Overview

Taiwan has a growing demand for Medical Devices. The Taiwan Food & Drug Administration (TFDA) under Ministry of Health and Welfare (MOHW) regulates Medical Devices through Pharmaceutical Affairs Act (PAA). The agency classifies the devices into 3 classes based on risk. Class-I for low-risk, Class II for moderate-risk and Class III for high-risk devices. The need for a predicate device to market poses challenge for novel devices to enter the market. Increased procedural time gap for Class II and III devices needing Quality System Documentation is another complexity involved.

Freyr specializes in catering to Regulatory needs of Medical Devices in Taiwan. With extensive network, Freyr helps in appointing a reliable local agent whose presence is of utmost importance throughout the post-marketing surveillance. Our experts also assist in selection of suitable predicate device and existing approvals from other markets to support new device market entry.

 

Taiwan Market Entry for Medical Devices - Process Flow

Taiwan Medical Device Regulations

 

 

Freyr Expertise

  • Regulatory Support in Registration Process
  • Medical Device Classification
  • Taiwan Local Authorized Representation
  • Regulatory Assistance for Quality System Documentation (QSD) Registration
  • Post-Market Surveillance

 

Summary

S. No

Regulatory Parameter

Taiwan

1

Regulatory Authority

TFDA

2

Regulation

Pharmaceutical Affairs Act (PAA)

3

Risk Classification

Class I

Class II

Class III

4

Regulatory Pathway

Class I

Product Registration

Class II & III

QSD + Product Registration

5

Authorized Representative

Taiwan Agent required

6

Fee payable

Class I

~ $ 350*

Class II

~ $ 860*

Class III

~ $ 1310*

QSD

~ $ 1310*

7

QMS Requirement

Quality System Documentation (QSD)

ISO 13485

8

Assessment of Technical Data

Division of Medical Devices & Cosmetics

9

Validity of License

QSD

3 Years

Product Registration

5 Years

10

Labelling Requirements

Article 75, Pharmaceutical Affairs Act

11

Submission format

Paper

12

Final Outcome

Medical device permit license.

13

Timelines

QSD

6 months

 

 

Product Registration

1 - 2 years

14

Language

English & Chinese

*This price is as per records at the time of documentation and is subject to change.