Online CourseOnline Course Medical Device Certificate ElectiveMedical Device Certificate Elective

Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview [4.0 RAC]

4.0 RAC Credits Member: $465.00 Nonmember: $640.00
Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview [4.0 RAC]
Navigating global regulatory markets in Asia can be a challenge, particularly when each country has unique regulations and requirements. Every country has its own body or system of legal requirements for placing medical devices in the market. Therefore, comprehending the various Asian laws and regulations is the key to registration of products.

This course examines and introduces medical device regulations and registration requirements in China, South Korea, Japan and Singapore. You will learn how to obtain and maintain product approvals, and receive the most up-to-date information about pre-market and post-market regulations.

Topics include product registration, labeling requirements, quality systems, manufacturing and distribution licenses, postmarket surveillance regulations, clearance strategies and time schedules. You will leave this course with a thorough summary of the Asian regulations so you can effectively plan and manage a submission, and actively manage potential registration or compliance issues.

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, South Korea, Japan and Singapore 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

Learning Objectives

Upon completion of this course, participants should be able to:
  • Discuss medical device regulations in China, South Korea, Japan and Singapore
  • Apply practical guidance on how to comply with the requirements
  • Describe how these requirements are interpreted and applied in these rapidly growing markets
  • Implement quality system/Good Manufacturing Practice (GMP) requirements that comply with the medical device regulations
  • Define product registration strategies and define labeling requirements for medical devices in the Asian markets
  • Identify documentation required for the application and approval of medical devices in China, South Korea, Japan and Singapore

Lesson Titles
  • Lesson 1: Chinese Regulatory Requirements
  • Lesson 2: South Korean Regulatory Requirements
  • Lesson 3: Japanese Regulatory Requirements
  • Lesson 4: Singaporean Regulatory Requirements

Enrollment Period: 12 months
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