China NMPA Released Plan For Annual Medical Device Quality Inspections
2024-02-28
As the annual China NMPA medical device quality inspections gear up from March to April, lasting until the end of May. BradyKnows, as a licensed agent, takes proactive steps to ensure compliance and quality assurance for our clients.
During the inspections, which typically fall into two categories:
1. On-Site Inspections at Company Warehouses: Regulatory officials will directly visit company warehouses for on-site inspections.
2. Market Inspections: The scope of inspections covers the sales of medical devices in markets, including from operating companies and medical institutions.
These inspections strictly adhere to the guidelines set forth in the Management Measures for Inspection and Testing of Medical Device Quality. The inspection plans outline specific requirements for products, testing items, and more.
Handling of Non-Compliant Products:
Products found to be non-compliant during inspections will have their results announced on the official website of the National Medical Products Administration. This announcement will include a list of products that do not meet standard requirements and specify the non-compliant aspects.
Simultaneously, regulatory authorities will urge the local NMPA where the manufacturing companies are located to take administrative measures in accordance with the Regulations on the Supervision and Management of Medical Devices, Measures for the Supervision and Administration of Medical Device Production, and Measures for the Recall of Medical Devices, among other regulations. They will also make these decisions public.
Risk Assessment and Recall Measures:
For products found to be non-compliant during inspections, a risk assessment will be conducted to determine the recall level based on the severity of the medical device defects.
Relevant companies will be urged to proactively recall non-compliant products and make the recall information public.
Additionally, regulatory authorities will press companies to promptly identify the reasons for product non-compliance, develop corrective measures, and ensure timely and thorough implementation.
These measures aim to strengthen the supervision of medical device quality to safeguard public health and safety. The National Medical Products Administration calls upon companies to strictly comply with relevant regulations, ensuring that the produced medical devices meet standards and provide safe and effective medical care for patients.
As a licensed agent, BradyKnows is committed to upholding the highest standards of quality and compliance in the medical device industry, and BradyKnows’ active co-operation and proactive approach to customer due diligence not only demonstrates BradyKnows’ commitment to regulatory compliance, but also emphasises its responsibility to public health and safety. By staying ahead of the curve and quickly resolving any potential issues, BradyKnows will continue to be a trusted and reliable partner in the field of medical device management and oversight.
