+Medical device
​  product registration

TFDA

product inspection registration

Enhance the product value and company image of Taiwanese medical device manufacturers, and is an important certification for channel sales.

Taiwan’s requirements for medical devices are clearly stipulated in Article 29 of the Medical Device Management Act, which stipulates that medical device product registration should be applied for or registered in accordance with Article 25; Article 26 applies for change inspection; Article 27 applies for extension. Medical device vendors that have passed QMS/QSD inspection must apply for inspection registration in accordance with the medical device license issuance and registration and annual declaration guidelines before selling medical devices.

MedServ provides registration solutions for countries outside of Taiwan, including product registration consultation for medical device manufacturers/importers in the United States, China, the European Union, and Southeast Asian countries. Welcome to contact us at any time.

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QSD

​Quality System Documentation

Application for review of quality system documents of foreign medical device manufacturers

Enhance the product value and company image of medical device sellers, and is an important certification for sales in Taiwan.

In order to meet the complete needs of medical device importers, MedServ can provide direct communication with foreign original manufacturers, prepare the required documents for application, and assist with supplemental documents to ensure the value of complete medical device safety and effectiveness.

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MedServ provides comprehensive QSD applications for medical device sellers, including initial, follow-up, and change applications. You are welcome to consult at any time.