Funding for Testing of Medical Devices.
On 17.11.2017 the NMPA (China Food and Drug Administration) published a notice announcing that fee-charging tests (also referred to as sponsored tests) are accepted as part of the NMPA registration of medical devices (No. 2017-187). In April 2017, the MOF (Ministry of Finance) had abolished most test fees for foreign products, resulting in a bottleneck due to laboratories going on strike. This policy evidentially failed and by re-introducing the option of fee-charging tests, a compromise between the State Council, NMPA and test laboratories is attempted. First laboratories have started to provide both test options. However, there are two uncertainties regarding fee-charging tests: Firstly, the timeline is unpredictable because the NMPA failed to specify a timeline in their regulation. Secondly, a failed test will result in the termination of the test and, subsequently, force the manufacturer to initiate a new test application.
For further information on this topic please contact:
Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956info@cisema.de
www.cisema.com
