Post Market Surveillance (PMS) & Quality Management System (QMS)
Since NMPA issued Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation on August 31st, more control, strictness, and timely post-market surveillance have been enforced in China.
With strong expertise in both post-market surveillance (PMS) and Quality Management System (QMS) requirements, China Med Device team can help you handle all the PMS issues long after your device is on the market, including Period Risk Evaluation Report (PRER), Adverse Event (AE)/Serious Adverse Event (SAE), recall, inspection, reporting, etc. We can also provide QMS establishment service by evaluating key QMS documents, conducting QMS assessment, design, and implementation, etc.
Period Risk Evaluation Report (PRER)
On May 6, National Center for ADR Monitoring issued a notice “Issues on Implementation of Periodic Risk Assessment Reports for Medical Device Adverse Events”. This notice provides a detailed explanation about the submission deadline and time range of data collection for the Periodic Risk Evaluation Report (PRER). Based on the information in the notice, the submission deadline of PRER for all class II and class III medical devices that are in the first registration cycle is Sep 30, 2020.
Who & When?
- Class II & III medical device with active certificate (in first registration cycle)
- Both 2019 & 2020 report should be submitted by September 30 (2019 was the first year of implementation of Order No.1)
- PRER should be submitted annually, the data collection start date should be consistent with the certificate approved date
- Class I medical device: 1) No need to submit PRER, just keep the record; 2) Write PRER in first 5 years, no reports required after that
To comply with these new requirements, you will need solid QA experience in understanding and interpretation of China AEs and related requirements. To save your time, China Med Device can help you prepare, write, and submit the periodic risk evaluation report. Here is the high-level checklist that we prepare for our clients.
Overseas Inspection
Overseas inspection is the global common way for medical device inspection and one of the important steps for Chinese medical device inspection to be internationalized. The Regulations have essential effects for supervising overseas enterprises to comply with Chinese regulations.
NMPA is responsible for medical device overseas inspection. NMPA makes inspection tasks through risk evaluation and random selection in accordance with the suggestions of draft inspecting medical devices, R&D site and manufacturing site from relevant departments.
China Med Device can provide you with the complete overseas inspection support: preparation prior to the inspection, onsite support during the inspection and post-inspection followup. We can certainly help you with the training on NMPA inspections to prepare your staff and perform a mock inspection per your needs.
Quality Assurance
China NMPA requires manufacturers to establish a qualified quality management system to maintain approval in China. China Med Devices QA team has 10+ years of experience with quality management system establishment and implementation to meet the specific requirements from China NMPA. We can help you with:
- Provide updates on product-related GMP regulations, guidelines, standards, etc.
- QMS assessment, design and implementation
- Key QMS documents evaluation
- Develop SOP on AE handling and recall process as per NMPA regulation
Adverse Event/Recall
In China, medical device adverse events (AE) refer to various harmful events that have occurred in the normal use of approved medical devices that have caused or may cause human injury. China Med Device can be your China legal agent and help you collect adverse event data and report to NMPA, cooperate with NMPA to investigate, analyze and evaluate the AE.
China Med Device’s seasoned post market surveillance professionals can also help you handling your whole recall process in China, including coordinating communication during a recall, reporting to NMPA according to your decision and comments, etc.
QMS/PMS Q&A
For your information, we have also prepared a list of commonly asked questions and our answers in the medical device/IVD/CDx QMS and PMS area. Please check below.
