The Ministry of Health and Welfare (MOHW)
Medical Device Registration in Taiwan
Qserve’s experts guide manufacturers through the medical device registration process in Taiwan, including the registration of in vitro diagnostics (IVDs), with the Taiwan Food and Drug Administration (TFDA).
Taiwan has a well-established regulatory framework overseen by the Ministry of Health and Welfare (MOHW). The TFDA manages the regulatory system for medical devices, ensuring safety, quality, and compliance through product registration, clinical trial approvals, and post-market surveillance.
With Taiwan’s new Medical Devices Act (May 2021) introducing changes in classification, registration fees, and stricter post-market surveillance, manufacturers must navigate evolving regulations effectively.
Qserve supports you in streamlining the registration process, ensuring compliance with TFDA requirements, and enabling smooth market entry into Taiwan.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with medical device registration in Taiwan or a go-to-market strategy?
Contact us
How Qserve Supports Medical Device Registration in Taiwan
Regulatory Compliance in Taiwan
Qserve’s regulatory specialists have extensive experience with Taiwan’s medical device market. We help manufacturers navigate different registration routes, ensuring compliance and optimizing time to market.
If your company already has a regulatory strategy, we provide hands-on support to bring it to life. Our team assesses your technical documentation, identifies gaps, and ensures your product is Taiwan-ready.
We also assist in the submission process and provide regulatory guidance for Quality System Documentation (QSD), which is mandatory for Class I (sterile), Class II, and Class III devices.
With our deep understanding of APAC medical device regulations, Qserve helps simplify the registration process and ensures compliance with Taiwan’s evolving regulatory landscape.
Medical devices and IVDs
Registration Routes in Taiwan
Medical Devices
- Pre-market approval is required for all medical devices before they can be sold in Taiwan.
- The TFDA issues a medical device permit license upon successful product registration.
- If no similar device has been approved in Taiwan, your device will be classified as a PMA (Pre-market Approval) device, regardless of its approval status in other markets.
- Class II and III devices must have approval from their home country before registration in Taiwan.
- GMP compliance is mandatory for Class I (sterile), Class II, and Class III devices before the TFDA grants product licenses.
IVD Registration
- Class I and II IVDs: Do not require formal registration.
- Class III and New IVDs: Must undergo a two-stage review process (Administrative and Technical Review).
The Role of a Taiwan Agent in Medical Device Registration
Tawain Responsible Person
Local Representative Requirement
Manufacturers without a local office must appoint an in-country regulatory representative, a Taiwan Agent, to ensure compliance with TFDA regulations.
Your Taiwan Agent must:
- Be a legally established entity in Taiwan.
- Hold a Pharmaceutical Sales License to perform regulatory activities.
Taiwan Agent Responsibilities
- Registration Submission: Preparing and submitting all necessary documentation to the TFDA.
- QSD Approval: Assisting with Quality System Documentation (QSD) approval, mandatory for Class II, Class III, and specific Class I devices.
- Regulatory Liaison: Acting as the primary connection between your company and the TFDA.
- SAE Reporting: Managing Serious Adverse Event (SAE) reporting.
- License Maintenance: Ensuring compliance with QSD license renewals.
- Medical Device Product License Management: Holding your TFDA-approved Medical Device Product License.
The Taiwan Agent’s details must appear on the device's Chinese label, along with the TFDA registration number. Distributors typically add their information via stickers to comply with local requirements.
Need a trusted Taiwan Agent for your medical device registration?
Contact us to learn how Qserve can assist you.