Meeting with National Medical Products Administration on the Administration of Medical Device Adverse Event Monitoring
2019-04-18 | Beijing
On 18th 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.