Topics Covered:
In a nutshell, during the webinar, our presenter – Allan Zhang discussed the following topics:
- China NMPA requirements for SaMD registration
- SaMD product classification and application numbers
- Relevant standards and local type testing requirements for SaMD
- Clinical evaluation pathway for SaMD
- Registration documents requirement for SaMD
- Guideline for software product registration overview
- Guideline for SaMD Cybersecurity overview
- NMPA requirements for SaMD version upgrade
- FAQs
As a continuous practice, Freyr organizes more webinar sessions related to Regulatory aspects in Life Sciences. We presume you would like to be a part of all those sessions. If yes, let us have an opportunity to inform you about our next session.
Ji Yun (June) Jung is a Client Partner and Business Development Manager at Freyr solutions. With eight (08)+ years' experience in biotechnology field, June has profound experiences in handling the business aspects of pharmaceutical, medical device, and the consumer (cosmetics, food and food supplements, and chemical products) industries. She currently handles the needs of the Korean market.
With 10 years experience of medical device registration. Allan has rich experience in active and non-active medical device, guiding numerous foreign and local manufacturing companies and helping them to get more than 100 certificates approved by NMPA. He had participated in drafting CMDE guideline and industry standards. He can guide manufacture with fast and compliant registration strategy.
Host
Ji Yun (June) Jung
Assistant Manager- Business Development
Presenter
Allan Zhang
Manager- Medical Devices, Freyr China