On 30 June 2026, the Ministry of Health and Welfare (MOHW) announced a draft amendment to the “Standards for Medical Device Administrative Fees”.
The proposed amendment aims to adjust the fee structure for various medical device administrative applications, including medical device registration and license renewal.
Read the full announcement here: https://www.fda.gov.tw/tc/newsContent.aspx?cid=3&id=31589
Purpose of the Draft Amendment
To update the “Standards for Medical Device Administrative Fees”.
To adjust the fee structure for selected medical device administrative applications, including registration, listing, renewal, annual reporting, and classification determination.
Key Updates
The proposed amendment focuses on adjustments to medical device administrative fees.
Key proposed fee adjustments include:
| Item | Proposed Fee (TWD) | Current Fee (TWD) |
| Class II Medical Device Registration | 62,000 | 58,000 |
| Class I Medical Device Registration | 26,000 | 15,000 |
| License Renewal | 10,000 | 8,000 |
| Class I Medical Device Listing | 15,000 | 10,000 |
| Annual Reporting for listing products | 3,000 | 2,000 |
| Classification Determination | 5,000 | 3,500 |
A new fee item is also proposed:
| New Fee Item | Proposed Fee (TWD) |
| Review of clinical trial amendments involving safety | 10,000 |
Implications to Client
Clients should note that:
- Fees for Quality Management System (QMS) inspections, license amendment, advertising applications, and official inquiries remain unchanged.
- TFDA is accepting comments or suggestions regarding the proposed amendments.
- Interested parties may submit feedback to the Taiwan Food and Drug Administration within 60 days following the day after the public announcement.
- Nord Pacific Medical will continue to monitor the progress of these amendments and provide further updates as they become available.
References
Read to learn more:
- TFDA Announcement No. 1151602021 (Traditional Chinese only)
- Comparison Table of Provisions (Traditional Chinese only)
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Taiwan, please contact info@nordpacificmed.com.