China science and technology society memo [2017] No. 461
Notice on Collection of Innovative Medical Device Product Catalogue by the Science and Technology Department of Social Development
Relevant units:
In order to further implement the guidance on promoting the healthy development of the pharmaceutical industry (no.11, 2016), increase the publicity of innovative medical devices and promote the sustainable and healthy development of the pharmaceutical industry, we are now starting the selection of innovative medical devices and collecting innovative products from the society.
The products listed in the catalogue of innovative medical devices after review are recommended to be applied and promoted in the demonstration project of domestic innovative medical devices.The relevant matters are hereby notified as follows:
1. Conditions for recommending supplementary products for innovative medical devicesSelect innovative medical device products that meet the following conditions and have obtained product registration certificate in China:
(1) international originality and domestic initiative, with patents for key technologies and core components; Or through technological innovation in functional performance, cost performance, reliability, user experience and other aspects of significant improvement;
(2) it has great clinical application value and promotes the improvement of medical treatment level, and has significant economic and social benefits.
Conditions for recommending supplementary products for innovative medical devices
(1) the only domestic products that are competitive with similar foreign products;(2) obtaining support from national science and technology plans (special projects, funds, etc.);
(3) examination and approval shall be conducted in accordance with the special examination and approval procedure for innovative medical devices (trial) and the preferential examination and approval procedure for medical devices;
(4) the application demonstration project of domestic innovative medical devices has high evaluation and obvious regional economic driving force.
3. Methods of collection and registration
Enterprises in the field of medical devices that meet the above application requirements download and fill in the innovative medical device product information collection form.Please stamp the official seal on the collection form and relevant certification materials and mail them to the office of strategic alliance for technological innovation in the medical device industry.
Also, submit the electronic version to suwn@camdi.org.The deadline for submission is January 30, 2018. If the deadline is overdue, it will not be accepted.
Contact: Su Wenna
Contact number: 010-65499360, 13911737677
Address: room 1101, building 18, jianwai SOHO, middle road, east third ring road, chaoyang district, Beijing
Annex: innovative medical device product information collection form
By attachment
http://www.caai.cn/index.php?s=/home/file/download/id/211.html
Department of social development science and technology, ministry of science and technology
December 28, 2017- Government
- Association