What is TFDA?
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Safety. Expertise. National-Level Certification.
The Taiwan Food and Drug Administration (TFDA) is the central government authority responsible for regulating the safety and quality of food, pharmaceuticals, medical devices, and cosmetics in Taiwan.
TFDA establishes regulations, reviews product approvals, monitors the market, and safeguards public health.
What is the QMS Conformity Assessment for Medical Devices?
Under the Medical Devices Act, certain medical device manufacturers in Taiwan are required to pass the TFDA's QMS Conformity Assessment, demonstrating that their quality management systems comply with international standards such as ISO 13485.
The assessment ensures strict and consistent quality control throughout the entire process — from product design and manufacturing to inspection and after-sales service.
Our Commitment
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In 2023, we completed TFDA's rigorous evaluation and received:
QMS Conformity Assessment CertificateApproval No.: QMS0264
This achievement shows that we go beyond compliance — we uphold a standard of excellence to protect every user with the highest level of safety and trust.
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Why It Matters
Quality Assurance: Indicates that our manufacturing process follows strict quality standards.
Regulatory Compliance: A key requirement for legal market approval of medical devices.
Building Trust: Reassures healthcare professionals and consumers about the safety of our products.
