China’s National Medical Product Adminstration (NMPA) updates and address some common issues faced by the Marketing Authorization Holders to submit PRER report.
According to China’s Decree No. 1 Administrative Measurer of Medical Device Adverse Event Monitoring and Re-evaluation (effective since Jan 1, 2019), each Marketing Authorization Holder is obliged to fulfill the requirements of Periodic Risk Evaluation Report (PRER) and submit the report to the NMPA at a certain time.
Industry Questions answered by NMPA:
For Class I device, a regular risk evaluation report is written every year in the first five years.
If the product is cancelled in the fourth year, can it only be written until the fourth year?
If the product is still on market, it is recommended to write regular risk assessment reports
For products in the first registration cycle is written once a year, and the start date (month, day) of the data collection is consistent with the time when the approved registration documents are obtained.
If the product is registered in May 2016, does the supplement reports need to be for 2016-2017 and 2017-2018, or for 2019 and 2020?
Only report of 2019 and 2020 should be supplemented.
An imported product was first registered in 2015 and expired in 2020.
If the registration is not renewed, periodic risk evaluation report should be submitted?
If the product has been discontinued and no manufacturer can be found, how to write a regular risk assessment report?
For products that do not seek renewal, companies shall ask the original manufacturers write a regular risk assessment report; and those who cannot find original manufacturers, a description of the situation should be submitted.
The product has not been sold after obtaining the registration certificate (the previous national sampling also indicated that there is no sample).
Is it necessary to submit a periodic risk assessment report?
It should be written, with the information of foreign adverse event analysis, measures taken, and literature analysis. If any information is missing, a description of situation shall be submitted.
Regarding Article 3.2.2 of the regular risk evaluation drafting specification, the relevant requirements put forward when the product is approved for marketing, especially the requirements related to risk control.
Article 3.2.2 is the Design Failure Mode & Effects Analysis (DFMEA)?
Article 3.2.2 refers to the requirements related to risk control raised when the registration is approved, which may be related to DFEMA. However, this part is only summary information instead of analysis.
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