FDA The new article highlights specific aspects related to the entrance review, the ones the authority will also assess when determining the eligibility of the product and application associated thereto for review under the appropriate framework. ...
Africa The new article describes in detail the responsibilities of the parties involved in operations with medical devices in terms of post-marketing surveillance. Table of Contents The Ministry of Health of Kenya has published a guidance...
FDA The article provides an overview of the regulatory requirements for medical devices used to improve glycemic control. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties...
Asia The new article describes in detail the approach to be applied by a party responsible for a medical device when notifying the regulating authority about the changes to the product already placed on the market. Table of Contents The Health...
FDA The new article addresses the aspects related to the factors for Safer Technologies Program (STeP) entrance and review process. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Ethiopia The article provides an overview of the regulatory requirements for medical device labeling introduced in Ethiopia. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare...
