Medical Devices: China Regulations
Navigating China’s regulatory market can be challenging, particularly when authorities impose unique regulations and requirements. However, understanding China’s laws and regulations is critical for managing the country’s regulatory compliance and product approvals.
This course introduces the fundamentals of China’s medical device regulations and registration requirements formulated and implemented by the China National Product Administration (NMPA). Course topics cover all key aspects of a product’s life cycle, including: quality systems manufacturing; product registration; labeling requirements; distribution management; postmarket surveillance regulations; clearance strategies; and estimated costs and time schedules whenever possible. The course also provides an overview of China’s regulations to enable students to effectively plan and manage a submission and actively manage potential registration and compliance issues.
Special attention will be given to product registration process and requirements by providing an overview of China’s medical device regulations and the process from the basic requirements for medical device safety and performance, the medical device classification system, technical documentation requirements to submission, and NMPA review. Techniques for communicating with NMPA reviewers, testing centers, and other government offices will also be offered.
At a Glance
- Target Audience: This course is intended for the functional groups and personnel in a medical device organization that support approvals and registrations in China including business and product development, registration, quality assurance, regulatory affairs, clinical affairs, marketing, manufacturing, R&D and technical engineering.
- Learning Level: Basic
- Total Length of Course: 4 Hours
- RAC Points: 4
- Medical Device Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:- Explain the regulatory framework for China’s medical device regulations
- Gain practical guidance on how to comply with the regulatory requirements
- Navigate through product registration (and registration extension) and labeling requirements for devices entering the China market
- Implement strategies to overcome regulatory hurdles, including but not limited to postmarket alert (vigilance) system and clinical trial applications
- Understand which reports and records are required to meet China’s medical device requirements
- Be familiar with the resources necessary for investigation of regulations or other information
Lesson Titles
- Lesson 1: Chinese Regulatory Agencies
- Lesson 2: Overview of Key Regulations
- Lesson 3: Classification and Its Implications
- Lesson 4: Registration of Medical Devices
- Lesson 5: Labeling, IFU Requirements, and Certificate Changes
- Lesson 6: Non-Traditional Pathways for Device Approval
- Lesson 7: Manufacturing in China and Quality Management Systems
- Lesson 8: Postmarket Surveillance
This course is also included in:
