Taiwan Medical Device Registration
Unlock the Taiwanese market with expert regulatory guidance, quality system oversight, and an independent Taiwan agent, with Cisema.
We help foreign manufacturers of Taiwan medical devices and IVDs in Taiwan successfully register their products with the Taiwan Food and Drug Administration (TFDA), meet all documentation and quality system documentation requirements, and maintain compliance across the device lifecycle. As your Taiwan Registration Holder (TRH), we manage your Taiwan medical device registration process from initial classification strategy through post-market surveillance.
With a presence in Taipei and a deep understanding of Taiwan’s Medical Devices Act, Cisema acts as your trusted in country regulatory representative. We provide complete support for device classification, technical reviews, quality system documentation QSD, and registration submission for Class I, Class II, and III devices.
Whether registering a new product, seeking amendments to your medical device permit license, or managing post-market obligations, Cisema gives you clarity, speed, and control.
From risk assessment and QMS alignment to TFDA application support and labeling compliance, we simplify your path to market. We also assist with documentation aligned to the Good Manufacturing Practice requirements and ISO 13485, ensuring conformity with Taiwan medical device expectations.
IVD & Medical Device Registration in Taiwan Services
Cisema’s team manages your full medical device registration in Taiwan, aligning with the Taiwan Food and Drug Administration authority’s requirements and supporting a seamless market entry.
Regulatory Strategy & Classification
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. We guide you in preparing and submitting your full QSD application and managing all interactions with TFDA until your certificate is issued.
Registration Application & TFDA Submission
Post-Approval Services
Taiwan Agent & 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:
Medical Device Post-Market Surveillance & Vigilance Services
Cisema supports Taiwan Registration Holders with medical device post-market surveillance, safety reporting, corrective actions, and ongoing regulatory compliance.
Safety Surveillance & Reporting
Corrective Action & Recall Support
Distribution & Vigilance Records
Licence Renewal & Annual Declarations
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.
Incoming Goods Inspections
In-Process Quality Monitoring
Final Product Release Inspections
Special Inspection Projects
Why Work with Cisema?
Local expertise with global reach
Our bilingual teams bridge international quality standards with local regulations
Proven track record
Over 20 years supporting market approvals and compliance in China and Asia Pacific
End-to-end solutions
From system setup to post-market surveillance, we ensure quality management and regulatory compliance throughout the product lifecycle
Industry breadth
Cross-sector expertise in life sciences, food, veterinary, consumer and industrial goods
Cisema's Taiwan Office
Cisema (Taipei) Limited / 凱思瑪台北有限公司
7th Floor, No. 2-1 Wenhu Street
Neihu District, Taipei City 11445
Taiwan
