through the personal-use medicine import section; ③ the announcement and its annex on the TFDA announcement page prevail (published 2026-07-23).
Under Article 12 of the Regulations Governing Customs Clearance of Air Express Consignments and of Sea Express Consignments, express consignments subject to import regulations (such as 503 for medicines) must be cleared with a regular import declaration, together with the competent authority’s consent document. Obtain the TFDA approval document first, then ask our customer service to confirm the declaration method.
Can medicines and medical devices made in mainland China be imported?
First check whether the import regulation column of the tariff schedule shows MW0 (mainland Chinese goods not allowed to be imported) or MP1 (conditionally allowed). If neither appears, the item is a mainland product allowed for import, but it must still meet other rules such as 503 and 504.
- Small-quantity permit exemption: under a Ministry of Economic Affairs announcement of 2022-08-19, mainland Chinese industrial products in tariff Chapters 25–97 that are not on the "Restricted Import Goods List", with a CIF value within NT$32,000 and no more than 24 pieces per item (or within 40 kg if not countable by piece), may be imported without a permit and without following the MXX rules. Medicines (Chapter 30) and medical devices in Chapter 90 are not on that list, and the exclusion list announced on 2026-03-10 contains only 3 electric-vehicle items.
- But other rules still apply: the same announcement states that other import regulations must still be followed. Taking contact lenses (504 MW0) as an example, the small-quantity exemption may apply to the MW0 layer, but the 504 layer still requires a permit or a consent document, or use of expedited clearance within the personal-use limits. This is an inference from the original texts of the respective announcements; the competent authority has issued no specific interpretation on "medical devices + MW0".
- Chinese medicine preparations: other Chinese medicine preparations (3004.90.69) are 814 MW0, and the original text of 814 states that goods without import permit documents from the competent authority are not allowed to be imported.
The exemption only waives the import permit of the International Trade Administration; it does not mean the Ministry of Health and Welfare's rules on medicines and medical devices can be skipped. Agricultural and food products in Chapters 1–24 are not eligible for the small-quantity exemption at all. To check your own product, use the tariff search and look at the import regulation column.
What happens if you import without a permit?
Penalties are divided into criminal penalties and administrative fines, and their elements differ, so they should not be lumped together:
| Provision | Content | Key elements |
|---|---|---|
| Pharmaceutical Affairs Act, Articles 22, 82 | Medicines imported without approval are prohibited drugs (except personal-use medicines carried within the announced limits by travelers or crew members of transport vehicles; quantities above the limit are still prohibited drugs). Importing prohibited drugs is punishable by imprisonment of up to 10 years, and a fine of up to NT$100,000,000 may also be imposed; negligent offenses are punishable by up to 3 years | The text of Article 82 contains no "intent to sell" element; seized prohibited drugs are confiscated and destroyed |
| Pharmaceutical Affairs Act, Article 92 | Violating Article 39 (importing without registration review) or other listed provisions is subject to a fine of NT$30,000–2,000,000 | Administrative penalty |
| Medical Devices Act, Article 62 | Importing medical devices without approval with intent to sell or supply is punishable by imprisonment of up to 3 years, detention, and/or a fine of up to NT$10,000,000 | Requires "intent to sell or supply" |
| Medical Devices Act, Article 68 | Importing medical devices without registration review or listing, without special-project approval and outside the personal-use expedited clearance, is subject to a fine of NT$60,000–2,000,000 | Sale is not a required element; a Ministry of Health and Welfare press release of 2025-08-23 explicitly warned the public |
| Medical Devices Act, Article 70 | Selling, supplying, transporting, storing for others, brokering or transferring medical devices without registration review or listing, or displaying them with intent to sell, is subject to a fine of NT$30,000–1,000,000 | Covers distribution acts such as selling, transporting, storing for others, brokering and transferring; not limited to sellers |
| Pharmaceutical Affairs Act, Article 83 | Knowingly selling, supplying, dispensing, transporting, storing for others, brokering or transferring counterfeit or prohibited drugs, or displaying them with intent to sell, is punishable by imprisonment of up to 7 years, and a fine of up to NT$50,000,000 may also be imposed | The element is "knowingly" |
How can I check whether my product is a medicine or a medical device?
Check in this order with these official tools and the tools on this site:
1Check the tariff code and import regulations
Enter the product name in the HowBridge tariff search and see whether the "import regulation" column of the 11-digit CCC code shows codes such as 503, 504, 522 or MW0.
