Post Market Surveillance
Medical device post market compliance include annual report(AR), product recall, adverse events (AE) and periodical re-evaluation of the risks (PRER).
Medical Device Annual Report (AR)
According to NMPA Order 13–2022, the overseas MAH shall submit the Annual report by the March 31 via its in-country representation. The template and items to be reported are addressed in relative regulatory documents. GVMMedicalTM RA team will help you to keep compliance to China regulatory requirements.
Medical Device Recall
Every country has its own regulatory requirements regarding product recall, such as the report scope, classification, timing and management database, etc. When necessary, GVMMedicalTM will help you to analysis the issue and handle it properly so as to keep you compliance to China Medical Device regulatory requirements.
Adverse Events Reporting (AE)
Adverse events are highly concerned by regulators of all countries. GVMMedicalTM will help to build up the adverse events reporting SOP and handle the adverse events reporting in the NMPA Platform. You don’t need to worry about the compliance issue about adverse events.
Periodic Re-Evaluation of the Risks (PRER)
Periodical re-evaluation of the risks of the product is required for every product. Some of the PRER reports are required to submit to NMPA. GVMMedicalTM RA team will help you to keep compliance with the China medical device regulatory requirements.
QUESTIONS?
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GVM MedTech RA/QA Service
Why Choose US
Good Knowledge
We dedicate to study the regulation update context that we provide you the accurate insight of the regulations.
Bilingual & Cross-Cultural Experts
Our project manager (PM), business development rep (BD), and part of the experts have background working in US and China.
A network of industry experts
The diversity of the medical device industry makes expert networks extremely important
Hard Working
We respect your time and money, our U.S. and Chinese teams worked together to create a 7/24 rhythm. We will try our best to keep your project proceed in a timely manner.