Interpretation Of Relevant Regulatory Documents And Response Strategies On China National Medical Device Quality Sampling And Inspection Work In 2022


In recent years, with the national policy and the continuous adjustment and optimization of the industrial structure around the country, the medical device industry, as high technology, high growth, high value-added industry, and both low pollution, low energy consumption, low carbon emissions, fits perfectly with China’s current “carbon peak” and “carbon neutral” concept. The development concept of “carbon peak” and “carbon neutral” has been strongly supported by local governments. With the booming development of the medical device industry, the regulatory means in the field of medical devices around the world are becoming more and more complete, the scale of law enforcement is becoming more and more stringent, and the importance of regulatory compliance is increasingly prominent for all kinds of market players in the field of medical devices.

The territory of China engaged in the field of medical devices related to production and business activities must be subject to the supervision of drug supervision and management departments at all levels. The primary basis for the implementation of regulatory actions at all levels of government is the State Council’s “Regulations on Supervision and Administration of Medical Devices” and the regulations and documents issued by the NMPA and local governments at all levels. Various regulations and documents on the registration and filing of medical devices, research, and development, production, business sales, transport and use, adverse events, recall system, etc., have made detailed provisions and for all types of products supporting the relevant technical standards to achieve the supervision of the whole life cycle of the product. At all levels of various types of regulatory instruments, the quality of medical device products sampling inspection, especially by the NMPA unified deployment, the provinces (including autonomous regions, municipalities directly under the Central Government, the Corps, the same below) level drug regulatory departments directly implement the national medical device quality sampling inspection work (hereinafter referred to as “national sampling”), is the highest level of administrative supervision means from government directly to the enterprise with the most importance.

On February 21, 2002, the national NMPA issued the “2022 National Medical Device Sampling and Inspection Program”, which formally deployed the “National Sampling” work to all provincial NMPA departments. In the following, we will explain the basic concepts, organizational procedures, working methods, and general rules of “national sampling” to our customers and combine them with our long-standing service to our customers. We will also propose corresponding response strategies for reference, taking into account our long experience in serving customers to deal with “national sampling.”

BradyKnows QA team has helped many overseas manufacturers for China NMPA audit and other QMS/PMS activities. We provide more detailed interpretations from below aspects. 

I. What is “national sampling” (basic concept)

II “National Sampling” is how to organize and implement (implementation procedures)

III The “national sampling” what to check (the main content)

IV How to be sampled (response strategy)

V. What will happen if you are not sampled (other cases)

VI. Notes

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