Health Canada Continues to Actively Monitor Supply of Medical Devices
Health Canada’s role in managing medical device shortages in Canada. It explains how the government continuously tracks and updates the list of devices in short supply, ensuring transparency and quick responses to potential shortages. By working closely with manufacturers, importers, and healthcare providers, Health Canada aims to stabilize the supply chain through regulatory adjustments and proactive policies.
ANVISA Publishes RDC 936/2024: New Guidelines for Health Products and Their Implications for Medicine
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution (RDC) 936/2024, which establishes new guidelines for the regulation of health products. These changes aim to improve the safety and efficacy of products used in medicine, directly impacting health professionals and patients.
ANVISA Publishes Database for Clinical Investigations into Medical Devices
The National Health Surveillance Agency (ANVISA) has announced the launch of a database aimed at clinical investigations related to medical devices. This initiative represents an important milestone in the health sector, promoting greater transparency, efficiency and safety in research carried out in Brazil.
Brazil’s ANVISA Announces Medical Device Registration 2022 Updates
ANVISA Brazil announced in early September 2022 important updates to its Collegiate Directorate Resolution (RDC) 185/2001.
The changes strengthen the country’s medical device registration regulations on the effective date of March 1, 2023.
NMPA releases a final guidance on Device Master File (DMF) submissions
As per the Announcement no. 36 of 2021, lists requirements for voluntary submission of domestic Class III and imported Class II and III medical devices and IVDs.
Anvisa will begin monitoring prices of medical devices
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
Brazil’s Anvisa publishes guide about cyber security in medical devices
Anvisa publishes Guide 38/2020, “Principles and Practices of Cyber Security in Medical Devices”. The document is intended for anyone interested in ensuring the safe use of medical devices and will be useful for users of such equipment, patients, manufacturers, distributors, health services and researchers in the area of safety
Brazil’s Anvisa Announces New Medical Device Regulations
On September 18,2020 Brazil’s Anvisa published the RDC no. 423/2020 which deals with the extinction of the registration and migration of medical devices of risk class II to the notification regime.
United Kingdom’s MHRA releases a list of exempted medical devices
United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) developed a list of medical devices which can be marketed without CE marking.
Colombia’s Invima modifies administration measures due to COVID-19 pandemic
Invima changes the transitional administrative measures under Resolution 2020012926 of 3rd April 2020 due to COVID-19
Singapore’s HSA Announces Guidance on 3-D Printing on Essential Medical Device for COVID-19
The Health Science Authority (HSA) released a guidance in response to the COVID-19 demand for medical devices like nasopharyngeal swabs, personal protective equipment, face shields and respiratory accessories.
EMA FAST TRACKS FOR MEDICINES AND VACCINES DURING COVID-19 PANDEMIC
On May 4, 2020, The European Medicines Agency (EMA) details the rapid approval procedures for COVID-19 products which includes scientific advice, rolling reviews, accelerated assessments.