Africa
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the rules prescribing the collection of samples to be...
Africa
The Tanzania Medicines & Medical Devices Authority (TMDA), the country’s regulating authority responsible for healthcare products, has published a draft regulation on good storage and distribution practices with regard to medicines and medical devices. Regulatory...
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Food and Drug Authority (EFDA), Ethiopia’s national authority responsible for medical device regulation, has provided draft guidance regarding proposed changes to the rules and regulations on post-approval changes of medical devices.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...
