Taiwan Simplifies Medical Device Submissions: New Digital Measures Take Effect in October 2026

What’s Changing?

Taiwan’s Food and Drug Administration (TFDA) is introducing two trial measures designed to simplify administrative procedures for medical-device registration, licence changes and renewals.

Announced on 25 August 2026, the measures will take effect on 1 October 2026. They focus on:

• Online review with original documents retained for inspection

• Ending the issuance of paper-approved copies of medical-device labels, instructions for use and packaging

The changes are intended to improve administrative efficiency and support digitalisation and paper reduction.

1. Moving Further Towards Digital Submissions

For applications submitted through Taiwan’s electronic medical-device registration system, certain supporting documents can be completed and uploaded electronically as colour-scanned PDF files.

These include documents such as certificates of approval or sale from the country of origin, authorisation documents from overseas manufacturers, declarations, and relevant label, instruction or packaging materials.

Under the new trial measure, applicants will no longer need to send these original paper documents separately to TFDA. Instead, the medical-device company or licence holder must retain the originals for future inspection.

This approach applies to relevant registration, licence amendment and renewal applications handled through the electronic system.

However, companies should note that the original licence may still need to be sent to TFDA in certain approved amendment or renewal cases for the licence-recording process.

2. Paper-Approved Copies Are Being Replaced

From 1 October 2026, TFDA will also stop issuing paper-approved copies for labels, instructions for use and packaging associated with approved Class II and Class III medical-device registration or amendment applications.

Instead, approved electronic versions will be published through TFDA’s medical-device licence system. The new electronic versions will carry an electronic seal and can be searched, downloaded and printed from the system.

This means companies will need to become increasingly comfortable managing approved regulatory information through digital systems rather than relying on physical approved copies.

3. What About Paper Applications?

The changes also simplify certain paper submissions.

For paper-based registration or licence amendment applications, companies may submit one copy of proposed labels, instructions for use or packaging rather than the two copies previously required under the applicable rules.

TFDA has also specified electronic-file requirements for certain types of licence amendments, including changes involving approved company or manufacturer names and addresses, product names, or the cancellation or deletion of specifications.

Who Should Pay Attention?

These measures are particularly relevant to:

✔ Medical-device manufacturers

✔ Licence holders in Taiwan

✔ Companies using TFDA’s electronic submission system

✔ Regulatory affairs teams

✔ Local representatives and authorised partners

✔ Companies planning registration, licence amendments or renewals

For international manufacturers, the changes are especially relevant when working with local regulatory partners responsible for maintaining submissions and official documentation.

What Should Companies Do Now?

1. Review Your Submission Process

Companies planning applications from 1 October 2026 should review how they prepare and submit supporting documentation.

If using the electronic submission system, teams should ensure they can prepare complete, legible colour-scanned PDF versions of the required original documents.

2. Strengthen Document Retention

The removal of the requirement to send certain originals does not mean the originals are no longer important.

Companies and licence holders remain responsible for retaining them for inspection when required. Good document control will therefore remain essential.

3. Update Internal Checklists

Regulatory teams should update submission checklists and standard operating procedures to reflect:

• Electronic uploading requirements

• Original-document retention responsibilities

• The new electronic approach to approved labels, instructions and packaging

• Applicable fee-payment procedures for electronic submissions

From 1 October, applications submitted through the electronic system will also use the system's electronic payment platform for fee payments.

4. Coordinate With Local Partners

International manufacturers should ensure that responsibilities for maintaining original documents, managing electronic submissions and accessing approved electronic records are clearly agreed with their Taiwan-based partners.

ARQon Insight

Taiwan’s latest measures show how regulatory administration is increasingly moving towards digital processes.

But digitalisation does not mean less compliance.

In fact, when regulators reduce paper handling, the importance of document control, record retention and electronic regulatory management can become even greater.

For manufacturers, the key question is no longer simply:

“Do we have the right documents?”

It is also:

“Can we manage, maintain and retrieve those documents efficiently in a digital regulatory environment?”

What This Means for Market Access

Administrative simplification can make regulatory processes more efficient, but companies still need strong systems behind the scenes.

For businesses entering Taiwan, the regulatory journey increasingly involves:

Digital submission → Document control → Regulatory approval → Electronic records → Ongoing licence maintenance

Companies that continue relying on outdated paper-based workflows may need to adjust their internal processes and coordination with local partners.

The changes are therefore a practical reminder that regulatory strategy and operational readiness must evolve together.

Key Takeaway

Taiwan’s TFDA announced on 25 August 2026 two trial simplification measures that will take effect on 1 October 2026.

The measures will enable more fully digital handling of relevant medical-device submissions through an “online review, originals retained for inspection” approach and will replace paper-approved copies of certain labels, instructions and packaging with electronic versions available through TFDA’s system.

For medical-device manufacturers and regulatory teams, the development is a clear signal to review electronic submission processes, document-retention practices and internal regulatory workflows ahead of October.

Simpler administration. Stronger digital readiness. The same responsibility for compliance.

How ARQon Can Support

ARQon supports healthcare and life-science companies with:

• Regulatory intelligence and monitoring

• Taiwan market-entry strategy

• Medical-device registration support

• Regulatory documentation planning

• Licence amendment and maintenance support

• Regulatory gap analysis

• Cross-border market-access strategy

Stay Ahead. Stay Compliant. Stay Informed.

With ARQon Regulatory Intelligence.