Taiwan Medical Device Registration: Requirements and Process

Leave a comment

Taiwan medical device registration is mandatory before a device can be manufactured in or imported into Taiwan. The Taiwan Food and Drug Administration (TFDA), an agency under the Ministry of Health and Welfare (MOHW), reviews applications and issues medical device licenses. Foreign manufacturers without an office in Taiwan must work through a local license holder. Most devices also require a Quality System Documentation (QSD) approval for the manufacturing site.

Taiwan regulates medical devices under a dedicated law, the Medical Devices Act, which took effect on May 1, 2021. This article outlines the current requirements and process for Taiwan medical device registration.

Regulatory Framework

The Medical Devices Act, announced on January 15, 2020, and implemented on May 1, 2021, replaced the device provisions of the Pharmaceutical Affairs Act. Under Article 25, no medical device may be imported until the TFDA approves it and issues a medical device license, except for products the authority designates for listing. Article 22 requires overseas manufacturers to maintain a quality management system and pass a compliance inspection.

Medical Device Classification in Taiwan

Taiwan uses a three-tier, risk-based classification system. Class I covers low-risk devices, Class II covers moderate-risk devices, and Class III covers high-risk devices. The TFDA also treats products with no predicate in its classification database as new medical devices, which undergo the most extensive review.

The classification regulations divide devices into 16 functional categories. Each device type carries a code made up of a letter from A to P and four digits. Manufacturers determine the class by searching the TFDA classification database for the matching device type and predicate products. If the classification remains unclear, the applicant can submit a classification inquiry to the TFDA, which takes approximately 90 calendar days.

The device class determines whether the product requires listing or a license, whether the manufacturer needs QSD approval, and the level of technical and clinical data the TFDA expects.

Local License Holder and QSD Requirements

Foreign manufacturers cannot apply to the TFDA directly. Instead, they must authorize a local Taiwan company to submit the application and hold the medical device license. Under Article 13 of the Medical Devices Act, only registered medical device firms may manufacture or deal in medical devices, so the license holder must hold a medical device business permit from its local health authority. The license holder’s details and the license number must also appear on the approved device’s Chinese label.

Manufacturers can appoint a subsidiary, a distributor, or an independent third-party consultant as their license holder. Licenses can transfer between license holders through a joint application, which allows a manufacturer to change distributors without re-registering its products.

In addition, each manufacturing site must obtain QSD approval before the TFDA issues a license for Class II devices, Class III devices, new devices, and sterile or measuring Class I devices. Non-sterile, non-measuring Class I devices are exempt. QSD review typically takes 6 to 10 months and can run in parallel with product registration.

The Taiwan Medical Device Registration Process

The registration process for Class II and Class III devices follows four main steps.

  1. Appoint a local license holder (local agent) and confirm the device classification and predicate products.
  2. Submit the QSD application for each manufacturing site.
  3. Prepare and submit the product registration dossier.
  4. Respond to TFDA questions during administrative and technical review. The TFDA issues the license after it approves both the product registration and the QSD.

The applicant can submit the product registration before QSD approval to shorten the overall timeline. During review, the TFDA allows one month to correct missing administrative documents and three months to respond to technical deficiencies.

Class I devices follow a simpler route. Most Class I devices undergo administrative review only, with no technical review. Moreover, under Article 25 of the Medical Devices Act, the TFDA designates certain low-risk Class I device types for listing instead of licensing. Companies with listed medical devices must file an annual declaration with the TFDA under Article 28. As of 2026, the TFDA also accepts some low-risk Class I registration applications through its Medical Device Premarket E-submission System, with no hard copies required.

The TFDA requires clinical evidence for new devices and Class III IVDs, and it may request clinical data for other Class III devices too. The TFDA generally accepts foreign clinical data. Class II and Class III applications also require proof of marketing approval in the country of origin, and the TFDA may waive certain preclinical tests when the applicant provides equivalent data from that approval.

Timelines and License Validity

The TFDA’s review targets  are approximately 140 calendar days for Class II devices and 200 to 220 calendar days for Class III and new devices. Including dossier preparation, QSD review, and deficiency responses, industry estimates place total timelines at 1 to 2 months for Class I devices without QSD, 8 to 12 months for Class II devices, 9 to 14 months for Class III devices, and 10 to 15 months for new devices.

Under Article 27 of the Medical Devices Act, a Taiwan medical device license is valid for up to five years. The license holder must apply for renewal before the license expires, and each renewal extends the license for up to five years. The TFDA accepts renewal applications within six months before expiry.

Post-Market Obligations

Under the Regulations for Reporting Serious Adverse Events of Medical Devices, license holders and listed firms must report serious adverse events to the TFDA within 15 days of becoming aware of them. Serious adverse events include death, life-threatening conditions, permanent disability, congenital anomalies, and hospitalization or prolonged hospitalization. License holders must also keep adverse event records for at least five years.

Article 47 allows the TFDA to require safety monitoring and periodic reports for designated devices. Class III devices must carry a Unique Device Identifier (UDI) as of June 1, 2022, and Class II devices as of June 1, 2023.

Conclusion

Taiwan medical device registration requires foreign manufacturers to appoint a local license holder, classify the device, obtain QSD approval for each manufacturing site, and submit a product registration dossier to the TFDA. After approval, license holders must renew the license every five years, report serious adverse events within 15 days, and meet UDI and labeling requirements. Because QSD review and product review can run in parallel, manufacturers that prepare both submissions early can reduce the time needed to reach the Taiwanese market.

Pacific Bridge Medical has assisted international medical device companies with Taiwan medical device registration and local license holder services for many years. For more information, please contact Pacific Bridge Medical.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.