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Navigate Your Path to Success in Taiwan Medical Device Market

K&C Associates is your gateway to success in the Taiwan medical device market. With over 18 years of experience, we will help you navigate complex regulations and unlock the potential of this dynamic market.


K&C Associates, the first regulatory consulting firm in Taiwan to be GDP-certified, has assisted more than 350 companies with over 2500 registrations. We also offer additional medical regulatory services upon request.

We aid manufacturers in the initial classification of their medical devices, gathering all necessary registration materials, and submitting them in a
professional manner.

We provide assistance to foreign manufacturers in obtaining QSD certification to ensure compliance with industry standards.

We offer regulatory strategic planning services based on our extensive understanding of the TFDA regulatory system.

We assist domestic distributors in setting up a quality management system that meets the standards required to obtain a GDP certificate.

We serve as your liaison with regulatory authorities and assist with product registration, vigilance, and reporting adverse events.

We assist in applying for NHIA reimbursement and help you secure a higher price than the reimbursement amount.

Why Choose Us?


Obtained more than 100 TFDA registrations for “New Medical Device”


Obtained more than 60 TFDA registrations for “High-Risk 
Medical Devices”


Obtained more than 400 Class III medical device registrations


Obtained more than 1700 Class II medical device registrations


Completed more than 800
QSD registration /license renewal

Solid Experience

Having over 18 years of experience, we have managed to fulfill the needs of over 350 clients and have effectively registered over 2500 medical devices.

Expert Representative

Our group of experts will assist you in navigating through all the stages involved in TFDA registration procedures and rules.

Post-market Support

We provide assistance with post-market surveillance, which involves reporting Serious Adverse Events (SAEs) and device recalls as needed.

Regulatory Radar

Our team will keep you updated on any potential regulatory changes in Taiwan that may affect your devices.


We protect your intellectual property and ensure your business interests are safeguarded.

Global Perspective

Our global perspective enables us to create effective strategies that meet the diverse needs of our foreign clients.



Regulation Update | Announcement on Electronic Instructions Replacing Traditional Chinese Instructions for Medical Devices


How to introduce your medical devices to Taiwan?


10F., No.221, Sec. 3, Beixin Rd.
Xindian District, New Taipei City

231 Taiwan

+886 2 29108777

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