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Services

Medical Device 
Registration
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Medical devices are classified based on their level of risk.

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Why Choose Us?

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  • We help classify your medical device for smooth registration.

  • We compile necessary documentation for registration and TFDA submission.

  • Our team keeps up-to-date on regulations and industry standards.

  • Our expertise navigates complex regulatory compliance and registration requirements.

  • We develop effective strategies tailored to your needs for timely regulatory clearance.

In Taiwan, medical devices require approval from the Taiwan Food and Drug Administration (TFDA) prior to commercialization, and the legal framework of the regulatory system is based on the Medical Device Act.

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What is a Medical Device?
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​According to the Medical Device Act Article 3, medical devices shall refer to instruments, machines, apparatus, materials, software, reagents for in vitro use, and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by other than pharmacological, immunological, metabolic, or chemical means:
1. Diagnosis, treatment, alleviation, or direct prevention of
human diseases.
2. Modification or improvement of the structure and function of human body.
3. Control of conception.

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Classification
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According to Regulations Governing the Classification of Medical Devices Article 2 of TFDA, medical devices are classified into categories according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty.

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Review Process for Device Registration in Taiwan​
Initial Submission
(a)
Appeal
A response is required within 4 months
TFDA Review Feedback
A response is required within 3 months
Committee Review
A response is required within 2 months
(b) not approved
(b) new device
(b) approved
(b) approved
License Granting
(c) approval
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TFDA Review Timeline​:
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  • Class I: (a) 1-2 months; (b) 1-2 month(s); Total 4-6 months

  • Class II: (a) 2-3 months; (b) 2-3 months; Total 8-10 months

  • Class III: (a) 3-4 months; (b) 3-4 months; Total 10-12 months

  • New Device: (a) 2-3 months; (b) 1-2 months; (c) 3-4 months; Total 18-24 months

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