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Medical Network News on June 4
Official announcement: List of 109 innovative medical devices
On June 1, the State Food and Drug Administration issued several articles, including the list of innovative medical devices approved by the State Food and Drug Administration.
It is reported that in order to implement the spirit of the country’s deepening reform and encouraging innovation, the “Special Approval Procedures for Innovative Medical Devices (Trial)” was formulated in February 2014; subsequently, to implement the “Regarding Deepening Review and Approval” issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council.
Opinions on Encouraging the Innovation of Drugs and Medical Devices by Institutional Reform (Ting Zi [2017] No.
42), which encourages R&D and innovation of medical devices, promotes the promotion and application of new medical device technologies, and promotes the high-quality development of the medical device industry.
In 2018, the "Special Review Procedure for Innovative Medical Devices" was organized and revised.
Opinions on Encouraging the Innovation of Drugs and Medical Devices by Institutional Reform (Ting Zi [2017] No.
42), which encourages R&D and innovation of medical devices, promotes the promotion and application of new medical device technologies, and promotes the high-quality development of the medical device industry.
In 2018, the "Special Review Procedure for Innovative Medical Devices" was organized and revised.
The Medical Device Evaluation Center of the State Drug Administration (hereinafter referred to as "CMDE") as the implementing unit, through cooperation with the Chinese Society of Biomedical Engineering and the Chinese Society for Biomaterials, with the help of the society’s rich expert resources, select authoritative experts and scholars in relevant research fields to pass The meeting method put forward review opinions.
According to statistics, during the period 2018-2020 alone, CMDE commissioned two societies to organize more than 520 reviews of innovative medical device experts.
At the same time, CMDE has established a joint review mechanism to conduct collective research on expert review opinions and related issues with the Medical Device Registration Department and the Society in the form of member working meetings.
As of May 26, 2021, CMDE has received 1,554 special review applications for innovative medical devices, including 316 innovative program products, and 109 approved products (see the end of the text for the list).
At the same time, CMDE has established a joint review mechanism to conduct collective research on expert review opinions and related issues with the Medical Device Registration Department and the Society in the form of member working meetings.
As of May 26, 2021, CMDE has received 1,554 special review applications for innovative medical devices, including 316 innovative program products, and 109 approved products (see the end of the text for the list).
After the implementation of the new "Regulations", will it affect the declaration of innovative devices?
On December 21, 2020, the State Council executive meeting reviewed and approved the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft).
" On February 9, 2021, the State Council officially promulgated the "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)", which will be officially implemented on June 1, 2021, marking my country's medical device review and approval reform has entered a new stage.
" On February 9, 2021, the State Council officially promulgated the "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)", which will be officially implemented on June 1, 2021, marking my country's medical device review and approval reform has entered a new stage.
There may be many people wondering whether the innovative medical device declaration will have an impact after the "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)" is implemented?
Indeed, the new version of the "Regulations" clearly proposes that the supervision and management of medical devices should follow the principle of scientific supervision.
Previously, the Device Evaluation Center participated in the first batch of research including the safety and effectiveness evaluation of artificial intelligence medical devices, the methodological research of real-world data for clinical evaluation of medical devices, the technical evaluation research of medical device combination products, and the supervision of new medical device materials.
Four key project research work.
Previously, the Device Evaluation Center participated in the first batch of research including the safety and effectiveness evaluation of artificial intelligence medical devices, the methodological research of real-world data for clinical evaluation of medical devices, the technical evaluation research of medical device combination products, and the supervision of new medical device materials.
Four key project research work.
In the next step, CMDE will consolidate the results of the reform of the review and approval system, do a good job in the implementation of the new "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)", continue to promote innovative medical device reviews and regulatory scientific research, and focus on the high quality of the medical device industry Develop demand and focus on providing services to solve problems such as "stuck necks", in order to promote the high-quality development of China's independent innovative medical device industry, help China's high-end medical device products to be listed as soon as possible on a safe and effective basis, and meet the people's medical and health needs Make a positive contribution.