2Check the medical device class
Compare the item codes and classes in the annex to the Regulations Governing Classification of Medical Devices; if unsure, you can ask the Ministry of Health and Welfare.
3Check whether a permit exists in Taiwan
The TFDA's "Western Medicine, Medical Device and Cosmetic Permit and Related Data Search" lets you look up permit data.
4Apply first for personal use
For medicines by mail or express courier, first apply for a personal-use drug special-project import on the TFDA online drug application platform; for medical devices above the limits, apply for special-project approval.
Medicines section: fda.gov.tw sid=38; medical devices section: fda.gov.tw sid=39. The old sid=27 and sid=47 URLs now redirect to the homepage.
What new rules came in 2025–2026?
Amendments related to importing medicines and medical devices over the past year:
- 2025-10-16: import regulation codes 848 and 849 took effect (composite codes for Chinese herbal materials, human specimens and veterinary drugs).
- 2026-02-01: the amended quantity limits for personal-use medicaments and other items carried by arriving travelers took effect (this guide cites the current version).
- 2026-03-04: amendments to the Pharmaceutical Affairs Act were promulgated, revising the reporting rules for the supply of essential medicines and adding Article 27-3 on special-project approval during supply shortages, among other rules; the effective dates of Articles 27-2, 27-3 and 96-1 will be set separately by the Executive Yuan.
- 2026-03-10: the Ministry of Economic Affairs announced the exclusion list for the small-quantity mainland goods permit exemption, which currently contains only 3 electric-vehicle items.
- 2026-07-01: the amended import regulation code 406 (veterinary drugs) took effect.
- 2026-07-23: the Ministry of Health and Welfare announced the “Risk Evaluation and Mitigation Plan for Medicines Containing Semaglutide and Tirzepatide”; permit holders submit plans within 3 months and report results every year once approved (see this section).
- 2026-08-22: the provisions for item I.4040 (medical apparel, including medical masks) in the annex to the medical device classification regulations took effect.
What does research say about buying medicines and medical devices online?
The studies below provide background; none of them were conducted about HowBridge, and they only illustrate general principles:
- The risks of buying medicines online go beyond customs: OECD and EUIPO (2020, Trade in Counterfeit Pharmaceutical Products) analyzed customs seizure data from many countries and found that over 95% of counterfeit pharmaceutical seizures in 2014–2016 involved postal and express shipments, with China, Hong Kong, Singapore and India as the main sources. Tsai (2025, National Taiwan University master's thesis) also notes that Taiwan used to rely mainly on customs and border controls, but online shopping and cross-border platforms now make counterfeit and prohibited drugs easier to circulate. The OECD figures are global, not Taiwanese statistics, and only show that mail and express are the main channels.
- If counterfeit or prohibited drugs cause harm, compensation is hard to obtain: Tsai (2025, Executive Master's Program in Business Law, National Taiwan University) reviews Taiwanese laws and court decisions and notes that because counterfeit and prohibited drugs have not been approved for manufacture or import, users who suffer adverse reactions cannot apply for drug injury relief; people who bought them through illegal channels also often struggle to claim damages because evidence is hard to produce. This is an analysis of legal literature and does not count the number of victims.
- Medical devices are regulated by risk class, but the criminal penalty for importing unapproved devices for sale does not vary by class: Niu (2024, Yuedan Medical Law Report) explains that the Medical Devices Act, in force since 2021, has two mechanisms: risk classification and total product life-cycle management. Lu (2022, Yuedan Medical Law Report) points out that Article 62 of the same Act punishes anyone who imports medical devices without approval with intent to sell by imprisonment of up to three years, applying equally to an adhesive bandage and a high-risk device; the author considers the scope too broad and argues the law should be amended. These two articles are legal commentaries by scholars and represent academic views, not interpretations by the competent authority.
- Quality problems with online pharmacies are widespread internationally: Long et al. (2022, Pharmacy) systematically reviewed 46 studies and found that nearly half of online pharmacies were not properly regulated, and the share of orders in which medicines were actually received ranged from 20% to 100%. Mackey and Nayyar (2016, British Medical Bulletin) note that illegal online pharmacies selling medicines without a prescription are a form of transnational cybercrime that is hard for any single country to tackle alone. WHO (2017) estimated that about 10.5% of tested medicines in low- and middle-income countries were substandard or falsified. These studies cover international or low- and middle-income settings and can only be applied to Taiwan by analogy.
