our strength

i Access Consulting provides a wide-range of regulatory services on Medical device and IVD products registration in Japan PMDA and China NMPA.

i Access Consulting has extensive knowledge and experience in medical device and IVD products registration in Japan and China, and a good relationship with Japan PMDA, Notified body and China NMPA.

　 Thinking about entering Japan and China markets for the first time? Understanding the PMDA/NMPA regulatory requirements can be overwhelming and confusing. i Access Consulting assembled a packet that includes the basic information you need before deciding to enter Japan market.

With a team of experienced RA/QA consultants working across Japan and China, we can develop and implement global regulatory strategies to accelerate your specific commercialization efforts—ultimately getting you to market faster so you may make a more immediate impact on patient safety and healthcare.

　　　Driven by our global regulatory expertise and in-depth therapeutic knowledge, i Access Consulting offers only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.

With our medical device consulting approach, you maintain project control while gaining the benefit of on-demand external support—whether the goal is to extend your in-house capabilities or obtain access to the specialized expertise you need.