Medical Network News on June 4
Official announcement: List of 109 innovative medical devices
On June 1, the State Food and Drug Administration issued several articles, including the list of innovative medical devices approved by the State Food and Drug Administration.
It is reported that in order to implement the spirit of the country’s deepening reform and encouraging innovation, the “Special Approval Procedures for Innovative Medical Devices (Trial)” was formulated in February 2014; subsequently, to implement the “Regarding Deepening Review and Approval” issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council.
Opinions on Encouraging the Innovation of Drugs and Medical Devices by Institutional Reform (Ting Zi [2017] No.
42), which encourages R&D and innovation of medical devices, promotes the promotion and application of new medical device technologies, and promotes the high-quality development of the medical device industry.
In 2018, the "Special Review Procedure for Innovative Medical Devices" was organized and revised.
Opinions on Encouraging the Innovation of Drugs and Medical Devices by Institutional Reform (Ting Zi [2017] No.
42), which encourages R&D and innovation of medical devices, promotes the promotion and application of new medical device technologies, and promotes the high-quality development of the medical device industry.
In 2018, the "Special Review Procedure for Innovative Medical Devices" was organized and revised.
The Medical Device Evaluation Center of the State Drug Administration (hereinafter referred to as "CMDE") as the implementing unit, through cooperation with the Chinese Society of Biomedical Engineering and the Chinese Society for Biomaterials, with the help of the society’s rich expert resources, select authoritative experts and scholars in relevant research fields to pass The meeting method put forward review opinions.
According to statistics, during the period 2018-2020 alone, CMDE commissioned two societies to organize more than 520 reviews of innovative medical device experts.
At the same time, CMDE has established a joint review mechanism to conduct collective research on expert review opinions and related issues with the Medical Device Registration Department and the Society in the form of member working meetings.
As of May 26, 2021, CMDE has received 1,554 special review applications for innovative medical devices, including 316 innovative program products, and 109 approved products (see the end of the text for the list).
At the same time, CMDE has established a joint review mechanism to conduct collective research on expert review opinions and related issues with the Medical Device Registration Department and the Society in the form of member working meetings.
As of May 26, 2021, CMDE has received 1,554 special review applications for innovative medical devices, including 316 innovative program products, and 109 approved products (see the end of the text for the list).
After the implementation of the new "Regulations", will it affect the declaration of innovative devices?
On December 21, 2020, the State Council executive meeting reviewed and approved the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft).
" On February 9, 2021, the State Council officially promulgated the "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)", which will be officially implemented on June 1, 2021, marking my country's medical device review and approval reform has entered a new stage.
" On February 9, 2021, the State Council officially promulgated the "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)", which will be officially implemented on June 1, 2021, marking my country's medical device review and approval reform has entered a new stage.
There may be many people wondering whether the innovative medical device declaration will have an impact after the "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)" is implemented?
Indeed, the new version of the "Regulations" clearly proposes that the supervision and management of medical devices should follow the principle of scientific supervision.
Previously, the Device Evaluation Center participated in the first batch of research including the safety and effectiveness evaluation of artificial intelligence medical devices, the methodological research of real-world data for clinical evaluation of medical devices, the technical evaluation research of medical device combination products, and the supervision of new medical device materials.
Four key project research work.
Previously, the Device Evaluation Center participated in the first batch of research including the safety and effectiveness evaluation of artificial intelligence medical devices, the methodological research of real-world data for clinical evaluation of medical devices, the technical evaluation research of medical device combination products, and the supervision of new medical device materials.
Four key project research work.
In the next step, CMDE will consolidate the results of the reform of the review and approval system, do a good job in the implementation of the new "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)", continue to promote innovative medical device reviews and regulatory scientific research, and focus on the high quality of the medical device industry Develop demand and focus on providing services to solve problems such as "stuck necks", in order to promote the high-quality development of China's independent innovative medical device industry, help China's high-end medical device products to be listed as soon as possible on a safe and effective basis, and meet the people's medical and health needs Make a positive contribution.
Medical Network News on June 4
Official announcement: List of 109 innovative medical devices
Official announcement: List of 109 innovative medical devices On June 1, the State Food and Drug Administration issued several articles, including the list of innovative medical devices approved by the State Food and Drug Administration.
