This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

Ren Dazhi
ARQon China and Former Director of Beijing Institute of Medical Device Test & Beijing Center for Medical Device Quality Supervision and Testing at National Medical Products Administration (NMPA), China

Profile

  • Member of the First Executive Committee of the Medical Device Classification Committee, China Food and Drug Administration.
  • Member of the First Council of the Medical Device Professional Committee, China Drug Administration Research Association.
  • Member of the Technical Committee of National Medical Clinical Laboratory and Standardization of In-Vitro Diagnostics
  • Since 2001, Dazhi has been engaged in the supervision and management of medical device classification and standard management, testing, GMP quality system, review, approval. He is responsible for pre-market review and approval of medical devices, post-marketing supervision. He also participated in the revision and discussion of “China's Medical Device Supervision and Administration Regulations", "Medical Device Registration Management Measures" and other important regulatory documents. He organized the formulation of Beijing medical device registration and regulatory documents; participate in the organization and revision of a number of medical device registration technical guidelines and standards; provided regulatory advice and professional guidance to several medical device enterprises for their product registrations.

Agenda Sessions

  • CHINA COMPETENT AUTHORITY PERSPECTIVE: Keeping Pace with Chinese Regulations - Practical Advice for MedTech Manufacturers

    10:35
  • ROUNDTABLE: North Asia Regulations

    12:05