China has one of the largest medical device markets in the world. In the end of 2018, there are nearly 1.4 billion people in the mainland of China. In the meantime, the aging population of China is accelerating. The population of the country's population aged 60 and over was 240.9 million, accounting for 17.3% of the total population, of which 158.31 million were 65 years of age and older, accounting for 11.4% of the total population. Thus, the demand of medical devices, especially for the aged, is increasing rapidly and global medical device companies will acquire huge benefits after entering Chinese markets. However, the regulations of medical device in China are accelerated to be optimized and improved. If an overseas medical device company plans to export its medical devices to China, it will takes a long time to learn and understand Chinese regulations, including the priority it can apply for.
Now we issued the “Guideline on Market Access for Medical Device in China” for overseas medical device company. The purpose of this guideline is to list all key points overseas companies may consider and practical information for each points.
• China Regulation Overview
• MAH and Regional Special Policy
• Pre-registration Guideline
• Clinical Evaluation Guideline
• Registration Process and Guideline
• Fast Track Introduction
• Post-market Guideline
How to Get the Guideline on Market Access for Medical Device in China
Clink here to download the free preview of Guideline on Market Access for Medical Device in China version 2019.
CIRS Medical Device Business Unit is a professional team which has a long-term commitment to researching product technology, laws and regulations and industry police of domestic and overseas medical devices. With professional and technical experiences, multiple resources and global network, medical device BU assists domestic and overseas medical device enterprises with a comprehensive service chain and one-stop solution in medical devices regulation and technical consulting service.