|
|||||||||||||||||||
|
|
|||||||||||||||||||
 |
|||||||||||||||||||
| Home > Regulatory China > Medical Device Importation | |||||||||||||||||||
|
IVD Importation
IVD that has been approved by its country of origin's regulatory entity can apply for importation into China as a clinical test. However, IVD products that are used for research (RUO agents) do not need to go through the registration process. For clinically used IVDs, importation requires am importation certificate issued by the SFDA. The imported products are classified within three classes, and different categories have different requirements with respect to clinical trials and the application process.  Guideline Downloads 
|
NovoTek keeps close communication with government bodies related to healthcare marketing including MOH, SFDA, NDRC,CDE and MHRS.
Every single decision is made based on overall consideration of various aspects of regulatory requirements to ensure lowest risk and highest efficiency.
Incorporated marketing design also include factors from pricing, insurance coverage and government tender process
|
|||||||||||||||||
Home ⎪ About Us ⎪R&D Services ⎪ Pharmaceutical Marketing ⎪ Medical Device Marketing ⎪ Regulatory China ⎪
Copyright © 2002–2013 NovoTek. All rights reserved.
|
|||||||||||||||||||
