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:
lAssist the manufacturer to determine product classification
lDetermine the applied standards and test requirements
lPrepare technical documents or design materials, or review your existing documents.
lReview existing marketing materials, labels and user instruction information to ensure compliance and consistency
lVerify compliance with essential requirements
lPrepare clinical/performance evaluation report based on the provided clinical data
lImplement, revise and maintain a quality management system that can meet European and other international requirements (usually ISO13485)
lRisk analysis and management (ISO 14971)
lDevelop vigilance system and post-marketing monitoring procedures
lProvide EU authorized representative services to the manufacturers that do not have a physical office in Europe
lSupport the manufacturer to communicate with Notified Body