- Saving money is a common motive for buying medicines from abroad: Ghinea et al. (2023, Australian Health Review) surveyed 1,180 middle-aged and older Australians who take medicines and found that 1.8% had personally imported prescription medicines from abroad in the past year, and 44.4% said they would consider doing so to save money; those who believed importing was safe were significantly more likely to have imported. The study covers Australia, which has a legal personal importation scheme that differs from Taiwan's personal-use limits, so it can only illustrate consumer motives by analogy.
What are the common terms in importing medicines and medical devices?
- Import regulation code
- A code on a tariff line indicating which agency's rules apply and which documents must be attached at import, such as 503, 504 or MW0.
- Registration review (marketing authorization)
- A business applies to the Ministry of Health and Welfare for review of a medicine or medical device; only after approval and receipt of a permit may it manufacture or import the product.
- Listing (registration by listing)
- The 68 medical device items announced by the Ministry of Health and Welfare obtain marketing authorization by listing; after listing, an annual report must be filed every year.
- Licensed pharmaceutical dealer
- A business engaged in the manufacture, wholesale, retail, import, export and similar handling of medicines under the Pharmaceutical Affairs Act; it must obtain a license from the local health authority.
- Licensed medical device dealer
- A medical device manufacturer or seller; it must obtain a license from the local competent authority before operating.
- Import consent document
- A document issued by the TFDA, Ministry of Health and Welfare, approving the import of medicaments for personal use, as samples or gifts, or in similar cases; it can replace a permit for customs clearance.
- Expedited clearance code
- A dedicated permit code entered at import for the 8 personal-use medical device items within quantity limits, such as DHM99999999206 for daily disposable contact lenses.
- Prohibited drug (Taiwan legal term)
- A toxic or harmful drug banned by announcement, or a medicine imported without approval; personal-use medicines carried by travelers within the announced limits are excepted, but quantities above the limit are still prohibited drugs.
- MW0
- An import regulation code meaning mainland Chinese goods are not allowed to be imported; for industrial products in Chapters 25–97 that are not on the "Restricted Import Goods List", a separate small-quantity permit exemption applies within CIF NT$32,000 and no more than 24 pieces per item.
What are the sources, and what is the scope of verification?
The sources below were consulted on 2026-10-17. Document dates are shown separately from the access date, and dates not stated in a document are not filled in.
Official and government primary sources
- Pharmaceutical Affairs Act (Presidential order; competent authority: Ministry of Health and Welfare) | Document date: 2026-03-04; definition of pharmaceutical dealers (Articles 14, 15), imported medicines require registration review and a permit (Article 39), permit validity of 5 years and extension (Article 47), prohibited drugs include medicines imported without approval (Article 22), criminal penalty for importing prohibited drugs (Article 82)
- Medical Devices Act (Presidential order; competent authority: Ministry of Health and Welfare) | Document date: 2020-01-15; medical device dealer license (Article 13), registration review or listing (Article 25), permits valid for up to 5 years (Article 27), personal-use special-project approval (Article 35), criminal penalty requires intent to sell or supply (Article 62), fine of NT$60,000 to NT$2,000,000 for import without approval (Article 68)
- Regulations Governing Special-Project Approval for Manufacture and Import of Specific Medical Devices (with annex) (Ministry of Health and Welfare) | Document date: 2021-04-22; expedited clearance quantities for the 8 personal-use medical device items (including daily disposable contact lenses and medical masks), and "except for those carried in by arriving travelers ... once every six months" (Article 6)
- Regulations for Management of Medicament Samples and Gifts (Ministry of Health and Welfare) | Document date: 2022-11-03; personal-use medicines sent by mail or express courier require an application; OTC medicines may not be applied for again within 6 months, with up to 12 bottles or 1,200 pills per application; prescription medicines require a medical certificate and the prescription (Articles 6, 14)
- Regulations Governing Inspection, Taxation and Release of Baggage of Inbound Passengers, Article 4 annex: quantity limits for personal-use medicaments (Ministry of Finance) | Document date: 2026-01-30; limits for arriving travelers on Western medicines (OTC up to 12 of each kind, 36 in total), prescription medicines, Chinese medicines and daily disposable contact lenses (in force from 2026-02-01)
