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In-Country
Regulatory
Representative
To register, hold, and manage medical device registrations and post-market responsibilities in Taiwan, applicants must meet TFDA's regulatory requirements, including local company registration, physical office location, and sales licenses.
Choosing us as your local regulatory representative is a highly efficient and low-risk solution.
Our Taiwan Agents will Help You:
Submit registration documentation
to TFDA on
your behalf
Help obtain
Quality System Documentation (QSD) Certificate
Act as regulatory liaison with TFDA
Manage Serious Adverse Event reporting
for device
Assist with maintenance of QSD certificate and device registration
Authorize Taiwan distributors to import products directly from manufacturer
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