We would like to get you all acquainted with our China Expert, Aibang Yuan. An interview where we talk about his expertise, how a normal workday looks like and which trends he observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!
Let's start with a small introduction. Could you tell me something about yourself?
My name is Aibang, I graduated from Nanjing TECH University with a Master's degree. My background is in the area of biology and organic chemistry. For over 4 years, I focus on the type testing, technical documentation preparation, QMS and adverse event monitoring involved in China medical devices registration process.
At present, my main work at Qserve is
- Advice on practical interpretation of NMPA regulations, standards and clinical guidelines
- Planning of type testing scheme & gap analysis on current standards
- Writing technical documents and submission dossier preparation
- Communication with NMPA on their assessments
- Practical operation of adverse event/recall
Which part of your job do you like the most?
Generally speaking, I think every part of my work is similar. If I have to choose one
I prefer “Communication with NMPA on their assessments”. Usually each question from the reviewer is a challenge and will gain more sense of accomplishment after all the questions are solved.
What does a normal workday looks like as a consultant at Qserve?
Our Chinese team members stay in different cities, so online communication is our normal working style, but this does not prevent us from working together to complete the project. In general, the network links everything.
Do you prefer a specific type of medical device?
There are too many types of medical devices, and it is a learning process for me to understand each different type of product. But if you distinguish from the risk levels, I prefer to learn the class Ⅲ medical devices. This kind of device has the most strict supervision and usually faces the most problems, so it can effectively help me predict the potential risk points of other types of devices when they are registered.
Which trends do you see at the moment?
For now, the impact of the COVID-19 and its impact on life is still a hot topic. Vaccines, supplies, devices are all around this.
How do you stay up to date with everything that is happening?
I would recommend to frequently visit the website of China NMPA and to get a subscription to their account in WeChat.
What is your advice for our customers?
Trust. When I say trust, I mean that when clients work with us, mutual trust is very important. Usually our requirements for clients are based on past work experience, so clients need to trust Qserve’s professional judgment and work together to solve the problems during the registration.
Would you like to know more about Aibang? Click here for his full profile.