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Medical Device, Diagnostics Regulations in Taiwan FDA - Frequently Asked Questions (FAQs)

Here are responses to some frequently asked questions (FAQs) regarding medical device and diagnostics regulations in Taiwan FDA:

 


taiwan medical device diagnostics regulations fda frequently asked questions consultant registration

What is the regulatory authority responsible for medical device and diagnostics registration in Taiwan?

The regulatory authority responsible for medical device registration in Taiwan is the Taiwan Food and Drug Administration (TFDA). The TFDA is a division of the Ministry of Health and Welfare (MOHW) of Taiwan. It is responsible for ensuring the safety, quality, and efficacy of medical devices in Taiwan.

 

What are the steps involved in the registration process of a medical device in Taiwan as per TFDA regulations?

 

  1. Determine the risk classification of your device. Medical devices are classified into four risk classes: Class I, Class II, Class III, and Class IV.

  2. Choose the evaluation route. There are two evaluation routes for medical device registration in Taiwan: Standard Mode and Simplified Mode.

  3. Prepare the registration dossier. The registration dossier is a collection of documents that demonstrate that your device meets the safety, quality, and efficacy requirements of the TFDA.

  4. Submit the registration application. The registration application can be submitted online through the TFDA’s Medical Device Registration System (MDRS).

  5. Review and approval of the application. The TFDA will review your application and make a decision on whether to register your device.

  6. Issuance of the registration certificate.

Are there any specific labeling or packaging requirements for medical devices in Taiwan as per TFDA regulations?

Yes, there are specific labeling and packaging requirements for medical devices in Taiwan as per TFDA regulations. The labeling and packaging requirements for medical devices in Taiwan are as follows:

 

  1. Language: All commodities sold in Taiwan shall be labeled using the Chinese language and may be supplemented by English or another foreign language, provided the Chinese labeling is no less comprehensive than the product label written in the language-of-origin.

  2. Product Information: Imports sold in Taiwan must be labeled with product information including the name of the commodity itself; the name, telephone number, and address of the producer or manufacturer; the commodity’s place of origin; and the name, telephone number, and address of the importer.

  3. Contents or Composition: Product labels must also include the contents or composition of the commodity; major components/ingredients, or materials; and the net weight, volume or quantity, and measurements of the product. This content information must be labeled in Chinese and use metric units.

  4. Hazardous or Dangerous Products: If a product is hazardous or dangerous in nature, is related to health and safety, has special characteristics, requires special handling, or has a limited storage duration, it must also be labeled with the date of manufacture in Chinese using either the Taiwan or Gregorian calendar, the expiration date or the term of validity, and other particulars as required by the Taiwan authorities.

  5. Medical Device Specifics: The labeling must include the following information: The name and address of the manufacturer, packer, or distributor; the trade or brand name of the device; the unique device identifier (UDI).

  6. Class II, Class III, and IVD Medical Devices: For these classes of medical devices, general labeling requirements include: Product specifications, including technical parameters and performance characteristics; detailed instructions for use and any necessary precautions or warnings; identification of the product as a medical device; usage limitations and contraindications.

 

What is the role of local representative for medical device and diagnostics registration in Taiwan?

The Local Authorized Representative (LAR) plays a crucial role in the medical device registration process in Taiwan. Here are some of their responsibilities:

  1. Representation: The LAR is a company or individual appointed by the foreign manufacturer to represent them in Taiwan1.

  2. Registration Application: The LAR is responsible for submitting the registration application to the Taiwan Food and Drug Administration (TFDA).

  3. Communication with TFDA: The LAR interacts with the TFDA on behalf of the manufacturer1.

  4. Holding the Registration License: Once the product has been approved by the TFDA, the LAR holds the medical device registration, known as a Registration License.

  5. Filing Import Authorization Requests: The LAR is also responsible for filing the required Import Authorization requests to the TFDA for each distributor.

