How do I register Medical Devices in the world?

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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 license. In particular, a manufacturer who intends to market Medical Devices in Canada must obtain a product license for class II, III and IV Medical Devices with the competent Authority Health Canada (according to [...]

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 order to register with ANVISA, an INMETRO mark is required for the majority of electroMedical Devices and some non-active devices. This mark is issued by a Certification Body accredited for INMETRO certification. The certification [...]

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 the US. The 510(k) is different from the PMA process, or Premarket Approval, and it’s possible to establish whether the US Regulation requires a 510(K) or a PMA by identifying the most suitable Product [...]

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 role both in pre-market and post-market phase. In particular, the Legal Agent acts as an interface with the competent Authority, he supports the foreign manufacturer to correctly classify the device for the registration procedure [...]

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