Taiwan FDA


Taiwan Medical Device Registration

Medical device sector is one of the fastest growing market sectors in Taiwan with the industry maintaining double-digit growth for over a decade. Hence, it presents excellent opportunities for foreign exporters of medical equipment and supplies. Qualtech is your ideal partner to for your foray into the Taiwan medical device market for an easy and smooth registration process.

Qualtech in Taiwan

Pass Several GCP Inspections

Taiwan implements Good Clinical Practice from 2010. Qualtech has assisted many clinical sites to pass GCP inspection to ensure clinical performance

Get Over 3000 Approvals

Qualtech Taipei team is composed of 90% Master and PhD. With high-qualitied and experienced team, we assists clients to get Taipei approval in efficiency!

 

 

QT Services
 
 
 
 

Medical Device Registration

With than a decade’s experience in compiling successful TFDA submission dossiers, our in-house experts are able to provide you excellent professional service in preparing customized dossier and complying with evaluators’ queries for medical device registration in Taipei.

 
 

License Holder

With changing and strict environment in Taipei, it’s important to find a stable and professional local agent to assist you manage Taiwan market. Qualtech owns an excellent license holder system to support you easily manage the post-market surveillance, reimbursement, regulation compliance, license renewal and other license-related works.

 
 

Clinical Trial & CER Writing

There are two options for clinical evidence to TFDA: Conducting clinical trial or submitting CER complied with TFDA regulation. Qualtech has PhD leaded medical writing group, and an independent clinical trial team. Our experienced registration in medical device can ensure your clinical evidence meet TFDA’s requirement.

Overview of Taiwan Regulation

The registration of imported medical device in Taiwan is a two-stage process. The process, which is highly regulated by the Taiwan Food and Drug Administration (TFDA). The 1st stage is applying for QSD license for each manufacturer, and the 2nd stage is applying for foreign medical device registration. Foreign manufacturers must appoint an in-country License Holder (or local representative) to manage regulatory work of registered device, furthermore, the license holder has capacity to authorize designated importer/distributor to process the market related activities, such as importation, reimbursement, bidding... and such like stuff.

 

Classification
 
 

 

Class 1

Low risk

Product Listing

On-counter submission

Class 2

Moderate risk

Product Certificate

On-counter submission

Class 3

Hish risk

Product Certificate

On-counter submission

 

TECHNICAL REQUIREMENTS

Qualtech Class 1 Class 2 Class 3
Product History and Iteration   Yes Yes
Product Description (If any) Yes Yes
Predicate Product and Comparison Table   Yes Yes
Product Performance and Safety Report (If any) Yes Yes
Manufacturing information (If any) Yes Yes
Risk analysis (If any) Yes Yes
Clinical evidence   Yes Yes
User Manual Yes Yes Yes

Note: Kindly see the Regulation for Registration of Medical Devices issued in 2017 for more details.

Workflow

FDA Target Reviewing Turnaround Time

After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the FDA and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration/notification.

  CLASS 1 CLASS 2 CLASS 3
QSD application If any 6-8 Months 8-10 Months
Registration Evaluation 1 day 2.5 Months*1 3.5 Months*1
1st Compliance NA 2 Months*2 2 Months*2
2nd Compliance NA 4 Months 4 Months
  • Note:
  1. 1. De Novo device or high risk device might undergo TFDA advisory committee. TFDA has ability to prolong the evaluation turnaround time once this application is required TFDA advisory committee.
  2. 2. The registrant can apply for another 1 month of extension if they cannot submit the compliance in time.

 

Validity
  • Types of Certificates: QSD Certificate, Product listing, Product Certificate

  • QSD Certificate: 3 years.

  • Product listing: Permanent once Medical Devices Act is effective

  • Product Certificate: 5 years

 

Tips
What is QSD? Should I apply for it?

Quality System Documentation (QSD) is part of TFDA’s Good Manufacturing Practice, the implementation of this system is to ensure the quality of manufacturers before registering their products.

Under TFDA regulation, Class 1 products without measuring function and sterilization do not require QSD, beside that, QSD is essential for all other products including Class 2&3. For QSD application, TFDA recognizes manufacturers in the US, Puerto Rico, Guam, and manufacturers from European Union countries and limited to EU Notified Bodies which participate in the “Technical Cooperation Program on Exchange of Audit Reports between EU and Taiwan (TCP)” via abbreviated mode with shortened timeline, enabling faster market access. Other than the above regions, the application needs to follow full-application mode.

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For more information, please refer to the Taiwan FDA’s official website or you may contact us for a free consultation.

 
Official Website
 
 

 

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