When is the Notified Body’s intervention needed?
The manufacturer originally classifies its own devices. If the risk class established is the class I (lower risk), a Notified Body [...]
19 07 2017
19 07 2017
19 07 2017
19 07 2017
When do I have to appoint an Authorized Representative?
If a device manufacturer is established outside the European Union, it’s necessary to appoint an Authorized Representative by a written power [...]
19 07 2017
19 07 2017
How can I establish a medical device risk class ?
Medical Devices are classified according to their complexity and potential risk for the patient. In accordance with the current Regulation, four [...]
19 07 2017
19 07 2017
Marketing in Canada: what is the difference between MDAL and MDEL?
MDAL and MDEL are the acronyms of Medical Device Application License and Medical Device Establishment License, respectively product license and establishment [...]
18 07 2017
18 07 2017
Marketing in Brazil: do I need to get the INMETRO mark?
Medical Device marketing authorization in Brazil involves both registration with ANVISA and, in some cases, a product certification process. Particularly, in [...]
18 07 2017
18 07 2017
What is the 510(k)?
The 510(k), or Premarket Notification, is the FDA most frequently required process to medical device manufacturers to market their devices in [...]
18 07 2017
18 07 2017
Marketing in China: what is the Legal Agent responsible for?
In order to market Medical Devices in China, manufacturers shall appoint a Legal Agent established in China who plays an important [...]
18 07 2017
18 07 2017
How do I select the country where I want to sell my devices?
Supporting data are essential to select the target country, that is the country where I intend to sell my devices. The [...]
18 07 2017
18 07 2017
How do I find the information I need to sell my devices?
Finding information is the trickiest part. You can collect data from different sources of information, even if you always need to [...]
18 07 2017
18 07 2017
What is the OBL contract?
The term Own Brand Labeling (OBL) refers to the particular procedure that a Medical Devices manufacturer should follow when marketing devices [...]
