Overview of Medical Device Regulatory System in China

Offered by School of Life Sciences & Chemical Technology

Short Course / 1 day / TGS-2020509087

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: 23 Oct 2021
Application Period: TBC
Duration: 1 day
Time: 9am to 6pm
Delivery Mode: Classroom
Venue: Ngee Ann Polytechnic

This course may be conducted online subject to Covid-19 guidelines.

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

Lesson Plan

  • 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

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

Funding period for this course is from 23 Jan 2020 to 30 Sep 2024.

SkillsFuture Credit
All Singaporeans aged 25 and above can use their $500 SkillsFuture Credit from the government to pay for a wide range of approved skills-related courses. Visit the SkillsFuture Credit website (www.skillsfuture.sg/credit) to choose from the courses available on the Training Exchange course directory.

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.

Enhanced training support for SMEs
For enhanced training support for SMEs, enter SME in the promo code during course application.

Long Term Visit Pass Plus (LTVP+) holders, please furnish the following documents to the course administrator to qualify for SSG funding:
Self-sponsored learner (**LTVP+): Copy of your green visit pass card, with the word ‘PLUS’ on the back of the card.
Co-sponsored learner (##LTVP+): Copy of valid and current Letter of Consent (LOC) from MOM

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

(Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review.)

Applicants / Eligibility Fees
Full course fees$288.90
Singaporeans aged below 40, Permanent Residents & **LTVP+ qualified for SkillsFuture Funding$86.67
Singaporeans aged 40 & above qualified for SkillsFuture Mid-Career Enhanced Subsidy$32.67
Singaporeans, Permanent Residents & ##LTVP+ qualified for Enhanced Training Support for SMEs$32.67
Others (and Repeat Students)$0.00