,
Freyrの中国市場における医療機器分野の専門知識
- 中国NMPA規制および申請戦略の包括的対応
- 実質的同等性分析のための先行機器の特定
- 適用可能な規格の特定
- NMPA規制および国際規格に基づくギャップ分析
- 技術ファイルの全セクションを適切な形式で作成
- 技術文書の発行
- 審査における不備への対応と回答
- 機器承認のための仲介サービス
- 不備対応のためのコンサルティングサービス
- 事業所登録
- 機器リスト作成および登録データベースの管理
- 機器のライフサイクル管理
中国で医療機器のシームレスな承認プロセスを体験してください
私たちの専門家に会いましょう
サマー・シア - ア
ソシエイトディレクター
With over 20 years of experience, including 15 years in medical device regulatory affairs, Summer has excelled in navigating both pre-market and post-market requirements. Her expertise has been instrumental in guiding numerous foreign and local manufacturing companies entering the Chinese market. Summer’s leadership has been demonstrated through her roles heading multinational Quality Assurance and Regulatory Affairs teams. She holds an MBA and is a certified Lead Auditor by BSI, enabling her to proficiently manage complex compliance landscapes.
レイラ・タン - ス
ペシャリスト
With over 8 years of experience, including 5 years in the medical device industry, focusing on 2 years in medical device regulatory affairs. Layla has excelled in file submission and preservation both pre-market and post-market. She keep eyes on any change/update from NMPA and provides support for numerous foreign and local manufacturing companies entering the Chinese market.
アラン・ジャン -
マネージャー
With 10 years experience of medical device registration. Allan has rich experience in active and non-active medical device, guiding numerous foreign and local manufacturing companies and helping them to get more than 100 certificates approved by NMPA. He had participated in drafting CMDE guideline and industry standards. He can guide manufacture with fast and compliant registration strategy.
中国におけるNMPA承認のための規制専門知識
NMPA承認プロセスを加速
NMPA提出を迅速化するための実績のある戦略
カスタマイズされたサービス
リスク軽減
中国で医療機器を登録する準備はできていますか？ 今日中にお問い合わせいただければ、医療機器が中国の医療機器規制に準拠し、迅速な承認を得られるようお手伝いします。
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
