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Compétences de Freyr pour le marché des dispositifs médicaux en Chine:
- Stratégie réglementaire et de soumission NMPA complète pour la Chine
- Identification d'un dispositif de référence pour l'analyse d'équivalence substantielle
- Identification des normes applicables
- Analyse des écarts selon la réglementation NMPA et les normes internationales
- Compilation de toutes les sections du dossier technique dans le format approprié
- Publication de la documentation technique
- Traitement des déficiences relevées lors de l'examen et réponses
- Services de consultation pour le traitement des déficiences
- Enregistrement de l'établissement
- Liste des dispositifs et maintenance de la base de données d'enregistrement
- Gestion du cycle de vie des dispositifs
Faites l'expérience d'un processus d'approbation sans accroc pour les dispositifs médicaux en Chine.
Cliquez pour prendre rendez-vous avec nos experts dès aujourd'hui !
Rencontrez nos experts
Summer Xia
Directrice Associée
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.
Layla Tan
Spécialiste
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.
Allan Zhang-
Responsable
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.
Pourquoi choisir Freyr ?
Expertise réglementaire pour l’approbation de la NMPA en Chine
Accélérez votre processus d'approbation par la NMPA
Stratégies éprouvées pour accélérer les soumissions à la NMPA
Services sur mesure
Atténuation des risques
Êtes-vous prêt à enregistrer votre dispositif médical en Chine ? Contactez-nous dès aujourd'hui pour garantir que votre dispositif médical est conforme avec toutes les réglementations chinoises sur les dispositifs médicaux et pour obtenir une approbation rapide.
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.
