Taiwan Drug and Medical Device Import Registration 2026

Imported drugs and medical devices require business licensing, TFDA registration, permits and batch border inspection.

Short answer: what is required?

Western medicines under code 503 and medical devices under code 504 generally require a pharmaceutical or medical device business license, TFDA registration, a drug or medical device permit, and batch border inspection before customs release.

Last updated: 2026-05-27 ยท HowBridge Logistics editorial team ยท Reviewed by AEO customs partner

Contents

  1. 503 drugs and 504 devices
  2. Business license
  3. Drug registration steps
  4. Device registration steps
  5. Device classes
  6. Fees
  7. Personal-use drugs
  8. How to check requirements
  9. FAQ

1. Difference between import codes 503 and 504

Code Scope Authority Permit
503 Human western medicines, including APIs and finished drugs Taiwan TFDA Drug permit
504 Human medical devices, including IVDs Taiwan TFDA Medical device permit
Note: shipments without the required permit may not be imported and may face penalties.

2. First step: pharmaceutical or medical device business license

Before importing drugs or medical devices, the company must apply for the proper business license with the local health bureau.

AuthorityLocal city or county health bureau
License typePharmaceutical sales license or medical device business license
After licensingRegistration and permit application may proceed

3. Five drug registration steps

System: e-sub.fda.gov.tw

1

Obtain business license

Apply for the pharmaceutical business license with the local health bureau.

2

Prepare e-sub documents

Prepare insert draft, GMP documents, stability report, and new drug or generic supporting data.

3

Pay review fee and submit

Pay the review fee based on product type and submit electronically.

4

Document review and GMP inspection

TFDA reviews the file and may inspect the manufacturing site.

5

Receive drug permit and declare batches

After approval, the drug permit is usually valid for five years; each shipment needs border inspection.

4. Four medical device registration steps

1

Confirm device class

Confirm whether the product is Class I, II or III.

2

Prepare administrative and technical files

Prepare license, authorization, specifications, manufacturing data, test reports and clinical data if required.

3

Submit registration or listing

Class I often uses listing; Class II and III generally require registration review.

4

Receive permit and import by batch

After approval, use the medical device permit or listing for each import.

5. Medical device classes

Class Risk Examples Filing method
Class I Low risk Surgical gloves, blood pressure gauge, bandage Listing or registration with fewer documents
Class II Medium risk Electronic blood pressure monitor, medical ultrasound, contact lenses Electronic registration review
Class III High risk Pacemaker, implant screw, heart-lung machine Electronic registration, usually with clinical data

Fees and classifications follow the latest CDE and TFDA announcements.

6. Fee summary

Item Reference amount Note
Drug permit fee About TWD 1,500 per permit Usually valid for five years
New drug review fee About TWD 600,000 Follow TFDA announcement
Generic drug review fee About TWD 20,000-35,000 Follow TFDA announcement
GMP inspection fee About TWD 20,000 per inspection Depends on inspection count
Class III medical device About TWD 100,000 Follow CDE announcement
Class II medical device About TWD 58,000 Follow CDE announcement
Class I medical device registration About TWD 15,000 Follow CDE announcement
Class I medical device listing About TWD 10,000 Follow CDE announcement
Note: fees are references only. Actual amounts follow the latest TFDA and CDE announcements.

7. Personal-use drug import rules

Passenger carry-in: follow TFDA quantity limits for personal-use medicines.
Mail-order personal-use drugs: import consent from TFDA is usually required and the goods cannot be resold.
Commercial resale: requires proper business license and drug permit.

8. How to check whether registration is required

  1. Check CCC code: use Taiwan Customs tariff tools or the single window portal.
  2. Check import rule code: 503 means western medicine; 504 means medical device.
  3. Check existing permits: use TFDA permit lookup where applicable.
  4. HowBridge Logistics tool: use the member customs document tool to match tariff codes and import rules.
TFDA drug section TFDA medical device section e-sub platform Permit lookup Import permit guide

9. FAQ

Must imported drugs be registered first?

Yes. Western medicines with import code 503 require TFDA registration and a drug permit before commercial import.

What license is needed for drug import?

A pharmaceutical business license is required before drug registration.

How are medical devices classified?

Medical devices are divided into Class I, II and III by risk level. Higher classes require more complete review data.

What are the drug permit fee and validity?

The permit fee is about TWD 1,500 per permit and validity is usually five years; review fees are separate.

How much are medical device permit fees?

Follow TFDA and CDE announcements. Common references include about TWD 100,000 for Class III and TWD 58,000 for Class II.

What about personal-use medicine imports?

Passenger carry-in follows quantity limits. Mail-order personal-use medicines usually need import consent and cannot be resold.

This page is general guidance. Actual registration process, fees and review time follow the latest TFDA and CDE announcements.

Not sure whether your goods are drugs or medical devices?

Use the HowBridge Logistics member tool to match CCC codes and import rules, and check whether 503 or 504 registration may apply.

Check import rules View permit guide