For the evaluation of health supply registrations, Mexico’s Federal Commission for Protection of Sanitary Risks (COFEPRIS) released a new agreement for the equivalency requirements established in articles 167, 170, 177, 177 Bis 2, 179 and 180 of the Health Supplies Regulations and the technical evaluation procedures performed by COFEPRIS. In these cases, the COFEPRIS review is abbreviated.
Equivalency agreement general provisions
This agreement determines the conditions that COFEPRIS must observe to recognize the decisions of other reference regulatory authorities (RRA) and the World Health Organization's Drug Prequalification Program regarding health supplies, including medical devices.
COFEPRIS’s regulatory decisions will be based on risk management, as well as on the decisions and evaluations made by the RRA (and the WHO Medicines Prequalification Program) to confirm the quality, safety and efficacy of medical devices.
Mexican Regulator COFEPRIS Revises Equivalency Route to Expand Leveraging Options | Emergo by UL
Mexican Regulator COFEPRIS Revises Equivalency Route to Expand Leveraging Options
To evaluate health supply registrations, Mexico’s COFEPRIS released a new agreement for the equivalency requirements established by the Health Supplies Regulations.
www.emergobyul.com