Regulation of Software as a Medical Device in Taiwan

Introduction

Software as a Medical Device (SaMD) is an evolving sector within the medical device industry, providing essential tools for healthcare applications such as diagnostics, treatment planning, patient monitoring, and telemedicine. Taiwan’s regulatory framework for SaMD is overseen by the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare (MOHW). The TFDA is responsible for ensuring that all medical software products that fall within its jurisdiction meet stringent safety, quality, and effectiveness standards before they are allowed to enter the market. This article provides a comprehensive overview of Taiwan’s regulatory landscape for SaMD, covering its definition, classification, registration process, and regulatory requirements.

Definition of Medical Device Software

According to Taiwan’s “Guidelines for Classification of Medical Software,” medical device software refers to applications that collect, store, analyze, display, and convert health-related data for use in medical institutions, personal home care, and remote healthcare services. The software must be designed with a medical purpose in mind and should contribute to the diagnosis, treatment, or management of a patient’s health condition.

It is important to note that not all medical software is classified as a medical device. Determining whether software falls under this category requires an assessment based on several key factors. These factors include the software’s function, intended purpose, method of use, and potential risks to patient safety. Specifically, regulatory authorities assess whether the software:

Complies with Article 3 of the Medical Device Act – This involves determining if the software meets the definition of a medical device under Taiwanese law.
Is Listed in the Regulations Governing the Classification of Medical Devices – If the software appears in the regulatory classification list, it will be subject to specific requirements.
Has Diagnostic or Therapeutic Functions – Software that plays a role in diagnosing or treating diseases is more likely to be regulated.
Is Critical to Disease Treatment – The extent to which the software contributes to treating a disease is a significant consideration.
Aids in Disease Diagnosis – Software that provides clinical decision support or assists medical professionals in diagnosing conditions may be subject to regulation.
Poses a Risk to Human Health – If the software has the potential to cause harm to patients or interfere with medical decision-making, it will likely be classified as a medical device.

Regulatory Classification of Medical Device Software

SaMD products in Taiwan are classified into different categories based on their function, intended use, and potential risk level. The classification system ensures that software is appropriately regulated according to its complexity and impact on patient health. The four primary categories of medical device software include:

Accessories for Medical Equipment – This category includes software that is integrated into a medical device to control its operation or enhance its functionality. Examples include software used to control diagnostic imaging machines, infusion pumps, or patient monitoring systems.
Stand-alone Software – This type of software is independent of a specific medical device and is often used to process and analyze medical data. It may include applications that assist healthcare professionals in interpreting diagnostic test results.
Mobile Applications (Apps) – These are software applications that can be installed on mobile devices such as smartphones, tablets, or wearable gadgets. If the app is designed for medical purposes, such as monitoring blood glucose levels for diabetic patients, it will be subject to medical device regulations.
Recording Media – This includes software that is stored on physical media such as CDs, SD cards, or USB drives. Software that is downloaded from the internet and meets the definition of a medical device is also subject to regulation.

Examples of SaMD Classification

To further clarify the classification of SaMD, the TFDA has provided examples of how different types of software are categorized based on their function and level of risk:

Class I Medical Device: Software that primarily transmits, stores, or displays medical images without making any modifications to the data. An example is a basic X-ray image viewer that does not alter or analyze the image.
Class II Medical Device: This includes software with more advanced capabilities, such as medical image processing tools, computer-assisted detection (CADe) systems, and surgical treatment planning software. These programs assist healthcare professionals in analyzing medical data but do not replace human decision-making.
Class III Medical Device: This category includes software that claims to replace professional medical judgment by making autonomous disease diagnoses or treatment recommendations. Artificial intelligence (AI)-based diagnostic tools that function independently without human oversight fall under this category.