These responsibilities make the LAR a key player in the process of medical device registration in Taiwan. It’s important to choose a reliable and experienced LAR when planning to register a medical device in Taiwan.

 

Does Taiwan FDA accept CE marking approval as reference for medical device and diagnostics registration?

The Taiwan Food and Drug Administration (TFDA) has its own regulatory approval process for medical devices, which is independent of the CE marking approval process used in the European Union1. The TFDA’s process involves determining the classification of the device, appointing a Taiwan Agent to manage the device registration, preparing a quality system documentation (QSD) application, and submitting a registration application/dossier to the TFDA.

 

While the TFDA does not directly accept CE marking approval as a reference for medical device registration, having a CE mark could potentially facilitate the process as it demonstrates that the device meets certain international standards. However, it’s important to note that the TFDA has its own specific requirements and standards that must be met for medical device registration.

 

Does Taiwan FDA accept US FDA approval as reference for medical device and diagnostics registration?

Yes, the Taiwan Food and Drug Administration (TFDA) does consider US FDA approval during the medical device registration process. For Class II medical devices that have approval in the US, manufacturers can usually use existing documentation in place of the preclinical test, quality control procedure, and test reports1. However, it’s important to note that this does not replace the need for TFDA approval. All imported medical devices must still obtain a registration certificate from the TFDA.

 

What are the timelines for review and approval of medical devices in Taiwan?

The review and approval timelines for medical devices in Taiwan vary depending on the class of the device:

  • Class I Medical Devices: The Taiwan Food and Drug Administration (TFDA) takes about 90 working days for the review of Class I medical device applications.

  • Class II and III Medical Devices: The review process for Class II and III medical devices takes about 180 working days.

Please note that these timelines are approximate and can vary based on the specifics of the device and the completeness of the application.

 

 

What are the fees and costs for registration of medical devices in Taiwan?

The fees and costs for registration of medical devices in Taiwan vary depending on the risk classification of the device and other factors. Here are some approximate costs:

 

Registration Application Fee: This fee varies depending on the risk classification of the device:

 

  • Class I: NT$3,000 (approximately US$97)

  • Class II: NT$6,000 (approximately US$194)

  • Class III: NT$12,000 (approximately US$388)

  • Class IV: NT$24,000 (approximately US$776)

  • Quality System Documentation (QSD) Registration: The fee for QSD registration is approximately $2,222, but for some low-risk, non-sterile Class I devices, it may be $1,1112.

  • Direct Import Authorization (DIA): The fee for DIA is approximately $1482.

  • New Devices (No predicate devices previously approved by the TFDA): The fee for these devices is approximately $4,8702.

 

Please note that these fees are subject to change based on the TFDA’s announcements and the exchange rate. For more detailed information, you may want to visit the official website of the Taiwan Food and Drug Administration or speak with Artixio Expert 

 

What are the challenges faced during registration of medical devices and diagnostics in Taiwan?

Registering medical devices in Taiwan can present several challenges:

  • Language Barriers: All documentation and communication with the Taiwan Food and Drug Administration (TFDA) must be in Chinese, which can be a challenge for non-Chinese speaking manufacturers.

  • Ever-Changing Regulations: The TFDA frequently updates its regulations, making it necessary for manufacturers to stay up-to-date with the latest changes.

  • Complex Bureaucratic Procedures: The registration process involves multiple steps, each with its own set of requirements and procedures.

  • Comparative Complexity: The complexity level of Taiwan’s medical device registration process is comparable to that of Japan’s and China’s registration processes, though somewhat simpler.

  • Time-Consuming Process: The registration process can take several months, so it is important to start the process early, especially if you are targeting a specific launch date.

  • Need for Local Representation: Foreign manufacturers must appoint a Local Authorized Representative (LAR) in Taiwan to manage the device registration.

  • Quality System Documentation (QSD) Registration: The QSD registration process can be complex and requires a thorough understanding of the TFDA’s requirements.


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