post-market surveillance means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
post-market surveillance means all activities carried out by the manufacturers and other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market, made available282 or put into service for the purpose of identifying any need to immediately apply any necessary corrections, corrective or preventive actions.283
post-market surveillance means procedures taken by a Party after a product has been placed on its market to enable the Party to monitor or address compliance with the Party’s domestic requirements for products.
More Definitions of post-market surveillance
post-market surveillance means the practice of monitoring the safety and quality of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance;
post-market surveillance means a program in place after the receipt of Regulatory Approval to be further defined in a pharmacovigilance agreement pursuant to Section 7.2 that provides for monitoring the safety of a product in the market, including reporting of certain Adverse Events to Regulatory Authorities; monitoring, investigating, reporting, and responding to complaints from the market, whether medical, technical, or otherwise; and evaluating whether additional actions, such as a label amendment, dear doctor letter, or recall, may be necessary.
post-market surveillance means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of
post-market surveillance means a program in place after the receipt of Regulatory Approval to be further defined in a pharmacovigilance agreement entered into pursuant to Section 8.2 that provides for (a) monitoring the safety of a product in the market, including reporting of certain Adverse Events to Regulatory Authorities; (b) monitoring, investigating, reporting, and responding to complaints from the market, whether medical, technical, or otherwise; and (c) evaluating whether additional actions, such as a label amendment, dear doctor letter, or recall, may be necessary. 1.94 “Primary Position Detail” means, with respect to the Product, a Detail (a) in which key attributes of the Product are orally presented consistent with the terms of this Agreement and
post-market surveillance means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place
post-market surveillance means a program in place after the receipt of Regulatory Approval to be further defined in a pharmacovigilance agreement entered into pursuant to Section 8.2 that provides for (a) monitoring the safety of a product in the market, including reporting of certain Adverse Events to Regulatory Authorities; (b) monitoring, investigating, reporting, and responding to complaints from the market, whether medical, technical, or otherwise; and (c) evaluating whether additional actions, such as a label amendment, dear doctor letter, or recall, may be necessary.
post-market surveillance means the practice of monitoring the safety and quality of a pharmaceutical drug or medical device after it has