Resource Library for Medical Device Professionals

10 total results. Show all resources.

Learn about the regulatory structure in China and major medical device regulations.view all

Market Data | 1 web page

This chart illustrates the steps in the China CFDA medical device approval process and includes a timeline of expected

Process Chart | 2 pages

Thinking about entering the Chinese market for the first time? Understanding the CFDA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.view all

Market Data | 1 page

Interested in selling your medical device or IVD in China? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.view all

Service Overview | Varies

China has one of the world's largest medical device markets. Medical device manufacturers see sales opportunities in China, but the regulatory process can be challenging. Interested in learning how to tap into this market? Thwatch now

Video | 4 min

This white paper discusses how to register your medical device with the CFDA in

White Paper | 8 pages

A comprehensive list of medical device regulations in China with links to the original documents.view all

Device Regulation | Downloadable PDFs

A brief look at China's medical device market, including potential opportunities and obstacles for manufacturers.view all

Market Data | 1 web page

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated

Process Chart | Interactive Page

Read by 50,000+ device professionals worldwide. Stay updated on changes to global medical device regulations.view all