購物車
0
$0.00

                  專業醫材認證諮詢                        Professional Consulting for Medical Device Certification

                  專業資深顧問團隊為您服務                       A team of senior professional consultants at your service

       公司介紹 / Company Profile

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。

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。 

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).

我們的服務涵蓋 / Our Services Include：

  • TFDA 查驗登記與 QSD 申請 

  • TFDA medical device registration and QSD application support

  • FDA 國際市場與 U.S. Agent 支援 

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

  • ISO 13485 品質系統與 GMP 法規輔導 

  • ISO 13485 and GMP quality system consulting

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

  • IEC 62304, IEC 62366, and ISO 14971 documentation support

  • AI／ML 智慧醫療器材法規策略 

  • Regulatory strategy for AI/ML-based medical devices

  • 技術文件撰寫 (STED / CER / 軟體驗證) 

  • STED, CER, software validation, and technical file preparation

  • 差異分析、稽核準備與上市規劃 

  • 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.

       醫療器材_進出口及許可證代理服務             Medical Devices – Import / Export and License Agency Services

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。

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. 

我們的服務包含 / Our services include:

  • 醫療器材進出口流程諮詢
  • Medical device import and export consultation
  • 醫療器材許可證代理申請
  • License holder and regulatory agent services
  • TFDA 醫療器材查驗登記與 QSD 申請協助
  • TFDA medical device registration and QSD application support
  • FDA Device Listing 與 U.S. Agent 支援
  • FDA Device Listing and U.S. Agent assistance
  • 商品分類與法規適用性評估
  • Product classification and regulatory applicability assessment
  • 進口文件與技術文件審查
  • Import documentation and technical file review
  • 海關、衛福部及相關主管機關申請協調
  • Coordination with customs and regulatory authorities
  • 上市前法規策略與市場導入規劃
  • 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.