TFDA Simplifies Paperwork for Medical Device Applications in Taiwan

From October 1, 2026, the Taiwan Food and Drug Administration (TFDA) will introduce 2 measures to reduce paper handling for medical device applications.

Electronic Class I, II, and III registration, license-change, and renewal applications, documents that would otherwise need to be submitted as originals may instead be uploaded as color-scanned PDF documents, while the applicant retains the originals for inspection. TFDA will also stop issuing paper copies of approved labels, instructions for use (IFUs), and packaging for Class II and III registration and change applications.

Announced on August 25, 2026, the measures aim to improve administrative efficiency and support energy conservation and carbon reduction. Foreign manufacturers and their Taiwan medical device firms or license holders should prepare for the new procedures before they take effect.

What Will Change on October 1, 2026?

The changes depend on the application method and document type:

• Originals (Electronic Applications): Upload color-scanned PDFs and hold originals for inspection (previously mailed to TFDA).
• Approved Class II/III Labels, IFUs & Packaging: License system’s electronic version replaces paper copies (previously issued by TFDA as paper).
• Draft Labels, IFUs & Packaging (Paper Registrations/Changes): Submit 1 copy (previously 2 copies required).

Electronic Applications

Documents uploaded as color-scanned PDFs may include a manufacturing and sale certificate from the country of origin, foreign manufacturer authorization documents, declarations, labels, IFUs, and packaging.

The Taiwan medical device firm or license holder must retain the original documents. Overseas manufacturers should confirm with their Taiwan partner who will hold each document and how it can be produced for inspection.

Electronic applications must pay fees through the system’s electronic platform via online credit card, ATM transfer, Bank of Taiwan payment, or convenience-store payment. Companies should therefore update their internal submission procedures to reflect this payment workflow.

Newly Approved Electronic Labels, IFUs, and Packaging

Approved documents will carry an electronic cross-page seal that can be viewed, downloaded, and printed through TFDA’s medical device license system. When a new version is approved following a change, TFDA will invalidate earlier versions (old paper copies do not need to be returned).

Companies should ensure that newly approved electronic versions are downloaded and appropriately controlled internally, and that superseded labels, IFUs, and packaging are removed from current use.

What Must Applicants Still Send to TFDA?

The procedures are not entirely paperless. After an electronically filed license change or renewal is approved, the applicant must send TFDA a copy of the approval letter and the original medical device license within 1 month for endorsement. Companies must track the 1-month mailing deadline after approval of an electronic license change or renewal.

The envelope should show the approval-letter reference and the responsible TFDA reviewer’s name. TFDA will return the license after recording the approved details.

Cisema supports international medical device manufacturers with end-to-end electronic submission preparation, compliance strategy, and local representation in Taiwan. For expert assistance navigating TFDA's latest regulatory updates, contact Cisema today.

Further Information

• Explore Cisema’s services for medical device registration in Taiwan.
• Read Cisema’s guide to Taiwan medical device classification.

References

• TFDA announcement on electronic review, retention of originals, and electronic approved labeling.