Do you need assistance in NMPA (CFDA) consultation before initiating your registration? In the areas where it is not clearly defined, it is better to double check your registration questions and strategies with NMPA during your pre-submission phase. With a team of bilingual seasoned staff located in our Beijing office, down the street from national NMPA office, ChinaMed Device, LLC is well positioned to provide NMPA Onsite Consultation service to overseas medical device & IVD manufacturers. In addition, as an NMPA certified legal agent, we can represent overseas companies.
ChinaMed Device, LLC can help you research and prepare the questions, and get feedback from NMPA reviewers. You can ask questions related to the registration process ranging from registration category, pathway strategy, technical standards and local type testing, clinical trial endpoint, overseas clinical data, etc. ChinaMed Device, LLC will schedule an appointment, submit questions and obtain feedback.
Please email info@ChinaMedDevice.com, if you are interested in face-to-face consultation with NMPA reviewers.
Our services include:
- Prepare dossiers for NMPA onsite consultation
- Prepare Authorization letter
- Prepare and Research Question list
- Review and research Supporting documents
- Internal review and discussion
- Review product IFU, clinical data, technical file, etc.
- Conduct meetings with clients
- Translate English documents to Chinese
- Schedule the appointment with NMPA reviewer
- Face to face meeting with the NMPA reviewer to talk about the questions
- Obtain and translate NMPA feedback for client
- Address follow up questions in response to NMPA reviewer’s feedbacks
For more information about NMPA Onsite Consultation, please email info@ChinaMedDevice.com.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.