When entering the medical device market in Taiwan, one of the most important regulatory steps is determining the correct classification of your product. Taiwan classifies medical devices into three categories based on risk level, and each class comes with specific requirements for licensing and quality documentation.
Here’s a simplified breakdown to help navigate the basics:

Three Classes of Medical Devices
Taiwan’s medical device regulatory system classifies products into Class I, Class II, and Class III:

• Class I: Low-risk medical devices
• Class II: Medium-risk medical devices
• Class III: High-risk medical devices

The higher the risk level, the more rigorous the regulatory process and supporting documentation required.

Class I Devices: Select Exemptions from QSD
There are more than 600 scopes classified under Class I in Taiwan. However, only 125 specific Class I device scopes, when non-sterile, are exempt from requiring a Quality System Documentation (QSD) approval.
To summarize:

• Non-sterile Class I devices:
  • If they fall within the list of the 125 exempted types → QSD not required
  • If not in the exempted list → QSD required
• Sterile Class I devices:
  • Always require QSD

This makes some Class I devices relatively easier to register, but it’s essential to confirm whether your device type is on the exemption list.

Device Classification by Type and Scope
Taiwan categorizes medical devices into 16 major types, labeled A through P, which roughly correspond to the U.S. FDA’s CFR Title 21 regulatory framework.
Each major category contains multiple product scopes, each assigned a unique four-digit code.
For example:

• Type A = Clinical Chemistry and Clinical Toxicology Devices
• Scope A.0001 = Phencyclidine test system

While many of these scopes align closely with U.S. FDA definitions, there are differences. Each device must be reviewed under Taiwan's regulatory definitions.


What Is Considered a "New" Medical Device in Taiwan?
A medical device may be classified as “new” in Taiwan if it involves:

• New principles
• New structure
• New materials
• New functions or efficacy
• No existing similar products on the market

New medical devices are subject to a more comprehensive review process and may require additional testing or clinical evidence.

Final Thoughts
Understanding how your product fits into Taiwan’s medical device classification system is essential to preparing the right documentation and planning your market entry timeline. Whether your product falls under Class I, II, or III—or is considered a “new” device—accurate classification can significantly affect the speed and complexity of the approval process.
When in doubt, consult with a regulatory expert or local agent to ensure your registration strategy is aligned with the latest requirements from the Taiwan Food and Drug Administration (TFDA).

When it comes to registering medical devices in Taiwan, one critical component is obtaining a Quality System Documentation (QSD). QSD serves as a paper-based evaluation and acts as a substitute for onsite audits. The Taiwan Food and Drug Administration (TFDA) issues QMS certificates for domestic manufacturing sites, while QSD certificates are issued for overseas manufacturing sites.
 
What is QSD and Why is it Important?
QSD stands for Quality System Documentation, which is a necessary step for most medical device licenses. According to Taiwan’s Medical Device Management Act, Article 22, medical device manufacturers must establish and maintain a quality management system that encompasses facilities, equipment, personnel, production, quality control, storage, distribution, customer complaints, and other regulatory matters. The system must meet established guidelines, and once compliance is confirmed, manufacturers can apply for a production permit.
Manufacturers based outside of Taiwan are required to submit a QSD as part of the registration process.
 
QSD is a Prerequisites for Most Medical Device Registration
Except for some low-risk, non-sterile medical devices, QSD is a mandatory requirement for obtaining a medical device license in Taiwan. While QSD and license applications can be submitted simultaneously, approval for QSD is required before the TFDA can grant the license approval.
For a list of medical devices that do not require QSD, please refer to the TFDA’s guidelines here: TFDA QSD Exemption List.
 
QSD Reviewing Process
QSD certificates are valid for three years, and the renewal process mirrors the initial application process in terms of cost and duration. Typically, QSD renewal takes about 6-9 months to process. It is crucial to initiate the renewal process six months to one year before the expiration date to ensure there’s no disruption in your certification status. If the renewal is approved before the expiry date, the new expiry date will be three years from the original expiry date.
Since QSD is designed to replace on-site audits, renewing a QSD is essentially treated as applying for a new QSD. You should anticipate the same time, cost, and effort for the renewal process.
If your manufacturing site moves or if you need additional scopes covered, the amount of time and work is similar to those needed to register a new QSD. We recommend registering all the scopes you might need in the next three years.
 
Types of QSD
There are three types of QSD, each with its own set of requirements:

• Standard Mode: The most comprehensive option for manufacturers.
• Abbreviated Mode: Available for manufacturing sites in the US, EU, and Japan that meet the respective requirements.
  • EU Technical Cooperation Program (EU TCP): Includes plants in Switzerland and Liechtenstein.
• Essential Mode: This mode is limited to specific scopes outlined in Article 78 of Taiwan’s Medical Device Quality Management System Regulations. It requires fewer Standard Operating Procedures (SOPs) than the Standard Mode.

Each QSD type is tailored to specific manufacturing requirements and regions.
More information can be found at Required Documents for QSD.
 
Scope and Manufacturing Site Specificity
QSD is manufacturing site-specific and scope-specific. The QSD approval will list the approved activities for each manufacturing site. These activities may include:

• Design
• Manufacture
• Labeling/Packaging
• Sterilization
• Final Release

It's important to note that QSD must be tailored to your specific manufacturing site and the scope, with the specific activities of each scope listed.
 
Parallel Review Benefit and Risk
QSD approval is a prerequisite for most medical device licenses in Taiwan. The TFDA allows parallel review of QSD and license applications. However, QSD approval must be obtained before the license can be granted.
Both QSD and license applications are allowed one chance for deficiency response and one chance for appeal. Therefore, if QSD fails in the later stages, the risk of the license application being rejected is high. It’s crucial to address any deficiencies early in the process.
 
Using Another Company’s QSD
If a company in Taiwan already holds a valid QSD that meets all your needs (the same manufacturing site, scope, and activities), you can use their QSD for license registration. However, both the QSD holder and the manufacturing site must authorize this. The authorization can be revoked at any time by either party.
 
QSD: A Time-Consuming Process
QSD certification is a detailed and time-consuming process. Given its importance, we recommend planning ahead and allocating sufficient time and resources for the QSD application or renewal process.
At Wonderville, we understand the complexities of obtaining QSD approval, and we are here to help guide you through every step. Contact us today for a free quotation on your QSD needs.
 
Conclusion
QSD is a vital component of the medical device registration process in Taiwan. Whether you are applying for a new QSD or renewing an existing one, it is essential to understand the requirements and timelines involved. Remember, QSD approval is necessary before a medical device license can be granted, so staying ahead of the renewal process is key to ensuring compliance.
For more information or to begin the QSD process, reach out to Wonderville. We’re here to help you navigate this essential regulatory step with confidence.