October 22, 2020 - October 22, 2020
Date: October 22nd, 2020
Time: 16.00h - 17.15h CET / 10pm - 11.15pm EDT
China’s fast growing medical device market presents numerous opportunities for European companies. However, understanding the practicalities of accessing the market is not simple.
All medical devices entering the Chinese market are required to obtain pre-market approval, known as medical device registration, from the Chinese National Medical Product Administration (NMPA).
The Qserve Group has local offices in China and experienced local staff on the ground to help you get your medical device on the Chinese market, quickly and efficiently.
During this short webinar you will learn about the Regulatory framework for medical devices in China (laws, regulations, guidance, standards, etc.), Involved regulatory bodies (NMPA, CMDE, testing centers, etc.), the device risk classification (I-III, domestic vs imported) and the registration process, dossier requirements and related timelines and cost. Furthermore we will address special requirements for imported devices (e.g. local agent, etc.) and provide an update on recently implemented NNPA requirements.