New service for medical device manufacturers
Before placing a medical device on the Taiwan market, confirm the applicable pathway of the Taiwan Food and Drug Administration (TFDA). Captain International now provides two integrated services for Taiwan-based medical device manufacturers: QMS implementation and medical device license applications. We support work from quality system setup through license applications or registration.
01 Why QMS and a license may be needed
Under the Medical Devices Act, devices generally require review and registration and a license; products designated for the registration pathway follow that process instead. Manufacturers must also determine applicable QMS and manufacturing permit requirements based on the product and manufacturing activities. Published exemptions apply only under their stated conditions.
- Establish the QMS under the Medical Device Quality Management System Regulations, aligned with the ISO 13485 framework. An ISO 13485 certificate does not replace a TFDA manufacturing permit.
- Complete the applicable manufacturing permit, product license or registration process before manufacturing and marketing as required by law.
- QMS and product submissions are connected. Gaps in documentation or inspection readiness can delay market entry.
02 Service 1: QMS implementation
We help establish and maintain a QMS aligned with Taiwan's Medical Device Quality Management System Regulations and applicable ISO 13485 requirements, and prepare for TFDA inspections and manufacturing permit applications.
- Develop QMS documents and organize document controls.
- Implement key processes such as risk management (ISO 14971), design and development controls, and supplier management.
- Conduct a mock audit before inspection and support corrective actions.
- Provide on-site support during the inspection.
03 Service 2: Medical device license applications
We help determine whether review and registration or registration applies based on device risk class (Class I, II or III), product category and published requirements. Where a license is required, its validity is up to five years, subject to the issued license.
- Assess product classification and recommend an application strategy.
- Prepare technical documentation, coordinate testing and organize specification information.
- Support submission, review communications and responses to requests for additional information.
- Advise on license renewal and changes, and on annual reporting for registered products.
04 Why work with us
- Consulting and application support in one coordinated engagement.
- Familiarity with TFDA requirements and practical processes to reduce avoidable rework.
- Clear progress tracking so your team can stay focused on operations.
05 Who this is for
This service is mainly for Taiwan-based medical device manufacturers, whether applying for the first time or strengthening an existing system and preparing renewals.
Frequently asked questions
How does QMS relate to ISO 13485?
Taiwan's QMS is implemented under the Medical Device Quality Management System Regulations and aligns with the ISO 13485 framework. Companies must still meet Taiwan's regulations and applicable manufacturing permit requirements; an ISO 13485 certificate alone is not a substitute. We can help plan implementation based on your current system.
Do Class I products also need a QMS?
This depends on product category, sterilization status and published exemption conditions. Class I status alone does not establish that inspection or a manufacturing permit is unnecessary. Exemptions and whether the product follows review or registration must be checked separately.
How long does it take to obtain a license?
Timing varies with device classification, document completeness and review. We provide a more specific estimate and schedule after assessing the case.
How long is a license valid?
Medical device licenses are valid for up to five years, subject to the issued license. An extension may be requested before expiry, with each extension limited to five years. Registered products follow separate maintenance requirements, including annual reporting where applicable.
Official references and consultation
- TFDA medical device regulations
- TFDA Class I medical device application guidance
- TFDA registration and annual reporting FAQ
Share the product's intended use, classification information, manufacturing site and planned market date so we can assess the applicable process.
Book a consultation on medical device QMS and license applications