This intensive, two-day workshop will provide an overview of electronic submissions to the China NMPA for devices and IVDs called electronic Regulated Product Submissions (eRPS), which are similar to eCTD submissions to the U.S. FDA. eRPS went into effect on June 24, 2019 in China and affects domestic class III, imported class III and imported class II medical devices and IVDs. The workshop will review the eRPS structure as well as the key elements and necessary processes for building complete and successful electronic submissions. By attending this program, regulatory professionals and overseas manufacturers will gain a thorough understanding of eRPS and better position themselves to meet the new requirements in China.

Objectives

After this program, participants will…

• Understand the key regulations and process of China NMPA registration.
• Know the key components of the eRPS structure and be familiar with the online eRPS portal.
• Know best practices regarding eRPS dossier content.
• Have a thorough understanding of how to apply for and obtain a China Certificate Authority (CA) certificate.

Agenda

• Introduction to and overview of the China NMPA registration process
• An interactive exercise to aid in understanding the key steps for registration in China
• General introduction to China electrical Regulated Product Submission (eRPS)
• What is a CA certificate? How does one apply for a CA certificate?
• The new step for Chinese submissions: filing review requirements and standards for medical devices and IVDs
• Comprehensive review of eRPS submissions, including:
  • The RPS-ToC catalog and requirements
  • An introduction to the RPS catalog structure
  • A review the entire lifecycle of an electrical submission, from first steps to eRPS
  • Best practices, tips and case studies