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公司介紹

富甲顧問有限公司專注於醫療器材法規與醫療器材品質系統顧問服務，協助國內外醫療器材廠商順利進入台灣、美國及國際市場。

我們提供 TFDA、FDA、ISO 13485、SaMD 與 AI 醫療器材等專業法規服務，並涵蓋協助客戶申請產品分類判定、查驗登記、QMS 建置、技術文件撰寫及國際法規策略規劃。

我們憑藉豐富的實務經驗與中英文技術文件能力，富甲顧問致力於協助客戶提升法規效率、降低上市風險，加速醫療器材產品成功上市。

Company Profile

Fuchia Consulting 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.

醫材器材法規顧問服務

Medical Device Regulatory Consultant Service

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。

我們的服務涵蓋：

TFDA 醫療器材查驗登記與 QSD 申請
FDA 510(k)、eSTAR、Device Listing 與 U.S. Agent 支援
ISO 13485 品質系統與 GMP 法規輔導
IEC 62304、IEC 62366、ISO 14971 技術文件建置
AI／ML 智慧醫療器材法規策略
醫療器材技術文件、STED、CER 與軟體驗證文件撰寫
法規差異分析、稽核準備與上市策略規劃

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。

Fu Jia Consulting 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:

TFDA medical device registration and QSD application support
FDA 510(k), eSTAR, Device Listing, and U.S. Agent assistance
ISO 13485 and GMP quality system consulting
IEC 62304, IEC 62366, and ISO 14971 documentation support
Regulatory strategy for AI/ML-based medical devices
STED, CER, software validation, and technical file preparation
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.

醫療器材_進出口及許可證代理服務

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。

我們的服務包含：

醫療器材進出口流程諮詢
醫療器材許可證代理申請
TFDA 醫療器材查驗登記與 QSD 申請協助
FDA Device Listing 與 U.S. Agent 支援
商品分類與法規適用性評估
進口文件與技術文件審查
海關、衛福部及相關主管機關申請協調
上市前法規策略與市場導入規劃

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。

Fu Jia Consulting 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.