Preparing Submission Dossier and Pre-reviews
Our team works to prepare or draft all documents and information in Chinese required by CFDA, and per your authorization, submit the application dossier for your product registration on your behalf. With good connection and product specific experience, we do pre-submission communication with CFDA officials, experts and reviewers to ensure the review and approval will be going smoothly.   

Our regulatory team has 15 years long experience with CFDA registration submissions, in particularly has recently made many new successful submissions since the enforcement of the new regulations from 2014. Our experience and knowledge are concentrated on several product sectors mainly including (but not limited to):

• Cardiac vascular devices
• Electronic physiological devices
• Medical imaging equipment
• Radiological and particle tumor therapy equipment
• Some implantable and disposables, 
• IVDs, and Analyzer
• Other surgical and electronic medical instrument.