- Standards for Fees for Western Medicine Registration Review (Ministry of Health and Welfare) | Document date: 2020-07-21; new-ingredient new drugs NT$1,500,000, generic drugs NT$80,000 or NT$140,000 (Article 2), GMP inspection NT$120,000 for plants in Taiwan and NT$600,000 or NT$700,000 for on-site inspection abroad (Article 5), drug permit issuance NT$1,500 (Article 9)
- Standards for Medical Device Administrative Fees (Ministry of Health and Welfare) | Document date: 2023-02-23; device registration review: Class 3 NT$100,000, Class 2 NT$58,000, Class 1 NT$15,000; listing NT$10,000; personal-use special-project application NT$2,000 (Article 2)
- Regulations Governing Classification of Medical Devices (with annex) (Ministry of Health and Welfare) | Document date: 2023-08-22; medical devices are divided into three risk classes (Article 3); daily-wear contact lenses are Class 2 and extended-wear lenses Class 3; classes of items such as medical masks and blood pressure monitors (annex)
- Regulations for Border Sampling Inspection of Imported Medicaments (Ministry of Health and Welfare) | Document date: 2020-07-07; border inspection of medicines applies only to "medicines announced as subject to inspection" (Article 3), not to every shipment of medicines
- Regulations for Border Sampling Inspection of Imported Medical Devices (with Annex 1) (Ministry of Health and Welfare) | Document date: 2025-03-31; border inspection of medical devices is limited to the 6 items in Annex 1 (condoms, medical masks, home-use rapid antigen tests); items approved for personal use are exempt from inspection (Articles 3, 5)
- Regulations Governing Permission for Trade Between the Taiwan Area and the Mainland Area (Ministry of Economic Affairs) | Document date: 2024-02-19; mainland goods may not be imported except in enumerated cases (Article 7), the parent legal basis for MW0 and the small-quantity exemption announcement; separate permitted provisions exist for Chinese herbal materials for medical use
- Regulations Governing Issuance of Medical Device Permits, Listing and Annual Reporting, Annex 2 (Ministry of Health and Welfare) | Document date: 2023-11-27; registration review for imported medical devices requires a medical device seller license whose business scope includes "import"
- Import regulation code table (International Trade Administration, MOEA, commodity classification system) | Document date: not stated; official original definitions of import regulation codes such as 503, 504, 506, 522, 505, 814, 802, 804, 818, 839, F03, MW0 and MP1
- Announcement of the "Rules allowing small quantities of mainland goods to be imported without an import permit", Jing-Mao-Zi No. 11104603570 (Ministry of Economic Affairs) | Document date: 2022-08-19; mainland industrial products in Chapters 25 to 97 with a CIF value within NT$32,000 and no more than 24 pieces per item are exempt from permits, but other import regulations (such as 504) must still be met (item 3 of the announcement)
- Announcement of items excluded from the small-quantity mainland goods permit exemption, Jing-Mao-Zi No. 11550200230 (Ministry of Economic Affairs) | Document date: 2026-03-10; the exclusion list contains only 3 electric-vehicle items; medical devices and medicines are not among them
- Summary Table of Imported Goods Checked by Customs on Behalf of Agencies (Table C) (International Trade Administration, MOEA) | Document date: 2026-10-17; contact lenses 9001.30 (504), medical masks 6307.90.50.31 (839) and blood pressure monitors 9018.90.10 (504) are all in Table C, not in the Restricted Import Goods List
- Expedited clearance arrangements (solely for personal use or clinical trials) (Taiwan Food and Drug Administration, Ministry of Health and Welfare) | Document date: 2021-04-27; dedicated permit codes entered at import for the 8 personal-use medical device items (e.g. DHM99999999206 for daily disposable contact lenses), effective 2021-05-01
- Rules and procedures for applying for medical devices solely for personal use (Taiwan Food and Drug Administration, Ministry of Health and Welfare) | Document date: 2021-04-27; personal-use special-project applications for devices above the limits or not in the annex: fee NT$2,000, medical certificate or prescription required
- Section on personal import of medicines for personal use (Taiwan Food and Drug Administration, Ministry of Health and Welfare) | Document date: not stated; online application portal, application forms and notes for personal-use drug special-project imports (apply in advance; OTC medicines may not be applied for again within 6 months)
- Announcement of "Medical device items that shall obtain marketing authorization by listing" (Ministry of Health and Welfare) | Document date: 2021-04-13; only the 68 announced items are marketed by listing, effective 2021-10-01; all other items require registration review
- Border Inspection Automated Management Information System (Taiwan Food and Drug Administration, Ministry of Health and Welfare) | Document date: not stated; online application system for border inspection of imported medicaments and medical devices (tested and reachable on 2026-10-17)
