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A Regulatory Turning Point

Taiwan’s Medical Devices Act, which officially came into force in May 2021, marked a significant regulatory milestone for the island’s healthcare and manufacturing sectors. Its origins lie in the increasing complexity of medical technology and the need to create a more agile, transparent, and internationally aligned regulatory system.

Historical Background: Why the Reform Was Needed

Prior to the Medical Devices Act, medical devices in Taiwan were regulated under the Pharmaceutical Affairs Act (PAA)—the same legislation used for drugs. This framework, originally designed for pharmaceuticals, proved increasingly inadequate for regulating the diversity and rapid evolution of medical devices, especially as software-driven and wearable health technologies began to proliferate.

Manufacturers, both local and international, found the drug-based classification system cumbersome. Devices were treated similarly to medications, requiring overlapping documentation, limited flexibility, and prolonged review cycles. Moreover, with Taiwan aspiring to become a competitive player in global health technology supply chains, the need to harmonize with international standards (such as those of the U.S. FDA, EU MDR, and Japan’s PMDA) became urgent.

Thus, Taiwan’s government and industry stakeholders began working on a dedicated law for medical devices, aiming to balance safety with innovation and remove regulatory bottlenecks for local manufacturers and global investors.

Legislative Milestones and Enactment

After years of consultation with manufacturers, regulatory experts, hospitals, and international partners, the Medical Devices Act was passed by the Legislative Yuan in January 2020 and officially enacted on May 1, 2021. The Taiwan Food and Drug Administration (TFDA) was designated the primary implementing body, with an updated structure, enhanced oversight authority, and digitized processes.

Core Objectives of the Medical Devices Act

The Act was designed with several clear goals in mind:

? Improve regulatory efficiency for device approval and post-market monitoring

? Create a dedicated, risk-based framework specific to devices, distinct from drug regulation

? Align with global regulatory systems, making Taiwan’s devices more exportable

? Encourage innovation in high-tech, digital, and AI-based medical equipment

Key Features of the Medical Devices Act

1. Risk-Based Classification System

Devices are now classified into three categories:

o Class I: Low-risk devices (e.g., bandages, tongue depressors)

o Class II: Moderate-risk devices (e.g., infusion pumps, diagnostic imaging)

o Class III: High-risk devices (e.g., implantable pacemakers, surgical robots)

This system determines the level of documentation, clinical evidence, and testing required. It also enables regulators to focus resources on higher-risk devices, while allowing faster paths for lower-risk innovations.

2. E-Submission Portal for Class II & III Devices

A major modernization under the Act is the introduction of a centralized electronic submission platform. This online portal allows manufacturers to upload documents, clinical trial data, and compliance certifications. The system is especially beneficial for international companies seeking market entry, as it streamlines communication and shortens approval timelines.

3. International Harmonization and Fast-Track Review

To ease global integration, the Act allows devices that have already been approved by internationally recognized regulatory bodies—such as the U.S. FDA, EU CE, or Japan’s PMDA—to leverage existing documentation. This reduces redundant testing and expedites approvals under Taiwan’s “fast-track” mechanisms.

4. Post-Market Surveillance and Vigilance Requirements

Manufacturers are now required to maintain post-market surveillance systems, report adverse events, and cooperate with the TFDA on recalls or safety audits. The Act grants the TFDA expanded authority to enforce recalls and mandate corrective actions, creating a safer environment for patients and providers.

5. Third-Party Review Bodies

To improve efficiency, the TFDA is authorizing designated third-party technical assessment bodies to assist in the review of specific device classes. This decentralization of assessments helps reduce backlog and improve industry responsiveness.

6. Import & Export Licensing Simplification

Companies importing or exporting medical devices benefit from clearer licensing processes. The Act delineates responsibilities between domestic licensing, contract manufacturing, and OEM-export models—something that was previously ambiguous under the PAA.

Impact on the Industry

Since implementation, the Medical Devices Act has led to:

? Faster product launches, particularly for Class I and II devices

? Higher investor confidence, thanks to alignment with international standards

? Increased exports, especially in diagnostic and home care devices

? More local innovation, especially in telemedicine, wearable devices, and AI diagnostics

Industry Leaders: Pioneering Innovation and Quality

Several Taiwanese companies have taken advantage of the streamlined approval process to bring new products to international markets more efficiently.

Wellell streamlined the approval of its therapeutic support surfaces, respiratory therapy devices, and sterilization equipment by aligning product classifications with the TFDA’s risk-based system and fast-tracking CE-certified devices through the e-submission portal.

Unison Healthcare Group, with its comprehensive range of medical equipment—including CT, MRI, and robotic surgery systems—partnered with third-party reviewers to accelerate Class III imaging system approvals.

Microlife, renowned for its medical diagnostic devices such as blood pressure monitors and digital thermometers, upgraded its post-market surveillance processes to meet the TFDA’s new vigilance standards, supporting global compliance.

DELBio, a subsidiary of Delta Electronics, integrated FDA and EU MDR documentation into TFDA filings for blood glucose meters and oximeters, significantly reducing review times.

These targeted adaptations not only benefit individual companies but also set a clear model that will benefit all Taiwanese medical device manufacturers seeking global growth.