Interpretation and Analysis of Relevant Policies of China's Medical Device Industry in 2020

—— Original title: Relevant policies and interpretation analysis of China's medical device industry in 2020 "regulation+encouragement" promotes the healthy and orderly development of the industry

"Supervision+encouragement" promotes the healthy and orderly development of the medical device industry

As one of the high-tech industries in China, the medical device industry has frequent policies on encouraging the development and strengthening the supervision of the industry in order to promote the healthy and orderly development of the industry. For example, in August 2019, the State Food and Drug Administration issued the "Notice on Expanding the Pilot Work of the Medical Device Registration System" to accelerate the innovation and development of the medical device industry;

For another example, in April 2020, the State Food and Drug Administration issued the Notice on Issuing the Guidelines for Medical Device Registrants to Monitor Adverse Events, so as to strengthen the guidance and supervision of medical device registrants and filers. On the whole, national policies have helped the healthy and orderly development of the medical device industry in terms of "supervision+encouragement".

1,Analysis of China's medical device product management system

According to the Regulations on the Supervision and Administration of Medical Devices, China has implemented a strict filing and registration management system for the production and circulation of medical devices. Among them, the first type of medical devices are subject to product filing management, and the second and third types of medical devices are subject to product registration management.

2,Summary and analysis of relevant policies of China's medical device industry

As one of the high-tech industries in China, the medical device industry has frequent policies on encouraging the development and strengthening the supervision of the industry in order to promote the healthy and orderly development of the industry. For example, in August 2019, the State Food and Drug Administration issued the "Notice on Expanding the Pilot Work of the Medical Device Registration System" to accelerate the innovation and development of the medical device industry;

For another example, in April 2020, the State Food and Drug Administration issued the Notice on Issuing the Guidelines for Medical Device Registrants to Monitor Adverse Events, so as to strengthen the guidance and supervision of medical device registrants and filers. From 2017 to the beginning of June 2020, the regulatory, incentive and planning policies for the medical device industry are as follows:

3,Interpretation and analysis of key policies of China's medical device industry

—— Supervision category

In order to guide medical device registrants and filers to establish and improve the monitoring system of adverse events of medical devices, promote the monitoring of adverse events of medical devices, and timely and effectively control the risks after medical devices go on the market, in April 2020, the State Food and Drug Administration issued the Guidelines for Medical Device Registrars to Monitor Adverse Events, the main contents of which are as follows:

-Encourage class

In the context of the rapid development of China's pharmaceutical medical device industry, in order to promote the structural adjustment and technological innovation of the pharmaceutical medical device industry and improve the industrial competitiveness, in October 2017, the Central Committee of China and the State Council issued the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices,The main opinions are as follows:

In August 2019, in order to implement the "Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Medical Devices", the State Drug Administration decided to further expand the pilot work of the medical device registrant system on the basis of the pilot work of the medical device registrant system in Shanghai, Guangdong and Tianjin Free Trade Zones,The specific contents are shown in the following table:

For the above data sources and analysis, please refer to the Analysis Report on Market Demand Forecast and Investment Strategic Planning of China's Medical Device Industry by Prospective Industry Research Institute,At the same time, Prospective Industry Research Institute provides industrial big data, industrial planning, industrial declaration, industrial park planning, industrial investment and other solutions.