CHINA: discover the secrets of the 2016 guideline on X-ray devices!
Knowing how to register a device in China is more and more difficult: finding texts is an mission impossible and even [...]
13 07 2017
13 07 2017
12 07 2017
12 07 2017
The renewal timetable: watch out for deadlines
The first half of the year is about to end and it is better to start thinking about registrations, notifications, or [...]
12 07 2017
12 07 2017
UKRAINE: get to know more about medical device compliance procedure
On July 1, 2015 marketing authorization requirements for Medical Devices in Ukraine have changed. The previous registration system has been replaced [...]
29 09 2016
29 09 2016
USA: wake up… FDA is speaking!
Speaking of novelties and regulatory updates, we can certainly assert that the FDA never sleeps! Agency is always frenetically busy in [...]
24 04 2016
24 04 2016
How to effectively implement the Unified Device Identification (UDI) FDA program
The UDI application required by the FDA may be considered an easy and fast task, which simply requires affixing a barcode [...]
24 01 2016
24 01 2016
FDA audits: what are the effects on the company?
If the company is placing Medical Devices on the US market, the FDA may carry out an establishment inspection in order [...]
