,
Freyr의 중국 시장 의료기기 역량
- 중국 NMPA 규제 및 제출 전략 종합
- 실질적 동등성 분석을 위한 기존 기기의 식별
- 적용 가능한 표준의 식별
- NMPA 규정 및 국제 표준에 따른 갭 분석
- 적절한 형식으로 기술 파일의 모든 섹션 작성
- 기술 문서 발행
- 검토 결함 해결 및 응답
- 장치 승인을 위한 대행 서비스
- 결함 해결을 위한 상담 서비스
- 설립 등록
- 장치 목록 작성 및 등록 데이터베이스 유지
- 장치 수명 주기 관리
중국에서 의료기기의 원활한 승인 과정을 경험하세요
Lerne unsere Experten kennen!
서머 샤
부이사
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.
레일라 탄
전문가
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.
앨런 장 -
매니저
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.
왜 Freyr인가
중국 NMPA 승인을 위한 규제 전문성
NMPA 승인 프로세스를 가속화하세요
NMPA 제출을 신속하게 하는 검증된 전략
맞춤형 서비스
위험 완화
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.
