CE-marking

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