Over the past few years, Taiwan has enacted several significant reforms that have reshaped the regulatory framework for medical devices. These changes encompass a diverse range of topics, from regenerative medicine and digital health to product registration and classification, as well as import inspections and reimbursement policies. Each change reflects the government’s commitment to enhance oversight, foster innovation, and ultimately bring new technologies to Taiwanese patients.
Development of Regenerative Medicine Framework
Taiwan established a legal foundation for therapies utilizing cells and tissues in June 2024, when it enacted the Regenerative Medicine Act and the Regenerative Medicine Product Act. Since then, the Ministry of Health and Welfare (MOHW) has issued draft regulations to implement these new laws.
The MOHW published six draft regulations under the Regenerative Medicine Act on February 17, 2025, regarding matters such as: the role of the review committee, research incentives, treatment efforts, informed consent, advertising standards, and adverse reaction reporting. Between August 2024 and February 2025, the MOHW also published four draft regulations under the Regenerative Medicine Product Act to address safety monitoring, data retention in the supply chain, advertising restrictions, and consent procedures.
All draft regulations were subject to public consultation for 60 days, and the MOHW anticipates implementation of all regulations in late 2025. Once finalized, this will represent an important milestone for the healthcare industry in Taiwan.
Expansion of Insurance Coverage for Robotic Surgery
Taiwan’s National Health Insurance (NHI) program significantly expanded its coverage of robotic surgical procedures beginning in March 2025. Before then, only radical prostatectomies and partial nephrectomies performed using robotic systems were eligible for reimbursement. The expansion will now include a total of 17 types of robotic surgery.
The expansion is a significant milestone for both hospitals and patients, who will not have to pay as much out of pocket, and further encourages hospitals to invest in advanced surgical technology. Companies like Intuitive Surgical, which has been active in Taiwan since 2004, will also clearly benefit from this policy change.
New Requirements for Device Registration and Quality Documentation
On November 27, 2023, Taiwan’s Food and Drug Administration (TFDA) issued an amendment to the Regulations Governing Issuance of Medical Device License, Listing, and Annual Declaration. Most prominently, the amendment mandates the inclusion of Quality System Documentation (QSD) numbers of medical device manufacturing facilities on all product licenses, except for a group of 125 non-sterile Class I products. Prior to the amendment, product approvals did not require this information. Existing devices that have already been approved by the TFDA will not need to adhere to this change, but the QSD number will need to be added during license renewal or when submitting a change notification.
The amendment also reduced the timeframe for correcting deficiencies identified during the preliminary review stage to one month to provide any missing documents, rather than the previous four-month timeframe. Nevertheless, the revision does not alter the three-month timeframe for responding to substantial review responses.
In addition, the TFDA unveiled a streamlined registration pathway for 140 device categories, as long as the products are similar to those already registered by the same manufacturer and supported by a conformity statement.
New UDI Requirements for Class II and III Devices
On February 14, 2024, the TFDA revised its Unique Device Identification (UDI) regulations. Class II and Class III devices must display a UDI code stamped on the outer frame of the packaging. In the case of small-sized devices, the UDI must now be affixed directly onto the sales package. Exemptions are applied to custom-made devices and to products that are intended solely for export or for medical components.
These updates reinforce Taiwan’s initial UDI system that was first implemented in 2020, and serve to improve traceability and post-marketing safety monitoring.
Stricter Import Inspections at the Border
In March 2025, the MOHW made amendments to the existing Regulations Governing Border Inspection and Examination of Imported Medical Devices. The changes further explain which devices will be subject to border inspection and revise the testing requirements and sampling rates.
Importers are now required to apply for inspection 15 days in advance of customs clearance and must correct deficiencies within 20 days. The frequency of inspections is based on risk. Devices with prior nonconformance will likely have reinforced inspections, inspections conducted on a batch-by-batch basis, or increased sampling rates.
Tougher Classification Rules for Unlisted Devices
Taiwan also updated its medical device classification, with implications for innovative products. According to the amendment in August 2023, if a function or intended use of a device is not classified in the classification annex, the device is classified as Class III – the highest risk classification.
Manufacturers can still claim a predicate device that proves that their product is the same as a device previously approved in Taiwan. However, if there are no predicate devices approved in Taiwan, manufacturers must prepare for the more rigorous requirements applicable to Class III new devices.
Conclusion
These changes show Taiwan’s determination to strengthen its medical device regulatory system. For companies seeking to enter or expand in this market, careful early planning, a solid quality management system, and proactive compliance measures will be essential.
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.