- Western Medicine, Medical Device and Cosmetic Permit and Related Data Search (Taiwan Food and Drug Administration, Ministry of Health and Welfare) | Document date: not stated; check whether a product already holds a drug or medical device permit in Taiwan
- TFDA reminder: importing medical devices for personal use must still comply with the rules (Ministry of Health and Welfare) | Document date: 2025-08-23; explanation by the competent authority: expedited clearance for items such as cotton swabs is limited to once every six months; importing medical devices without approval can be fined NT$60,000 to NT$2,000,000 under Article 68
- From July 1, 2015 (ROC year 104), medicines sent into Taiwan are subject to quantity limits and limited to twice a year, and consent must be applied for in advance (Ministry of Health and Welfare) | Document date: 2014-06-05; medicines sent by mail or express courier always require an import consent document applied for before import; medicines sent in without approval are prohibited drugs ("twice a year" in fact means 1 application per 6 months for OTC medicines)
- Check the ingredients when importing medicines for personal use to avoid breaking the law inadvertently (Customs Administration, Ministry of Finance) | Document date: 2022-02-09; cold medicines, painkillers and sleeping pills bought online that contain controlled ingredients such as codeine, zolpidem or tramadol will be referred for investigation if found by Customs
- Regulations Governing Customs Clearance of Air Express Consignments (Ministry of Finance) | Document date: 2026-02-23; Article 12: express consignments subject to import/export regulations must be cleared with a regular import/export declaration (except special cases announced by Customs)
- Regulations Governing Customs Clearance of Sea Express Consignments (Ministry of Finance) | Document date: 2026-02-23; Article 12: sea express consignments subject to import/export regulations must be cleared with a regular import/export declaration
- Announcement on the “Risk Evaluation and Mitigation Plan for Medicines Containing Semaglutide and Tirzepatide” (Ministry of Health and Welfare, with annex) | Document date: 2026-07-23; based on Pharmaceutical Affairs Act Articles 45 and 48 and Regulations on Drug Safety Surveillance Management Article 10; permit holders submit within 3 months, implement after approval and file a results report every year
- Regulations on Drug Safety Surveillance Management (Ministry of Health and Welfare) | Document date: 2022-04-15; Article 10: for medicines announced by the central health authority, permit holders draw up a risk evaluation and mitigation plan within 3 months and implement it after approval
- TFDA reminder: misuse of “slimming shots” can harm health — do not buy online; a physician’s prescription is required (Taiwan Food and Drug Administration) | Document date: 2026-02-07; prescription medicines that must be prescribed by a physician and dispensed by a pharmacist; do not buy online or from unknown sources
Research literature
Border inspections of imported food and related products in Taiwan from 2011 to 2013
TFDA authors summarize border inspections of imported food at 12 ports and airports in 2011–2013: 1,396,980 batches were inspected and 10,896 were judged non-compliant, using visual inspection, sanitary quality testing and document review; non-compliant items included dietary supplements adulterated with Western drug ingredients. The subject is food and related products, not medicines, so it can only illustrate how Taiwan's border inspection works.
Current development in medical devices postmarket surveillance in Taiwan
Describes post-market surveillance of medical devices in Taiwan: both device adverse events and product defects have online reporting systems, centrally handled since 2005 by the National Adverse Drug Reaction Reporting Center; in 2013 it received 144 device adverse event reports, and 9 of the assessed reports were serious. It shows that approved medical devices continue to be monitored after marketing.
論違法輸入醫療器材罪之刑罰管制
The author notes that Article 62(1) of the Medical Devices Act punishes anyone who imports medical devices without approval with intent to sell or supply by imprisonment of up to three years, applying uniformly regardless of device type or risk level; the author argues this conflicts with the principle of criminal law as a last resort and recommends narrowing criminal penalties according to risk classification. It supports two points: importing unapproved devices for sale carries criminal liability, and the current penalty does not vary by risk class.
醫療器材管理法中全生命週期管理與風險分級的理念與功能
The abstract notes that the Medical Devices Act, in force since 2021, establishes two mechanisms, "total product life-cycle management" and "risk classification", so that medical devices meet safety, performance and quality requirements from development and production through use, in line with major international regulations. It supports the background statement in this guide that medical devices are regulated by risk class.
