IVDs

Cisema will jointly present a webinar session with the Chamber of Commerce (IHK) Lübeck on August 29 to provide an overview of the market potential and registration of medical devices and IVDs in China.

The session will be interactive, and will go through many interesting topics:

• The Chinese market
• The authorities and other players in China
• The admission requirements and responsibilities
• Legal representation of the manufacturer - Legal Agent
• Post Market Surveillance
• Recent changes in the registration process
• New approaches to simplified market access in certain regions

Date: August 26

Time: 9:00 am – 11:00 am

Price: Free of charge

Open for public

Our speaker: Markus Roepke

Language: German

Online Registration Link

On 20.12.2019, the China NMPA (National Medical Products Administration) announced (No.91-2019) that it would add 148 medical devices and 23 in-vitro diagnostic reagents to the clinical trial exemption list, as well as to revise the names and descriptions of 48 medical devices and 4 in-vitro diagnostic reagents. Medical devices and in-vitro diagnostic reagents on the clinical trial exemption list won’t require completion of clinical trials in order to achieve NMPA certification.This new clinical trial exemption list is effective since the date of announcement on 20th December.Feel free to contact us if you would like to know what products were included in the clinical trial exemption list for medical devices, and the clinical trial exemption list for IVDs.