Posts tagged with "technical documentation"

12. December 2019
In the MDCG 2019-13 the EU Commission publishes further details on the sampling of the technical documentation for review by the Notified Body during the conformity assessments of Medical devices and IVDs. The guidance explains how to identify product categories ( (for Class IIa and Class B) and generic product groups (for Class IIb and Class C) . Manufacturers will need to utilize two "coding" systems: The MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185, which is...

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...

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.

21. August 2018
Health Canada is introducing a new structure for the submission of device license information of class III and IV products following the INDRF Guidance on nIVD(MA)ToC.