Taiwan Medical Device Consulting

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

Assist you classifying your device correctly to ensure a smooth registration process
Compile the required documentation for registration application and design TFDA submission dossier
Submit application documents and communicate with TFDA on your behalf

Regulatory Consulting

Determine the most effective and
efficient regulatory strategy
Regulatory strategic planning by using our strong understanding of TFDA regulatory system
Medical device post market surveillance
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: