Here are answers to some of the Frequently Asked Questions (FAQs) about Taiwa regulations for Medical Device registration.
What is the regulatory authority responsible for medical device 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 medical device in Taiwan as per TFDA regulations?
The registration process of medical devices in Taiwan as per TFDA regulations is as follows:
Determine the risk classification of your device. Medical devices are classified into four risk classes: Class I, Class II, Class III, and Class IV. The risk classification of your device will determine the evaluation route and the documentation requirements for registration.
Choose the evaluation route. There are two evaluation routes for medical device registration in Taiwan: Standard Mode and Simplified Mode. The evaluation route that you choose will depend on the risk classification of your device, the availability of clinical data, and the prior approvals received from overseas regulatory agencies.
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. The contents of the registration dossier will vary depending on the evaluation route that you choose.
Submit the registration application. The registration application can be submitted online through the TFDA's Medical Device Registration System (MDRS). The application fee will vary depending on the risk classification of your device.
Review and approval of the application. The TFDA will review your application and make a decision on whether to register your device. The review process can take several months.
Issuance of the registration certificate. If your device is registered, you will be issued a registration certificate. You will need to display this certificate on your device and on all marketing materials for your device.
Here are some additional tips for registering a medical device in Taiwan:
Start the registration process early. 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.
Work with a qualified consultant. A qualified consultant can help you navigate the registration process and ensure that your application is compliant with TFDA requirements.
Keep the TFDA updated. If there are any changes to your device or your manufacturing process, you will need to notify the TFDA.
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. These requirements are designed to ensure that medical devices are properly labeled and packaged so that they can be used safely and effectively.
The labeling requirements for medical devices in Taiwan are set out in the Medical Device Labeling Regulation. 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)
The intended use of the device
The instructions for use
Any warnings or precautions
The expiry date (if applicable)
The batch or lot number
The packaging requirements for medical devices in Taiwan are set out in the Medical Device Packaging Regulation. The packaging must be designed to protect the device from damage and to ensure that it is used safely and effectively. The packaging must also 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)
The intended use of the device
The instructions for use
Any warnings or precautions
The expiry date (if applicable)
The batch or lot number
In addition to the labeling and packaging requirements, medical devices in Taiwan must also comply with the following requirements:
The device must be manufactured in accordance with Good Manufacturing Practices (GMP)
The device must be subjected to appropriate clinical trials
The device must be accompanied by a Declaration of Conformity (DoC)
For more information on the labeling and packaging requirements for medical devices in Taiwan, please refer to the following TFDA regulations:
Are clinical trials or testing necessary for registration of medical devices in Taiwan? If so, what are the TFDA requirements?
Clinical trials or testing are not mandatory for registration of medical devices in Taiwan. However, clinical trials or testing may be required depending on the risk classification of the device and the availability of clinical data.
For Class I devices, clinical trials or testing are not required. However, the manufacturer must provide a risk management file (RMF) that demonstrates that the device is safe and effective.
For Class II devices, clinical trials or testing may be required depending on the intended use of the device. If clinical trials or testing are not required, the manufacturer must provide a RMF and other supporting documentation that demonstrates the safety and effectiveness of the device.
For Class III and Class IV devices, clinical trials or testing are required. The manufacturer must submit a clinical evaluation report (CER) that summarizes the results of the clinical trials or testing. The CER must demonstrate that the device is safe and effective for its intended use.
The TFDA has published a guidance document on the clinical evaluation of medical devices in Taiwan. This document provides more information on the clinical trial requirements for different risk classes of devices.
The TFDA also has a list of approved clinical trial sites in Taiwan.
Here is a list of some of the approved clinical trial sites in Taiwan (the list may be updated time to time, please refer to TFDA website for current information):
National Taiwan University Hospital (NTUH)
Taipei Medical University Hospital (TMU)
Chang Gung Memorial Hospital (CGMH)
Mackay Memorial Hospital (MKH)
Taichung Veterans General Hospital (TVGH)
Kaohsiung Medical University Hospital (KMUH)
National Cheng Kung University Hospital (NCKUH)
Taipei Veterans General Hospital (TVGH)
What are the fees associated with the medical devices registration process in Taiwan as per TFDA regulations?
