Preparing Submission Dossier and Pre-reviews
Our team works to prepare or draft all documents and information in Chinese required by NMPA, 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 NMPA officials, experts and reviewers to ensure the review and approval will be going smoothly.   

Our regulatory team has 25 years long experience with NMPA 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/particle tumor therapy equipment
• Some implantable and disposables, 
• IVDs, and NGS Analyzer
• Other surgical and electronic medical instrument.