Meeting with National Medical Products Administration on the Administration of Medical Device Adverse Event Monitoring

2019-04-18 | Beijing

On 18^th April, the National Medical Products Administration (NMPA), along with National and Provincial Centers for Adverse Drug Reaction (ADR) Monitoring, held a meeting regarding the administration of Measures on Medical Device Adverse Event Monitoring, and the Guideline for Monitoring Adverse Events in particular.

The European Chamber presented a few key points during the meeting on the Guideline for Monitoring Adverse Events and the Implementation of the Periodic Safety Update Report. The presentation was recognized by NMPA:

Per the Guideline for monitoring adverse events

-  All relevant parties must report the events of death and serious injury

-  Market Authorization Holders must submit the evaluation of the events of death and serious injury

-  The reports submitted by medical institutions must fits the four elements of a qualified reports

Per the Implementation of the Periodic Safety Update Report:

-  It should apply to the products registered after 1st January

-  The authority should be delegated to the enterprise to deal with or even close down other suspicious adverse events

The presentation was recognized.