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 devices
Select 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