South America
ANVISA recently introduced a new requirement for medical device manufacturers who will be conducting clinical investigations. Sponsors will need to submit Medical Device Clinical Dossier clinical (DICD). This resolution will be applicable to all clinical trials with...
South America
Brazil is the largest medical device market in Latin America, and has an established but complex regulatory system. Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA). ANVISA in its effort to streamline medical device...
Africa
You don’t ask your sales team to offer you regulatory guidance. So why do you rely on your distributor to handle all your regulatory burden? First of all, it’s not so simple to register medical device abroad. Access to customers sometimes requires...
Africa
Introduction The client is a Fortune 100 company that manufactures a surgical device among other products. Their objective was to launch their surgical device in Russia as soon as possible. Business Challenge The client has a local office in Russia. They still decided...
Africa
Imagine you are following a controversial political scandal. What would you do? Watch the news unfold on only one channel, or pick up the TV remote and jump between multiple channels? Collecting accurate, reliable and in-depth data is the most crucial goal for...
Africa
General Context UDI is a Unique Device Identifier in the form of a unique number or alphanumeric code. It consists of plain text and AIDC (only readable via machine) Issued by an FDA-accredited issuing agency. UDI is granted for 3 years and can be renewed upon...
