Posts tagged with "CHINA"

01. November 2019
China is step by step implementing an E-submission approach. As of 2019-11-01 applications submitted to NMPA shall be submitted according to the “Technical Guideline on Registration Material Requirements for Electronic Submission System”. (see our News Blog "NMPA published the "Technical Guidance for Submission under the RPS ToC") NMPA as member of the IMDRF prepared this guidance for the e-RPS based on the IMDRF nIVD(MA)ToC. This does not necessarily mean that the applications now need to...

01. October 2019
The regulation that was published by the NMPA and that came into force 2019-10-01 just specifies that UDI regulations are applicable for medical devices as of that date - BUT - the details are missing ! This is the wording of the most important article: 第十八条 本规则自2019年10月1日起施行。分类实施的具体步骤另行制定并 公布。 Article 18 These Rules shall come into force on October 01, 2019. The specific steps for the implementation of the classification will be...

04. July 2019
The Chinese State Drug Administration in conjunction with the National Health and Health Commission issued the "Regulations for the Supervision and Management of Customized Medical Devices " (Order 53 of 2019) that will be effective from January 1, 2020. The Regulation includes a definition of "Personalised medical devices" and separates them into "customised medical devices" and "patient-matched medical device".

06. June 2019
On Mai 31th 2019 the NMPA published a Guidance how to prepare future e-submission for the eRPS System. The new file structure is created following the principles of the IMDR nIVD(MA)ToC and covers the national specialties necessary for registration of medical devices in China.

01. September 2018
As of September 1st 2018 the new name of the organization responsible for Medical devices in China is "National Medical products Administration" (NMPA) replacing the former China Food and Drug Administration (CFDA). The new website of the administration now active. NMPA is an organization under the "State Administration for Market Regulation" (SAMR) that was found in March 2018 integrating the former: State Administration for industry and commerce of the PRC (SAIC) General...

27. March 2018
Following the reform plan of the State Council "China Food and Drug Administration is merged with the NHFPC and the GAQSIQ into the State Market Regulatory Administration.

31. October 2017
The CFDA published a third list of medical devices and IVD that is exempted from mandatory clinical trials. The publication lists 11 Class III products 37 Class II products that will no more require clinical trials in China. The publication 2017年第170号 is only available in Chinese. The first batch issued in 2014 exempted already: 112 Class III Products and 488 Class II products ( 2014年 第12号) and the second batch published as 2016年第133号 further: 92 Class III products 267 Class...

08. August 2017
With the new publication by the CFDA the labelling requirements get stronger...