The fees associated with the medical devices registration process in Taiwan as per TFDA regulations are as follows:
Registration application fee: The registration application fee for medical devices in Taiwan varies depending on the risk classification of the device.
Class I: NT$3,000 (US$97)
Class II: NT$6,000 (US$194)
Class III: NT$12,000 (US$388)
Class IV: NT$24,000 (US$776)
Priority review fee: The priority review fee is available for Class II and Class III devices. The priority review fee expedites the review process by 1-2 months.
Class II: NT$15,000 (US$521)
Class III: NT$30,000 (US$1,042)
Annual retention fee: The annual retention fee is required for all registered medical devices in Taiwan. The annual retention fee varies depending on the risk classification of the device.
Class I: NT$1,000 (US$32)
Class II: NT$2,000 (US$64)
Class III: NT$4,000 (US$128)
Class IV: NT$8,000 (US$256)
The fees are subject to change, so it is always best to check the TFDA website for the most up-to-date information.
In addition to the fees, there may be other costs associated with the medical devices registration process in Taiwan, such as the cost of preparing the registration dossier and the cost of clinical trials.
Is it necessary to have a local authorized representative in Taiwan for Medical Device registration?
Yes, it is necessary to have a local authorized representative (LAR) in Taiwan for medical device registration. The LAR is a company or individual that is appointed by the foreign manufacturer to represent them in Taiwan. The LAR is responsible for submitting the registration application to the TFDA, and for interacting with the TFDA on behalf of the manufacturer.
The LAR must be a company or individual that is registered with the TFDA and that has a valid dealer's license. The LAR must also have a qualified person responsible for regulatory affairs (QPR) who is familiar with the TFDA regulations for medical devices.
The LAR has a number of responsibilities, including:
Submitting the registration application to the TFDA
Responding to TFDA queries
Providing TFDA with updates on the device
Ensuring that the device is compliant with TFDA regulations
Dealing with any post-market issues
The LAR is an important part of the medical device registration process in Taiwan. By appointing a LAR, the foreign manufacturer can ensure that their device is properly registered and that they are compliant with TFDA regulations.
Here are some of the benefits of having a local authorized representative in Taiwan for medical device registration:
The LAR can help you navigate the registration process and ensure that your application is compliant with TFDA requirements.
The LAR can represent you in dealings with TFDA, which can save you time and effort.
The LAR can provide you with local market insights and help you build relationships with key stakeholders in Taiwan.
If you are planning to register a medical device in Taiwan, it is important to choose a reputable LAR who has experience in the medical device industry. Artixio, as your LAR, can provide you with a clear understanding of their services and the fees involved.
Are there any post-registration obligations or reporting requirements for medical devices as per TFDA regulations in Taiwan?
Yes, there are a number of post-registration obligations or reporting requirements for medical devices as per TFDA regulations in Taiwan. These obligations and requirements are designed to ensure that medical devices remain safe and effective throughout their life cycle.
Some of the key post-registration obligations and reporting requirements include:
Change notification: If you make any changes to your medical device, you must notify the TFDA within 30 days of the change. This includes changes to the device's design, manufacturing process, or labeling.
Adverse event reporting: You must report any adverse events (AEs) associated with your medical device to the TFDA within 15 days of becoming aware of the AE. An AE is any undesirable or unexpected event that occurs during the use of a medical device, and that could potentially harm the patient.
Field safety corrective action (FSCA): If you become aware of a safety issue with your medical device, you must take steps to correct the issue. This may involve issuing a recall of the device, or implementing other corrective actions.
Product evaluation: You must periodically evaluate your medical device to ensure that it remains safe and effective. This evaluation should include a review of the device's design, manufacturing process, and clinical data.
In addition to these obligations and requirements, you may also be required to comply with other regulations, such as the Good Manufacturing Practices (GMP) regulations.
Are there any exemptions or expedited processes available for certain types of medical devices as per TFDA regulations in Taiwan?
Yes, there are a number of exemptions or expedited processes available for certain types of medical devices as per TFDA regulations in Taiwan. These exemptions and expedited processes are designed to facilitate the registration of medical devices that are considered to be low-risk or that have already been approved by other regulatory authorities.
