CE Marking Explained –The European Commission describes the CE Marking as the “Passport to Europe” which allows manufactures to freely circulate their products within the European market.

NMPA-Any manufacturer wishing to sell and use medical devices (including domestic and overseas devices) in China shall register with the corresponding food and drug regulatory authorities.

FDA – Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations.

CE Professional Services- We will act as the legalentity of the competent authorities, perform our duties on behalfof you in accordance with the instructions of Medical Devicesand provide your products with access to the EU market.

NMPA Professional Services – We provide NMPA registration consulting services for domestic and foreign medical device enterprises, and help them compile technical requirements and evaluate clinical products.

FDA Professional Services – Pre 510(k)submission gapanalysis and requirements evaluation, Dossier compilation andFDA 510(k)submission.