It is reported that in order to implement the spirit of the country’s deepening reform and encouraging innovation, the “Special Approval Procedures for Innovative Medical Devices (Trial)” was formulated in February 2014; subsequently, to implement the “Regarding Deepening Review and Approval” issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council.
Opinions on Encouraging the Innovation of Drugs and Medical Devices by Institutional Reform (Ting Zi [2017] No.
42), which encourages R&D and innovation of medical devices, promotes the promotion and application of new medical device technologies, and promotes the high-quality development of the medical device industry.
In 2018, the "Special Review Procedure for Innovative Medical Devices" was organized and revised.
Drugs medical equipment medicines medicines Medical Devices Medical DevicesOpinions on Encouraging the Innovation of Drugs and Medical Devices by Institutional Reform (Ting Zi [2017] No.
42), which encourages R&D and innovation of medical devices, promotes the promotion and application of new medical device technologies, and promotes the high-quality development of the medical device industry.
In 2018, the "Special Review Procedure for Innovative Medical Devices" was organized and revised.
The Medical Device Evaluation Center of the State Drug Administration (hereinafter referred to as "CMDE") as the implementing unit, through cooperation with the Chinese Society of Biomedical Engineering and the Chinese Society for Biomaterials, with the help of the society’s rich expert resources, select authoritative experts and scholars in relevant research fields to pass The meeting method put forward review opinions.
According to statistics, during the period 2018-2020 alone, CMDE commissioned two societies to organize more than 520 reviews of innovative medical device experts.
At the same time, CMDE has established a joint review mechanism to conduct collective research on expert review opinions and related issues with the Medical Device Registration Department and the Society in the form of member working meetings.
As of May 26, 2021, CMDE has received 1,554 special review applications for innovative medical devices, including 316 innovative program products, and 109 approved products (see the end of the text for the list).
At the same time, CMDE has established a joint review mechanism to conduct collective research on expert review opinions and related issues with the Medical Device Registration Department and the Society in the form of member working meetings.
As of May 26, 2021, CMDE has received 1,554 special review applications for innovative medical devices, including 316 innovative program products, and 109 approved products (see the end of the text for the list).
After the implementation of the new "Regulations", will it affect the declaration of innovative devices?
After the implementation of the new "Regulations", will it affect the declaration of innovative devices? On December 21, 2020, the State Council executive meeting reviewed and approved the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft).
" On February 9, 2021, the State Council officially promulgated the "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)", which will be officially implemented on June 1, 2021, marking my country's medical device review and approval reform has entered a new stage.
" On February 9, 2021, the State Council officially promulgated the "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)", which will be officially implemented on June 1, 2021, marking my country's medical device review and approval reform has entered a new stage.
There may be many people wondering whether the innovative medical device declaration will have an impact after the "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)" is implemented?
Indeed, the new version of the "Regulations" clearly proposes that the supervision and management of medical devices should follow the principle of scientific supervision.
Previously, the Device Evaluation Center participated in the first batch of research including the safety and effectiveness evaluation of artificial intelligence medical devices, the methodological research of real-world data for clinical evaluation of medical devices, the technical evaluation research of medical device combination products, and the supervision of new medical device materials.
Four key project research work.
Previously, the Device Evaluation Center participated in the first batch of research including the safety and effectiveness evaluation of artificial intelligence medical devices, the methodological research of real-world data for clinical evaluation of medical devices, the technical evaluation research of medical device combination products, and the supervision of new medical device materials.
Four key project research work.
In the next step, CMDE will consolidate the results of the reform of the review and approval system, do a good job in the implementation of the new "Regulations on the Supervision and Administration of Medical Devices (2021 Edition)", continue to promote innovative medical device reviews and regulatory scientific research, and focus on the high quality of the medical device industry Develop demand and focus on providing services to solve problems such as "stuck necks", in order to promote the high-quality development of China's independent innovative medical device industry, help China's high-end medical device products to be listed as soon as possible on a safe and effective basis, and meet the people's medical and health needs Make a positive contribution.
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