製造或銷售偽禁藥物之民事侵權責任研究
The abstract notes that counterfeit and prohibited drugs are neither made by qualified manufacturers nor approved for import by the competent authority, so consumers who suffer adverse reactions cannot apply for drug injury relief; people who bought them through illegal channels often find it hard to claim damages because of the burden of proof. The author also observes that control used to focus on customs and borders, but online shopping and cross-border platforms now make counterfeit and prohibited drugs easier to circulate.
Trade in Counterfeit Pharmaceutical Products
Based on customs seizure data, it estimates that international trade in counterfeit pharmaceuticals reached US$4,400,000,000 (USD 4.4 billion) in 2016; over 95% of pharmaceutical seizures in 2014–2016 involved postal and express shipments; the report identifies China, Hong Kong, Singapore and India as the main sources, and notes that free trade zones are also used to repackage goods and disguise their origin. These are global figures, not Taiwanese statistics.
A study on the public health and socioeconomic impact of substandard and falsified medical products
WHO compiled testing studies from low- and middle-income countries and estimated that about 10.5% of tested medicine samples were substandard or falsified. WHO also explains that studies sampling only from the internet were excluded from the estimate, and notes that online pharmacies often sell unapproved medicines, wrong strengths or products lacking active ingredients, while the absence of a doctor or pharmacist check increases the risk. The study covers low- and middle-income countries and can only be applied to Taiwan by analogy.
Online Pharmacies Selling Prescription Drugs: Systematic Review
A systematic review of 46 studies found that the share of orders in which medicines were actually received ranged from 20% to 100%, and the share of consumers buying prescription drugs online was 2.3% to 13%; the authors conclude that nearly half of online pharmacies were not properly regulated and also found fraud. The literature is international, mainly from Europe and North America, and can only be applied to Taiwan by analogy.
Digital danger: a review of the global public health, patient safety and cybersecurity threats posed by illicit online pharmacies
The review notes that illegal online pharmacies sell medicines directly to consumers without a prescription and are a fast-growing public health threat; they are a form of transnational cybercrime, solutions have limited effect as technology keeps changing, and only addressing the whole ecosystem will work. The scope is global, based mainly on English-language literature, and can only be applied to Taiwan by analogy.
The incidence of personal importation of prescription medicines among Australians 45 and older: a cross-sectional survey
A survey of 1,180 Australians aged 45 and over who take prescription medicines: 1.8% had personally imported prescription medicines from abroad in the past 12 months, and 44.4% said they would consider importing to save money; believing importation is safe and knowing about the personal importation scheme were important predictors. The study covers Australia and can only illustrate, by analogy, the motive of buying medicines from abroad to save money.
Legal provisions follow the 2026-10-17 version of Taiwan's Laws and Regulations Database, and import regulation codes follow data exported that day from the International Trade Administration's commodity classification system. The conclusion that the MW0 small-quantity exemption can apply to medical devices is an inference from the original texts of the announcements; the competent authority has issued no specific interpretation. This guide found no explicit provision on whether personal-use drug applications are charged a fee, whether the 2026-02-01 amendment of the quantity limit table changed the medicine entries, or the specific content of the new classification rules for medical masks. The TFDA's old permit search URL info.fda.gov.tw/MLMS could not be reached that day, so whether it is still valid could not be confirmed. None of the studies cited were conducted about HowBridge.
What are common questions about importing medicines and medical devices?
Do you always need a drug permit before importing medicines?
What does import regulation code 504 mean?
Can cold medicine bought on Taobao be sent to Taiwan through a consolidated shipping service?
Is it true you can only mail medicines to Taiwan 2 times a year?
Can daily disposable contact lenses bought online be sent to Taiwan?
Can an individual buy a blood pressure monitor from abroad?
How many classes of medical devices are there?
Does every shipment of medical devices require border inspection?
How often must drug permits and medical device permits be extended?
What happens if you import medical devices without a permit?
Can contact lenses made in mainland China be imported?
What rules apply when an individual imports medicines containing semaglutide or tirzepatide from abroad?
Further reading
Medical device import rules (personal-use limits and duty rates)
Rules for sending supplements and medicines to Taiwan
Controlled drug import rules
Overview of import permits by agency
Arriving traveler allowances
List of goods banned from import into Taiwan
What is a CCC code, and how do you look it up?
International Trade Administration permits for mainland goods (MW0)
Not sure whether your product is a medicine or a medical device?
Enter the product name in the HowBridge tariff search and check the import regulation column of the 11-digit CCC code; if it shows 503, 504, 522 or MW0, confirm the rules before shipping.
Search tariff codes and import regulations