Taiwan Medical Devices Registration

TFDA Medical Devices Consultant to register QSD and products permit licenses. Prepare required documents and after-application follow-ups.

Send an email to tpe4ww.elr@evershinecpa.com
Director Jerry Chu, USA Graduate School Alumni, and a well-English speaker
Mobile: +886-939-357-735
Tel No.: +886-2-2717-0515 ext. 103

Service Scope:
Quality System Documentation (QSD) Registration to MOHW
A new application of medical device permit license to TFDA
Renewal application of medical device permit license to TFDA

Evershine acts as your regulatory affairs consultant on Medical Devices, to register QSD and products licenses. We help prepare registration documents and information and provide regulatory affairs feedback and support. Being assigned for the correspondence and related works with relevant parties, Evershine should keep the content of the product, the method of exemption, company managing affairs confidential, unless for the governmental requirement.

Below are Questions and Answers for your review.

Q:
In Taiwan which government are responsible for Medical Devices Regulatory and Registration?

A:
The Ministry of Health and Welfare (MOHW) and Under the MOHW, the Taiwan Food and Drug Administration (TFDA).
Please click https://www.fda.gov.tw/TC/site.aspx?sid=39 in Chinese

MOHW performs on-site inspection for local manufacturers and also reviews Quality System Documentation (QSD) provided by foreign manufacturers.

TFDA is Taiwan’s equivalent of the U.S. FDA. All imported medical devices must obtain a registration certificate from the TFDA.

Please click below two webpages in English:
https://www.fda.gov.tw/ENG/lawContent.aspx?cid=5063&id=1440

https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f637327573209171898

Q:
Do medical Devices need to be registered before being sold in Taiwan?
A:
Yes, medical devices do require registration before being sold in Taiwan.
please click https://www.fda.gov.tw/ENG/law.aspx?cid=5063 in English

Q:
How many different regulatory classifications of Medical Devices in Taiwan?

A:
Four Categories:

Class I Device: Low Risk
Class II Device: Moderate Risk
Class III Device: High Risk
PMA: New Medical Devices which are no devices approved by the TFDA. In other words, if there are no similar devices previously approved by the TFDA, your device will be considered a PMA device in Taiwan.

Q:
What are the application procedures of Medical Devices in Taiwan?

A:
First step: Quality System Documentation (QSD)

Please click https://www.fda.gov.tw/TC/site.aspx?sid=2215 in Chinese
Before a medical device can be sold in Taiwan, besides medical device registration, QSD registration for the manufacturing facility is required.
But Class I (non-sterile) medical devices can be waived for QSD registration. A QSD license (received upon QSD registration approval) in Taiwan, is similar to Good Manufacturing Practice (GMP) for medical devices.

Second Step: Product Registration Process

Please click https://www.fda.gov.tw/TC/siteContent.aspx?sid=1975 in Chineses
Before importation and sale of a medical device (Class I, II, III, or PMA) in Taiwan, the device needs to be registered and approved by the TFDA.
The TFDA issues a “medical device product license” upon product registration approval.

Class I
- Class I medical devices without brand names (e.g. surgical instruments or power accessories) usually follow a simple self-declaration process in Taiwan.
- Timeline: The Class I registration approval process takes about 3 months.
Class II and III
- TFDA 90 days- Approval or Notice for deficiency
- If Notice for deficiency, 90 days+30 days to answer deficiency
- After answering deficiency, 90 days approval or rejection
- If being rejected, within 120days to appeal
PMA Medical Devices
- TFDA 90 days- Approval or Notice for deficiency
- If Notice for deficiency, 90 days+30 days to answer deficiency
- After answering deficiency,- decision or sending to Committee Review within 120 days
- If sending to Committee, within 60days approval or rejection.
- If being rejected, within 120days to appeal

Q:
What are the required documents when applying for Medical Device Product Permit Licence?

Please click https://www.fda.gov.tw/TC/siteList.aspx?sid=2227 in Chinese

Class I Non-Sterile Medical Devices

Simple declaration form
Documents Required for QSD Registration
- Documents required for Standard Mode:
  1. Quality Manual
  2. Quality Procedures per sub-clauses of ISO 13485
  3. Manufacturing Flow Chart
  4. List of major equipment
  5. Plant layout
  6. QSD Statement
  7. NB Statement to confirm the scope claimed
- Documents required for Simplified Mode (for U.S.):
  1. Latest FDA EIR
  2. Certificate to Foreign Government (CFG)
  3. ISO 13485 Certificate
  4. QSD Statement
  5. NB Statement to confirm the scope claimed
- Documents required for Simplified Mode (for EU):
  1. A test audit report (NB = TCP member)
  2. Free Sales Certificate
  3. QSD Statement
  4. NB statement to confirm the scope
- Please note:
  for a non-sterile Class I medical device, no QSD registration is needed– but product registration is required.
- Class II & III Medical Devices

Since July 2013, Taiwan requires the Summary Technical Documentation (STED) format for submissions of technical documents for all Class II and III medical devices.

QSD registration certificate
CFG with product codes and description
Letter of authorization
Labeling (Brochure, IFU, label of each product group)
Product property
Pre-clinical test reports
For Class II medical devices, pre-clinical test reports can be waived when both U.S. CFG and EU free sale certificates are available.
PMA Medical Devices
- QSD registration certificate
- CFG with product codes and description
- Letter of authorization
- Labeling (Brochure, IFU, Label of each product group)
- Product property
- Pre-clinical test reports
- Clinical safety reports

Foreign clinical data can be accepted by TFDA? Is local testing (type testing /sample testing) required for TFDA registration?

Foreign clinical data from Western countries are generally accepted; however, in certain cases (especially for PMA devices), the TFDA may request local testing.

What scenarios of the clinical study will be necessary for registration?

Clinical data is required for all PMA devices and Class III IVD and DOH-designated medical devices.
Fortunately, foreign clinical data from Western countries are generally acceptable.

Are approval documents in the Country of Origin required for TFDA registration?

Yes, approval for the medical device in the Country of Origin is required for registration.

Contact Us

If you are interested in our services, please send an email to tpr2ww.elr@evershinecpa.com. We will respond to you in 1-2 working days.

You may also call in working hours (Taipei and China Time):
Director Jerry Chu, USA Graduate School Alumni and a well-English speaker
Mobile: +886-939-357-735
Tel No.: +886-2-2717-0515 ext. 103

Additional Information

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(version: 2024/07)

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