Aug 5, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has announced a public consultation on proposed amendments to the regulatory framework for medical devices that are substances introduced into the...
Read More
Aug 4, 2021
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to significant changes to medical devices already placed on the market. The document is intended to assist medical...
Read More
Jul 15, 2021
Canada
In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this year with Canadian medical device regulations. The two most significant changes discussed were new requirements related to foreign risk...
Read More
May 27, 2021
Europe
The Swiss Federal Office of Public Health, a division of the Federal Department of Home Affairs, has published an explanatory notice describing upcoming changes to the medical devices regulations. Regulatory Background The document provides additional clarifications...
Read More
May 20, 2020
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Food and Drug Authority (EFDA), Ethiopia’s national authority responsible for medical device regulation, has provided draft guidance regarding proposed changes to the rules and regulations on post-approval changes of medical devices.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...
Read More