FuChia Consultant Co., Ltd. specializes in medical device regulatory and quality system consulting services, supporting global manufacturers in accessing Taiwan, U.S., and international markets.

Our expertise covers TFDA, FDA, ISO 13485, SaMD, and AI/ML medical device regulations, including product classification, regulatory submissions, QMS implementation, technical documentation, and global regulatory strategies.

With extensive hands-on regulatory experience and strong bilingual technical documentation capabilities, we help clients improve regulatory efficiency, reduce compliance risks, and accelerate successful market entry for medical devices.

FuChia Consultant Co., Ltd. provides professional and efficient regulatory consulting services for medical device companies seeking access to Taiwan, U.S., and global markets. We specialize in medical device registration, quality system compliance, FDA and TFDA regulatory submissions, and technical documentation support for digital health and Software as a Medical Device (SaMD). 

Our Services Include：

A. TFDA medical device registration and QSD application support

B. FDA 510(k), eSTAR, Device Listing, and U.S. Agent assistance 

C. ISO 13485 and GMP quality system consulting 

D.IEC 62304, IEC 62366, and ISO 14971 documentation support 

E. Regulatory strategy for AI/ML-based medical devices

F. STED, CER, software validation, and technical file preparation 

G. Gap analysis, audit readiness, and market entry planning 

We are committed to helping manufacturers achieve regulatory compliance efficiently, reduce submission risks, and accelerate time-to-market through practical and internationally aligned regulatory solutions. 

FuChia Consultant Co., Ltd. provides professional import/export consulting and license agent services for medical devices, medical software, and related healthcare products. We assist domestic and international manufacturers in regulatory applications, import procedures, and market entry compliance in Taiwan and global markets.  

Our services include:

A. Medical device import and export consultation 

B. License holder and regulatory agent services 

C. TFDA medical device registration and QSD application support 

D. FDA Device Listing and U.S. Agent assistance 

E.Product classification and regulatory applicability assessment 

F. Import documentation and technical file review 

G. Coordination with customs and regulatory authorities 

H.Pre-market regulatory strategy and commercialization planning

We help clients reduce regulatory and customs risks, improve submission efficiency, and establish compliant product management processes to support successful market access and international business operations.  

FuChia consulting team has deep roots in the biomedical engineering field, having held key regulatory and quality assurance leadership roles in several renowned biomedical and medical device enterprises. Backed by extensive hands-on experience in cross-border marketing and supply chain management, we provide a global perspective to help enterprises navigate challenges and deliver precise, efficient regulatory and quality system solutions.

In regulatory and quality management, the team is not only proficient in the establishment of ISO 13485, QMS, and FDA QSR quality systems, but also covers Taiwan QSD factory registration, U.S. 510(k) clearance, and ISO 14064 sustainability and carbon reduction consulting. Furthermore, our consultants hold ISO 13485 and ISO 14064 Lead Auditor certifications issued by SGS, providing the strongest backing for your products to enter international markets.

In addition, the team has long been active across government, industry, and academic sectors. Our members currently serve as medical device regulation lecturers for the Taiwan Food and Drug Administration (TFDA), regulatory consultants for the Kaohsiung Medical Devices Commercial Association, and guest lecturers at Chung Yuan Christian University (CYCU) and National Taiwan University of Science and Technology (Taiwan Tech). Committed to advancing industry regulatory education and combining it with profound practical experience, FuChia Consultant continues to guide biomedical enterprises toward forward-looking horizons, delivering comprehensive and globally competitive professional services.