NMPA Regulatory & Registration Services
Overcome China’s regulatory hurdle by leveraging Kojima’s expertise and relationships.
Expedite Your Time To Market
Kojima partners with a proven CRO & NMPA registration company to ensure your medical device receives its sales certification as soon as possible.
Kojima provides the following China regulatory services:
Plan The Best Way Forward
Define Regulatory Strategy
After reviewing your device, Kojima confirms the correct device classification and identifies any obstacles & opportunities the device will face. This includes:
- Design Issues
- Additional Required Testing
- IP Protection
- Fast Track Approvals (Innovation)
Lastly, we review the estimated timeline and costs to get your product to market.
Meeting China's Standards
Conduct Required Testing
From simple type testing to more complicated animal and clinical trials, Kojima has the resources and connections to complete all required testing & clinical services.
This includes:
- Test Protocol Design
- Patient Screening
- Writing Services
- Clinical Trial Follow-Up
Taking The Registration Lead
From Start To Finish
Throughout the registration process, Kojima takes a proactive lead to shorten the registration timeline as much as possible.
From start to finish, Kojima manages the registration process with two clear goals.
- 1. Minimize Time To Market
- 2. Maximize Control For Clients
By valuing long-term relationships with out clients, we ensure that the registration process is done correctly with as much control and flexibility given to the device manufacturer.
