CIRS Released the Guideline on Market Access for Medical Device in China


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.

Content Covered

  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

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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.

Contact Us
CIRS China

Ms Yolanda Yan (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032

CIRS Europe

Bryan Zhou
Tel:  +353 (1)477 3710


CIRS Korea
Mr. Junho Lee 
Tel: +82 2 6347 8801