New E-filing Catalogue For Medical Device Registration Effective Since Jan 1, 2022
According to the Regulations on Supervision and Administration of Medical devices (Order 739), the Administrative Measures for Registration and Filing of Medical Devices (Order 47) and the Administrative Measures for Registration and Filing of IVD (Order 48), new e-filing catalogue (eRPS) will be effective since Jan 1, 2022.
More dossiers will be required for registration submission through NMPA e-filing system since Jan 1, 2022. The below table lists the major amendments on current eRPS catalogue.
|
eRPS Chapter |
NMPA Requirement |
|
|
Since 1/1/2022 |
Before 1/1/2022 |
|
| CH2.6.1 Global marketing status |
R |
CR |
| CH2.6.2 Global AEs and recalls |
R |
CR |
| CH2.6.3 Global sales, AE status and recall rate |
R |
CR |
| CH3.6 Non-clinical research literatures |
R |
NR |
| CH3.7.2 Packaging validation |
R |
CR |
| CH6A.4 QMS procedure |
R |
NR |
| CH6A.5 Management accountability procedures |
R |
NR |
| CH6A.6 Resource management procedures |
R |
NR |
| CH6A.7 Product realization procedure |
CR |
NR |
| CH6A.7.1 Design and development procedures |
R |
NR |
| CH6A.7.2 Procurement procedures |
R |
NR |
| CH6A.7.3 Production and service control procedures |
R |
NR |
| CH6A.7.4 Monitoring and measuring device control program |
R |
NR |
| CH6A.8 Measurement, analysis and improvement procedures |
R |
NR |
| CH6B.2 Quality Management System Information |
R |
NR |
To understand more requirements for China medical device and IVD registration, please attend our upcoming webinar: Revisiting Order 739 – Significant Updates for Medical Device Registration in China: Dossier Prep, Self-Testing, CER, and PMS. Or email us: info@inspirativemed.com
Registration Link:
https://zoom.us/webinar/register/WN_q7DBXq8zTTGppf7vyyWoXQ
