In 1993, Pharmaceutical Affairs Act was enacted to facilitate the creation of a congenial environment for the development of both the drug and medical device industry in Taiwan. However, as time goes by, drugs and medical devices are too profound, and laws and regulations specifically for medical devices have collaborated globally. To keep in line with international norms, and further ensure the safety, effectiveness, and quality of medical devices, Medical Device Act was released on Jan 15th, 2020, and have come into force on May 1st, 2021.

Unlike Pharmaceutical Affairs Act, Medical Device Act focuses only on medical devices and their related matters. In addition, to fully manage the product life cycle, Medical Device Act not only strengthens the governance of manufacturers and distributors but also considers designers and maintainers part of the industry.


Below lists out the supporting measures and announcements that were launched following Medical Device Act:

1. Overview of the Act


2. Charging of Regulatory Fees

There is an increase in most regulatory fees. For instance, QSD application fees have raised from NTD38,000 to NTD60,000, and Class III Product Registration fees have raised from NTD38,000 to NTD100,000.

3. Regulations Related to Manufacturers

As designing is regarded as part of the manufacturing phase, the establishment of manufacturers is modified. Moreover, to encourage innovative products, a special regulation was launched.


4. Regulations Related to Distributors

 For distributors in Taiwan, the implementation of Good Distribution Practice (GDP) is a major difference from the past. TFDA has additionally requested medical device dealers of specific product categories to obtain both the Distribution License and the Medical Device License before selling, wholesaling, importing, or exporting medical devices.


5. Management of Testing Institutions

In order to carry out the certification or entrusted certification of medical device testing institutions, and to improve the management of these institutions, several regulations were established based on ISO/IEC 17025.


6. Product Registration

For low-risk class I medical devices, there is a new registration approach- Medical Device Listing. Those medical devices shall be registered online and renew their listing annually.

For medical devices that required QSD (Quality System Documentation), not only brand owners (legal manufacturers) need to apply for QSD, contract manufacturers (OEM, ODM sites) are also required. In addition, TFDA has canceled the abbreviated approach for medical devices that had obtained both US and EC certificates. Instead, alternative approaches are released for products that are well known on the market.


7. Requirements of Product Label, IFU, and Package


8. Regulations Related to Clinical Trials

To protect the rights, safety, and well-being of subjects and to ensure all clinical trials are ethical and scientific-based, Good Clinical Practice (GCP) is adapted and should be carried throughout all clinical trials.


9. Tracking and Tracing of Medical Devices

Unique Device Identifier (UDI) system is implemented to keep track of each medical device from manufacturing process to patient use. Through establishing UDI, both TFDA and manufacturers could better identify potential problems or device defects, leading to the improvement of patient welfare.


10. Safety Surveillance of Medical Devices

To further develop a more practical and useful safety surveillance system, TFDA has released new regulations related to adverse events reporting and product recall.​​​​


11. Other




Medical Device Act