The Chinese government is enhancing efforts in post-market surveillance by investing heavily in both financial resources as well as implementing more comprehensive and stricter regulations. China Med Device QA team can help our clients to establish a compliant Quality Management System, provide incident solutions for adverse events, recalls, and overseas inspection.
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)
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.
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.
- Provide updates on product-related GMP regulations, guidelines, standards, etc.
- QMS assessment, design and implementation
- Key QMS documents evaluation
- Develop SOP on AE handling ane recall process as per NMPA regulation
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.