The NMPA published Checkpoints for Medical Device Registrants and Fillers Conducting Adverse Event Monitoring on April 9, directing the manufacturers for quality management system inspection and adverse event monitoring.
Key Takeaways for Manufactures
The document specifies the checkpoints from four major aspects:
- Institutions and personnel
- File management
- Design development
- Analysis and measures for adverse events monitoring
In the section of analysis and measures for adverse events monitoring, NMPA asks manufactures to pay attention to 13 fields, including but not limiting to the following:
- Check if conditional approval requirements are listed in the approval certificate. If there are, check the relevant documents for risk management and control.
- Check the patient number from medical institutions’ report. If there is a gap between that of manufacture’s, an explanation must be given by the manufacturer.
- Check the Periodic Risk Evaluation Report after the product goes on the market. The content of the report should at least include: summary and analysis of the adverse event reports, monitoring data, domestic and overseas risk information, and risk control measures taken.
A Periodic Risk Evaluation Report is required to submit to NMPA, according to Decree 1 Measures on Adverse Event Reporting and Reevaluation. It is the obligation of each applicant to fulfill the requirement and submit this report at certain time point. We have formulated the template of Periodic Risk Evaluation Report. Email info@ChinaMedDevice.com to get a copy.
- Check if there are supplemental reports when the follow-up inspection occurred.
- If the device involves key monitoring variety, check if the applicants are working in accordance with the requirements of the key monitoring plan, and check the relevant documents and records.
Monitoring of Innovation Device
For innovation devices’ monitoring plan, NMPA will check the following to enable the applicants meet the post-market requirements:
- If the applicants collect adverse event reports and product complaints from major users of the product.
- If the applicants investigate, analyze, and evaluate the adverse event reports and product complaint information.
- If the applicants submit the monitoring, analysis, and evaluation summary report in a timely manner.
Legal Representative’s Role
Legal representative has played a far more significant role than ever before, as Decree 1 requires all the adverse events information be provided to your legal representative to compile and report to China regulatory authority. It is important to collect the information and make them available to your legal representative because NMPA increasingly relies on post-market surveillance to achieve full regulatory compliance.
China Med Device, LLC is an NMPA certified legal representative. We can help you fulfill the pre and post market legal agent requirements without your need to setup office in China. For more details on legal representative related regulations, email us at info@ChinaMedDevice.com.
Mentioning about legal representative the document reiterates the articles in the Decree 1 as bellow:
- Overseas applicants shall establish an information transmission mechanism with their legal representatives in a timely manner.
- For adverse event that may cause serious injury or death, the domestic or overseas applicants and their legal representatives shall report it within 30 days from the date of discovery or knowledge.
- If an imported medical device has a medical device adverse event abroad, or a domestic medical device has a medical device adverse event abroad, and control measures are taken, the domestic or overseas applicants and their legal representatives shall report it within 24 hours after being notified.