Adverse Event Reporting
Adverse event reporting obligations and timeframes for medical device registrants in China.
8 docs tagged with "post-market"
View all tagsAnnual Reports
Annual self-assessment report obligations for medical device registrants under NMPA.
Distribution and Traceability
Distributor record-keeping, implant traceability, and hospital obligations in China.
Labelling Requirements
Mandatory labelling elements, IFU requirements, and language obligations for medical devices in China.
Post-Market Overview
Overview of post-market obligations for medical device registrants under MDSAR 2021.
Post-Market Surveillance
PMS plan requirements, complaint handling, and ongoing monitoring obligations in China.
Re-Registration (éæ°æłšć)
5-year certificate renewal process for medical devices in China.
Recalls and Field Safety Corrective Actions
Recall obligations and FSCA procedures under NMPA and MDSAR 2021.