ABOUT US
K&C Associates has more than 12 years of experience
We comprehensively assist with your business development and supervise all the aspects of
each project. We listen and communicate with clients closely. We protect your intellectual property. Assisted over 300 companies with registrations. Completed over 1500 registrations
Obtained TFDA registration for rare disease— the first and only — Orthopaedics Implants.
Focus
K&C Associates specializes in the field of TFDA medical device registration
with more than 12 years of experience
Obtained more than 200 Class III
medical device registrations.
Obtained more than 800 Class II
medical device registrations.
Obtained more than 500 QSD Certificates.
Obtained more than 30 TFDA registrations for “New Medical Device”.
Obtained more than 40 TFDA registrations for “High-Risk Medical Device”.
We help you successfully enter the Taiwan market faster
WHAT WE DO
QMS Compliance
Implementation and internal auditing for ISO 13485, FDA QSR and more.
Medical Device Registration
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Assist you classifying your device correctly to ensure a smooth registration process
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Compile the required documentation for registration application and design TFDA submission dossier
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Submit application documents and communicate with TFDA on your behalf
Regulatory Consulting
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Determine the most effective and
efficient regulatory strategy -
Regulatory strategic planning by using our strong understanding of TFDA regulatory system
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Medical device post market surveillance
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Risk consulting
In-Country Representative
Taiwan Food and Drug Administration (TFDA) requires that any medical device manufacturer with no legal entity in Taiwan has to appoint an
In-Country Representative.
Our In-Country Representative service will help you:
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Submit all registration documentation to TFDA on your behalf
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Assist in obtaining Quality System Documentation (QSD) Certificate
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Serve as a regulatory liaison between you
and TFDA -
Oversee Serious Adverse Event reporting for your device
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Assist in maintaining QSD certificate and
device registration -
Authorize your Taiwan distributor to import product from manufacturer directly
Reimbursement
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Apply reimbursement from
Bureau of National Health Insurance (BNHI) -
Procure a higher reimbursement price
Distributor Research
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Evaluate medical device distributors according to your requirements
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Identify and qualify potential medical
device distributors
CONTACT US
10F., No.221, Sec. 3, Beixin Rd.
Xindian District
New Taipei City, 231 Taiwan
+886 2 29108777