Health Canada Continues to Actively Monitor Supply of Medical Devices

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.

QCC x GMP: How does the Quality Control Certificate relate to ANVISA’s Good Manufacturing Practices?

QCC x GMP: How does the Quality Control Certificate relate to ANVISA's Good Manufacturing Practices?

The QCC (Quality Control Certificate) is indeed associated with ANVISA’s Good Manufacturing Practices (GMP), but they are not exactly the same thing. ANVISA’s GMP (Good Manufacturing Practices) is a regulatory requirement that certifies that health product companies, such as medicines and medical devices, follow safe and effective manufacturing practices. QCC certification is a type of quality control documentation that can be used to certify compliance with ANVISA’s GMP standards, but QCC itself is more of a type of control certification and does not replace the formal GMP authorization issued by ANVISA

ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force

ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force

The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.

The U.S FDA Announces Pilot Program for Medical Device Submission with Health Canada

Overview On January 2023, the FDA announced that it has partnered with Health Canada to launch a joint eSTAR pilot. The pilot will allow medical device manufacturers to submit a premarket notice submission to FDA and Health Canada simultaneously. Introduction The eSTAR is an interactive PDF form that helps guide applicants through the medical device […]