20. October 2020
The newly published Inforgraphic on "Actor roles and SRN" explains the future structure of the Single Registration Number (SRN).
20. October 2020
Following the information given by the EU-Commission on the new website with Information on the EUDAMED database the first of 6 modules in the EUDAMED system will be available as of 2020-12-01. This will allow the Actors to register themselves prior to the DoA. It will be the first step to generate the Single Registration Number SRN that is required for several documents such as the declaration of conformity etc.. Further the website indicates theta as of December 1st 2020 the EUDAMED website...
20. October 2020
The commission published a new website with information concerning the EUDAMED Database. On the website potential users of the EUDAMED database will find further information concerning: Single Registration Number (SRN) Actor registration request process Documents to provide with the actor registration request User guide for economic Operators Technical documentation (for the EUDAMED database not for devices) The linked documents will give organizations detailed knowledge of what they need to...
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.
02. January 2019
The Malaysian "Medical Device Authority" (MDA) made the second version of the Registration database available to public which is called MEDC@ST 2.0. All existing registration made prior to 2018-12-21 are automatically transferred into the new database, those ongoing or still under review will be transferred after final approval of the submission.
22. January 2018
Anvisa expands the validity of registrations for Brazil from previously 5 years to now 10 years!