Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies.
Depending on where you plan to sell your device(s), successful registration may involve substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets.
China Med Device can assist you in registering your medical device products. Our regulatory consultants are diligent in preparing and reviewing medical device registration documents. We will take the following steps to minimize additional documentation requests from the approval body and other delays:
Pre consultation with NMPA reviewer
China Med Device’s bi-lingual and bi-culture team can represent our client and have face-to-face meeting with NMPA reviewers during the submission prepration phase. We can
- Registration, modification, renewal submission & communication
- PTR writing and onsite type testing support
- Software and cyber security documents writing compliant to NMPA requirements
- Innovation, priority & other pathways assessment and submission