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): To comply with this new requirement for submitting the mandatory Periodic Risk Evaluation Report (PRER) before Sep 30 2020, 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. Overseas Inspection: 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 Med Devices QA team has 10+ years of experience with quality management system establishment and implementation to meet the specific requirements from China NMPA. Adverse Event/Recall: 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.