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).