Taiwan FDA Medical Device Registration Services
Unlock Taiwan’s medical device market with expert regulatory guidance, quality system oversight, and an independent Taiwan agent.
With a presence in Taipei and a deep understanding of Taiwan’s Medical Devices Act, Cisema helps international manufacturers of medical devices and in vitro diagnostics (IVDs) achieve TFDA (Taiwan Food and Drug Administration) approval efficiently and reliably. Our team manage every aspect of your registration — from documentation and Quality System Documentation (QSD) preparation to long-term compliance across the product lifecycle.
Services Overview
As your Taiwan Registration Holder (TRH), Cisema takes ownership of your medical device registration process in Taiwan — guiding you from initial classification strategy through post-market surveillance. Acting as your in-country regulatory representative, we deliver end-to-end support for:
- Device classification and regulatory strategy for TFDA approval
- Technical reviews and Quality System Documentation (QSD)
- Medical device registration submissions for Class I, II, and III devices
- Medical device permit license amendments and renewals
- Post-market obligation management
- Documentation aligned with Good Manufacturing Practice (GMP) requirements and ISO 13485, ensuring conformity with Taiwan’s medical device expectations
From risk assessment and QMS alignment to TFDA application support and labeling compliance, Cisema simplifies your path to market — giving you clarity, speed, and control.
Taiwan IVD & Medical Device Registration Services
Cisema’s team manages your full device registration in Taiwan, aligning with the Taiwan Food and Drug Administration authority’s requirements and supporting a seamless market entry.
Regulatory Strategy and Classification
- Classify your Taiwan medical device or IVD under Taiwan’s risk-based framework (Class I, Class II, or Class III)
- Determine whether fast-track or pre-market approval based on reference countries is applicable
- Define the most effective regulatory pathway according to your primary intended actions
Quality System Documentation (QSD) Registration
Before submitting your product registration application to TFDA, most manufacturers must obtain a Quality System Documentation (QSD) certificate. This mandatory step verifies your compliance with ISO 13485 or an equivalent quality management system. Cisema guides you in preparing and submitting your full QSD application and managing all interactions with TFDA until your certificate is issued.
QSD requirements include:
- Mandatory for all Class II and Class III devices, and many Class I products
- Exemptions may apply to certain Class I non-sterile, non-measuring devices
- QSD approval is performed as a remote, paper-based review by the TFDA
- Documentation includes ISO 13485 certificate, SOPs, quality manual and facility details
Both the QSD and product registration can be submitted in parallel; however the TFDA will only issue the medical device permit license once QSD approval is complete. The standard QSD review time is around 6 months, and the certificate is valid for 3 years.
Registration Application and TFDA Submission
- Submit through the TFDA e-Portal and manage all administrative and technical reviews
- Act as your regulatory contact for communication with the TFDA
- Localize Instructions for Use (IFU), packaging, and labeling to meet Taiwan Food and Drug Administration standards
- Coordinate submission fees and respond to authority feedback throughout the pre market approval process.
Post-Approval Services
- Handle renewals, reclassification, and amendments to the medical device permit license
- Manage adverse event reporting, serious adverse event follow-up, and Field Safety Corrective Actions (FSCA) coordination.
Taiwan Agent and Taiwan Registration Holder Services
Foreign manufacturers must appoint a Taiwan agent or in country regulatory representative as the legal license holder to register with the Taiwan Food and Drug
Administration. Cisema acts as your compliant TRH, fulfilling all regulatory duties transparently.
What we do:
- Serve as your legal license holder for all Taiwan medical device, IVD and combined product registrations
- Submit and maintain your product license with TFDA
- Issue Letters of Authorization to your preferred importers and distributors
- Enable flexibility in changing distributors without re-registration
- Monitor post-market updates and ensure ensuring compliance with the Medical Devices Act
- Manage direct prevention actions like FSCA and recalls
- Maintain your quality system, and support audits and inspections tied to ISO 13485.
Quality Control Inspection Services in Taiwan
Cisema also provides tailored inspection services for Taiwan medical devices and IVDs to ensure compliance with local and international standards.
Our services include:
- Verify packaging, labeling, and shipping conditions upon arrival
- Review documentation including invoices, certifications, and declarations of conformity
- Confirm product readiness for the Taiwan’s market
- Inspect during repackaging or relabeling for hygiene, SOPs, and quality system control
- Validate traceability and batch consistency
- Conduct AQL sampling and performance checks
- Ensure conformity of labeling and IFU with Taiwan’s regulatory requirements
- Support Good Manufacturing Practice audits and TFDA site inspections
- Collaborate with third-party bodies for tailored compliance audits
- Conduct serial number validation and corrective action reviews.
Why Partner with Cisema?
- Proven experience across Asia Pacific, including the Taiwan medical device sector
- Legally neutral TRH model to support distributor flexibility
- Fully integrated service offering: registration, representation, and inspection
- Trusted by startups and global manufacturers alike
- Direct communication with TFDA reviewers and compliance officials.
Request a Proposal
Ready to begin your Taiwan medical device registration? Cisema is your expert partner for TFDA licensing, quality inspections, and long-term regulatory compliance.
Other Markets We Support for Medical Device & IVD Registration:
In addition to Taiwan, Cisema supports IVD and device registration, regulatory representation, and quality inspection services in:
We also advise clients in pharmaceuticals, biopharma, health foods, cosmetics, and industrial goods. Whether your product is entering one market or multiple, we tailor your compliance strategy for success.
