Strategic Regulatory Partner for Medical Devices
Expertise
Our Expertise
1
Product Registration Strategy
We provide end-to-end support for Taiwan medical device registration, including product classification, regulatory pathway assessment, and submission to Taiwan FDA. Our services cover new applications, license changes, and renewals to ensure full compliance throughout the product lifecycle.
2
QSD Certification & Manufacturing Compliance
We assist manufacturers in obtaining and maintaining Taiwan QSD certification for manufacturing sites. Our expertise includes submission strategy selection (standard, simplified, or essential), QMS documentation review, and efficient handling of scope changes and renewals.
3
Post-Market Compliance & Lifecycle Management
We support ongoing regulatory compliance in Taiwan through post-market activities, including adverse event reporting, recall management, and regulatory notifications. Additional services include UDI database maintenance, license transfer, and demo device applications.