Overview of Medical Device Regulatory System in China

Short Course / 1 day

Course Information
Learning Outcomes
Course Schedule
Lesson Plan
Certification
Entry Requirements
Course Fees

Course Information

Singapore is one of the top manufacturers of medical device and IVD in the world. Many companies are developing market plan to export their products to China. This course will provide an overview of medical device industry and regulatory system in China.

This course is suitable for companies or venture capitalists who have a keen interested in expanding their business in the biomedical device sector in China. This course will prepare them with the regulatory knowledge required to strategically market their medical device products.

Learning Outcomes

Course participants will gain a deeper insights into the medical device legislation in China, and tips to expedite their product registration in China to gain a head start in business development.

  • The medical device legislation in China
  • The authority for medical device registration
  • The process of registration
  • How to expedite your registration in China
  • How to use your current data in other regions to support your registration in China

Course 
Schedule

Course Date: 1 April 2021
Application Period: 1 March to 20 March 2021
Duration: 1 day
Time: 9am to 6pm
Ngee Ann Polytechnic reserves the right to reschedule/cancel any programme, modify the fees and amend information without prior notice.

Lesson Plan

This course consists of 1 modules:

  • General introduction on MD market in China (1 hour)
  • The MD legislation in China and main legislation updates (0.5 hour)
  • The authority for MD registration and the structure of the department in NMPA for MD registration (0.5 hour)
  • The process of registration the process and the key notes (1 hour)
  • How to expedite your registration in China (1 hour)
  • How to make use of use your current data in other regions to support your registration in China (1 hour)
  • Case study (2 hours)

Certification

A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).


Entry Requirements

Applicants with any of the following qualifications are invited to apply for the course:

This course will be relevant to all persons working in medical device industry, including persons involved in regulatory, documentation, process development and quality assurance.

Course Fees

Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review.
The course is eligible for SkillsFuture Credit. For more information on the SkillsFuture Credit click here.
For enhanced training support, enter SME in the promo code during course application.

Union Training Assistance Programme (UTAP)
NTUC members enjoy 50% unfunded course fee support for up to $250 each year (or up to $500 for NTUC members aged 40 years old and above) when you sign up for courses supported under UTAP (Union Training Assistance Programme). Please visit e2i’s website to find out more.

Ngee Ann Polytechnic reserves the right to reschedule / cancel any programme, modify the fees and amend information without prior notice.

Applicants / Eligibility Fees
Full Course Fee$288.90
Singaporeans and Permanent Residents$86.67
Singaporeans qualified for SkillsFuture Mid-Career Enhanced Subsidy$32.67
Singaporeans and Permanent Residents qualified for Enhanced Training Support for SMEs$32.67