Africa
The Ethiopian Food and Drug Authority (EFDA), Ethiopia’s national authority responsible for medical device regulation, has provided draft guidance regarding proposed changes to the rules and regulations on post-approval changes of medical devices. The appropriate...
Africa
Although medical device companies are not required to comply with ISO 13485:2016 until March of next year, the International Organization for Standardization (ISO) Technical Management Board is contemplating rewriting the quality systems standard. The group that...
Africa
The International Coalition of Medicines Regulatory Authorities (ICRMA) announced on Friday that they are seeking industry experts for a one year project to ensure proper awareness of track and trace systems for medicines. These experts will be expected to aim to...
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...