Regulatory Process for SaMD Registration

The TFDA has established a structured regulatory process that companies must follow before marketing their SaMD products in Taiwan. This process includes two key steps:

Quality System Documentation (QSD) Registration

Manufacturers of Class II and III medical devices, as well as some Class I devices, must establish a Quality Management System (QMS) that complies with TFDA regulations. The QSD registration process ensures that medical device manufacturers follow rigorous quality control measures throughout their production process. To obtain QSD approval, manufacturers must submit the following documentation:

Basic manufacturer information and a signed authorization letter
A valid ISO 13485 certification
A detailed quality manual and quality system procedures (waived for manufacturers from the U.S., EU, and Japan with equivalent certifications)
A list of manufacturing and testing equipment
Production process diagrams outlining the steps involved in device manufacturing

Product Registration

In addition to obtaining QSD approval, manufacturers must complete a separate product registration process. This step involves submitting:

A registration application and authorization letter
Product labeling, packaging insert, and carton labeling drafts
A Free Sales Certificate (FSC) from the country of origin, issued within the last two years
Preclinical and quality control test reports
Documentation detailing the product’s structure, specifications, and intended use
Clinical evidence, if requested by the TFDA
Radiation safety information for relevant devices
Essential Principles (EP) of safety and performance for Class III devices

Priority Review for SaMD

The TFDA provides a priority review pathway for Software as a Medical Device (SaMD) products that address urgent and critical medical needs. This expedited review process is designed to ensure that innovative and essential medical software can reach the market faster while maintaining rigorous safety and efficacy standards.

To qualify for priority review, the SaMD product must meet specific criteria outlined by the TFDA. Firstly, priority review is available for software that is specifically developed to treat life-threatening diseases for which no alternative treatments currently exist. These products must demonstrate that they offer a unique and essential solution in the medical field.

Secondly, software intended for the diagnosis or management of rare diseases, as defined by the Rare Disease and Orphan Drug Act, may also be eligible for priority review. Given the limited availability of treatment options for rare diseases, the TFDA aims to facilitate the availability of SaMD that can aid in early detection, monitoring, and management of these conditions.

Finally, priority review is granted to SaMD products that have received government research funding and are undergoing or planning to conduct clinical trials within Taiwan. This provision is aimed at encouraging local innovation and ensuring that domestically developed medical software can quickly transition from research and development to clinical use.

By offering a priority review process, the TFDA seeks to balance the need for timely access to advanced medical technologies with stringent regulatory oversight. This approach supports the development of high-quality medical software that meets international safety and performance standards while addressing critical healthcare needs in Taiwan.

Post-market Change Applications

In March 2022, the Taiwan Food and Drug Administration (TFDA) issued guidelines for post-market change applications related to Software as a Medical Device (SaMD). These guidelines help manufacturers assess whether modifications require regulatory approval to maintain compliance with safety and performance standards.

Changes that do not require approval include minor bug fixes, security patches, interface design updates, and upgrades to peripheral hardware such as keyboards or monitors, as long as these do not impact the software’s intended use or functionality.

However, approval is required for significant modifications that could affect performance, compatibility, or clinical outcomes. Examples include altering the core algorithm, changing the intended use, adding new diagnostic or analytical functions, upgrading to a non-backward-compatible operating system, or restructuring key software components such as databases and middleware.

By clarifying these requirements, the TFDA ensures that SaMD products continue to meet safety and efficacy standards while allowing for necessary technological advancements.

Conclusion

Taiwan’s regulatory framework for SaMD ensures that all software-based medical devices meet stringent safety, effectiveness, and quality requirements. Companies seeking market entry must carefully navigate the TFDA’s classification and approval process, establish a robust quality management system, and provide comprehensive documentation. The priority review pathway offers an expedited process for innovative medical software, while clear classification guidelines help distinguish between regulated and non-regulated products. As the field of SaMD continues to advance, Taiwan’s regulatory policies will likely evolve to accommodate new technologies, including artificial intelligence, telemedicine, and digital health applications. The integration of emerging technologies into medical software highlights the importance of continuous regulatory updates to maintain safety and efficacy standards while fostering innovation in the healthcare sector.

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.