webinar_medical-device-market-authorisation

Monday, 11 September 2023 / Published in Medical Device, News, NMPA Registration in China, Webinars

Cisema presenting at FORUM Institut: Medical device marketing authorisation for advanced – Masterclass China

Cisema is delighted to hold a Masterclass with the FORUM Institut on December 5-6, 2023. The total 6 hours of live webcast will provide detailed updates about recent regulatory changes in China – including the new medical device law which came into force in 2021 and continues to generate substantial new subsidiary regulation. Our local experts will also take you through the steps on how to perfect your pre-market registration (PMR) and post-market surveillance (PMS) in China.

Topics

Update your regulatory knowledge
Pre-Market Registration: Minimalise your efforts and costs
Acceptance of European registration tests
Clinical pathways: From feasibility study report to a clinical trial
Perfect your cooperation with your NMPA legal agent
Chinese IFU and label

Target audiences

The webcasts are aimed at specialists and managers in the medical device and IVD industry who are managing medical device marketing authorisation in China. Good knowledge of the Chinese medical device market and its legal framework is an important prerequisite. This online course is of particular interest for the following departments:

Regulatory, clinical and quality affairs
Strategy & corporate development
Product management
Distribution and sales

Basic knowledge on medical device marketing authorisation in China is a prerequiste for the training.

Key takeaways

Up-to-date knowledge of the registration authorities in China.
Optimisation of pre-market registration (PMR) with minimal effort and cost.
Understanding the acceptance of European regulatory testing in China.
Insights into clinical pathways from feasibility study report to clinical trial.
Improved cooperation with the NMPA legal representative.
Information on the Chinese Instructions for Use (IFU) and label requirements.

Details

Date: December 5-6, 2023 (Tuesday & Wednesday)

Time: 9-12 AM CET

Language: English

Agenda

Day 1: Pre-Market Registration (PMR)

Products Technical Requirement (PTR): How to write the PTR to minimalize the efforts and costs of change management
Registration tests: What must be done in China and what can be done in your own country
Clinical pathways
- From feasibility study report (FSR) to a clinical evaluation report (CER) to a clinical trial: How to find the best pathway and strategy for your individual product?
In-depth analysis: How to accelerate the complete process of registration.

Day 2: Post-Market Surveillance (PMS)

Legal agent: What must they do for you in China and how can you cooperate
Chinese instruction for use (IFU) and label: Who is responsible and how to manage
Change management: Systematic analyzation of different change types and examples
Random sampling test in China: Facts and trends
Adverse Event (AE): How can you establish a system to manage AE

Questions and discussions are explicitly welcome. Take advantage of the interactive opportunity to talk directly to local experts during the Q&A sessions.

At the end of the webcasts, we have prepared an online test for you to test your knowledge. Once you have taken this test, you will have online access to your certificate.