Resources

All regulatory process charts are available to download from Regulatory Affairs Management Suite (RAMS).
Log into RAMS or create your free account to download this information.

LOG INTO RAMS

Get unlimited access to the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

NMPA - National Medical Products Administration
The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug
Read More
China NMPA Regulatory Approval Process for Medical Devices
To see their products to the Chinese market, medical device and IVD manufacturers will need to obtain National Medical Products Administration (NMPA
Read More
Medical device registration in China webinar
NMPA medical device registration requirements in China
China represents a vast market for medical devices, but its regulatory system can be difficult to navigate. A recent report published by China’s
Read More
Fill out our short form to request information about China
Get smart about China in 1 hour
If you are thinking about entering the Chinese market for the first time, trying to understand the CFDA regulatory requirements can be overwhelming.
Read More
China Medical Device Market Overview
With over 1.3 billion residents, China has one of the world's largest medical device markets. Medical device manufacturers around the world are
Read More
CHINA – Overview of medical device industry and healthcare statistics
Below you will find basic demographic and healthcare market data on China, plus specific information about the medical device and healthcare
Read More
Learn about the Chinese CFDA regulations which apply to medical devices
China NMPA Medical Device Regulations
Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the NMPA only makes these available in Chinese.
Read More
Download Emergy white paper - China NMPA device registration
China NMPA Medical Device Registration Requirements
Thinking of selling your medical device in China? If so, you need to register your device with China's regulatory authority, the China Food and Drug
Read More