JAPAN: OK MDSAP report starting from 1st April 2022
Japan’s Ministry of Health, Labour, and Welfare (MHWL) has updated its processes and procedures in order to officially accept MDSAP reports [...]
29 03 2022
29 03 2022
28 03 2022
28 03 2022
CANADA: updates fees for Medical Devices starting from 1st April 2022
Based on the “Fees in Respect of Drugs and Medical Devices Order”, Health Canada published the updated fees for Medical Devices [...]
10 03 2022
10 03 2022
How to market Medical Devices in Switzerland?
As is now widely known, as of 26th May 2021, Switzerland became a Third Country for the EU, following Medical Devices [...]
24 02 2022
24 02 2022
EUROPE: MDCG 2022-2 on clinical evidence for IVD devices published
The Medical Device Coordination Group published the new guidance MDCG 2022-2 “Guidance on general principles of clinical evidence for In Vitro [...]
24 02 2022
24 02 2022
CHINA: registering IVDs and Medical Devices with new templates from 1st January 2022
From 1st January 2022 it is mandatory to use new templates to present the documentation and the technical information necessary to [...]
24 02 2022
24 02 2022
BRAZIL: ANVISA provides an online database for adverse events
In order to reinforce the notification and monitoring system in health surveillance, after the online meeting which took place on 16th [...]
15 02 2022
15 02 2022
THEMA becomes Enterprise member of the international Organization RAPS – Regulatory Affairs Professionals Society
It is with great pride and satisfaction that we announce that THEMA is joining to the international Organization RAPS - Regulatory [...]
19 01 2022
19 01 2022
EU: new standards harmonised for MDR and IVDR regulations
In the first week of January 2022, Commission Implementing Decision (EU) 2022/6 concerning new harmonised standards MDR (EU) 2017/745, and Commission [...]
19 01 2022
19 01 2022
EU: progressive roll-out of the IVDR (EU) 2017/746 adopted by the EU
UPDATE OF 25 JANUARY 2022 OFFICIAL! PUBLISHED IN THE OFFICIAL JOURNAL OF THE EUROPEAN UNION REGULATION (EU) 2022/112 AMENDING REGULATION IVDR (EU) [...]
19 01 2022
19 01 2022
EU: a new Regulation about electronic instructions for use of Medical Devices published
On 15th December 2021, the new Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use of Medical Devices (eIFU) has [...]
