致力於提供專業且高效率的醫療器材法規顧問服務，協助國內外醫療器材廠商順利進入台灣、美國及國際市場。我們專精於醫療器材查驗登記、品質系統建置、FDA 與 TFDA 法規申請，以及智慧醫療與軟體醫療器材（SaMD）相關技術文件規劃。 

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).

我們的服務涵蓋 / Our Services Include：

A. TFDA 查驗登記與 QSD 申請 

A. TFDA medical device registration and QSD application support

B. FDA 國際市場與 U.S. Agent 支援

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

C. ISO 13485 品質系統與 GMP 法規輔導 

C. ISO 13485 and GMP quality system consulting

D. 國際法規技術文件建置 (IEC 62304 / 62366 / ISO 14971)

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

E. AI／ML 智慧醫療器材法規策略 

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

F. 技術文件撰寫 (STED / CER / 軟體驗證) 

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

G. 差異分析、稽核準備與上市規劃 

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

我們重視法規合規性與實務執行效率，協助客戶降低法規風險、縮短上市時程，並建立符合國際要求之醫療器材品質與技術文件系統。

 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.

提供專業的醫療器材、醫療軟體及相關產品之進出口與許可證代理服務，協助國內外廠商順利完成產品輸入、法規申請與市場流通作業。我們熟悉台灣 TFDA、FDA 及國際醫療器材法規要求，可依產品特性提供完整的法規評估與申請規劃。

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. 

我們的服務包含 / Our services include:

A. 醫療器材進出口流程諮詢

A. Medical device import and export consultation

B. 醫療器材許可證代理申請

B. License holder and regulatory agent services

C. TFDA 醫療器材查驗登記與 QSD 申請協助

C. TFDA medical device registration and QSD application support

D. FDA Device Listing 與 U.S. Agent 支援

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

E. 商品分類與法規適用性評估

E. Product classification and regulatory applicability assessment

F. 進口文件與技術文件審查

F. Import documentation and technical file review

G. 海關、衛福部及相關主管機關申請協調

G. Coordination with customs and regulatory authorities

H. 上市前法規策略與市場導入規劃

H. Pre-market regulatory strategy and commercialization planning

我們協助客戶降低法規與通關風險，提升申請效率，並建立符合台灣及國際法規要求之產品管理流程，讓產品能更快速、安全地進入市場。

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. 

富甲顧問團隊深耕生醫工程領域，曾任職多間知名生醫與醫材企業之法規與品保要職，並具備豐富的跨國市場行銷與供應鏈管理實戰經驗，能為企業把關全局，提供精準、高效的醫療器材法規與品質系統解決方案。

在法規與品質管理上，顧問團隊不僅精通ISO 13485、QMS、FDA QSR品質系統建置，更涵蓋QSD廠登、美國510(k)上市許可，以及ISO 14064永續減碳輔導，並已取得SGS頒發之ISO 13485與ISO 14064主導稽核員專業資格，為您的產品進軍國際市場提供最堅實的後盾。

此外，顧問團隊亦長期活躍於產官學界，現任食藥署醫療器材法規講師、高雄市醫療器材商業同業公會法規顧問，並受聘於中原大學與台灣科技大學擔任客座講師。富甲團隊不僅致力於推動產業法規教育，更結合深厚的實務經驗，持續為生醫企業引領前瞻方向，提供全方位且具國際競爭力的專業服務。

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.