Are you a manufacturer of medical device and/or in vitro diagnostic medical device?
Do you have plans to enter into German/EU market?
NIC team would be happy to provide you regulatory support on CE marking and EU authorized representative service.
NMPA, Registration NMPA
With extensive medical resources in China and a leading team of medical experts, NIC is able to provide regulatory service for registration and approval with NMPA, China.
Our team will:
l Assist the manufacturer to determine product classification
l Determine the applied standards and test requirements
l Prepare technical documents or design materials, or review your existing documents.
l Review existing marketing materials, labels and user instruction information to ensure compliance and consistency
l Verify compliance with essential requirements
l Prepare clinical/performance evaluation report based on the provided clinical data
l Implement, revise and maintain a quality management system that can meet European and other international requirements (usually ISO13485)
l Risk analysis and management (ISO 14971)
l Develop vigilance system and post-marketing monitoring procedures
l Provide EU authorized representative services to the manufacturers that do not have a physical office in Europe
l Support the manufacturer to communicate with Notified Body