Some of the key exemptions and expedited processes include:
Exemption for Class A devices: Class A devices are considered to be low-risk devices, and they are exempt from the full registration process. These devices can be registered through a simplified registration process.
Expedited registration for devices approved by other regulatory authorities: If your device has been approved by another regulatory authority that is considered to be equivalent to the TFDA, you may be eligible for expedited registration. This means that your device can be registered in Taiwan without the need to submit a full registration dossier.
Special access routes (SARs): SARs are available for devices that are urgently needed in Taiwan, but that have not yet been approved by the TFDA. SARs allow these devices to be used on patients in Taiwan under certain conditions.
In addition to these exemptions and expedited processes, you may also be able to benefit from other regulatory schemes, such as the TFDA's Regulatory Approval Pathway (RAP) scheme. The RAP scheme is designed to facilitate the registration of innovative medical devices that have the potential to significantly improve patient care.
Are there any unique considerations or requirements for software or digital health applications in Taiwan as per TFDA regulations?
es, there are a number of unique considerations or requirements for software or digital health applications in Taiwan as per TFDA regulations. These considerations and requirements are designed to ensure that software or digital health applications are safe, effective, and secure.
Some of the key considerations and requirements include:
Risk classification: Software or digital health applications are classified into four risk classes: Class I, Class II, Class III, and Class IV. The risk class of the application will determine the evaluation route and the documentation requirements for registration.
Cybersecurity: Software or digital health applications must be designed and developed with cybersecurity in mind. This includes ensuring that the application is protected from unauthorized access, use, disclosure, disruption, modification, or destruction.
Data protection: Software or digital health applications must comply with the Personal Data Protection Act (PDPA) of Taiwan. This means that the application must be used in a way that protects the privacy of the data that it collects or processes.
Clinical evaluation: For Class III and Class IV applications, a clinical evaluation report (CER) must be submitted to TFDA. The CER must demonstrate that the application is safe and effective for its intended use.
Labeling and packaging: Software or digital health applications must be labeled and packaged in a way that is clear, accurate, and informative. The labeling must include information about the intended use of the application, the risks associated with the application, and the instructions for use.
Are there any local standards or additional testing requirements beyond international standards for medical devices in Taiwan per TFDA regulations?
Yes, there are a number of local standards or additional testing requirements beyond international standards for medical devices in Taiwan per TFDA regulations. These standards and requirements are designed to ensure that medical devices meet the specific needs of the Taiwanese market.
Some of the key local standards or additional testing requirements include:
Therapeutic Goods Administration (TGA) Standards: Taiwan has adopted a number of TGA standards for medical devices. These standards are developed by the Therapeutic Goods Administration (TGA) of Australia.
Singapore Standards (SS): Taiwan has also adopted a number of SS standards for medical devices. These standards are developed by the Singapore Standards Council (SSC).
Additional testing: In addition to the requirements of international standards, medical devices may also be required to undergo additional testing in Taiwan. This testing may be required to assess the performance of the device in a tropical climate or to assess the safety of the device for use by the Taiwanese population.
Can I use a foreign clinical study or data for medical devices registration purposes in Taiwan per TFDA regulations?
Yes, you can use a foreign clinical study or data for medical devices registration purposes in Taiwan per TFDA regulations. However, there are a number of factors that you need to consider before doing so.
Factors to consider:
The risk classification of the device: The risk classification of the device will determine the extent to which you can rely on foreign clinical data. For example, you may be able to rely on foreign clinical data for Class A devices, but you may need to conduct additional clinical trials for Class C or Class D devices.
The similarity of the population: The population that was studied in the foreign clinical trial should be similar to the population that will be using the device in Taiwan. If the populations are not similar, you may need to conduct additional clinical trials in Taiwan.
The availability of local data: If there is local clinical data available, you should generally use the local data. This is because the local data will be more relevant to the Taiwanese market.
How to use foreign clinical study or data:
If you decide to use foreign clinical study or data, you will need to submit a justification to TFDA. The justification should include information about the following:
The risk classification of the device
The similarity of the population
The availability of local data
The reasons why you believe that the foreign clinical data is relevant to Taiwan
TFDA will review your justification and make a decision on whether to allow you to use the foreign clinical data.
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