China NMPA’s observations of ‘flight inspection’ on medical devices

In 2023, the China NMPA(National Medical Products Administration) conducted ‘flight inspections’ (unannounced inspections) to 20 medical device manufacturers. A total of 176 observations were raised in the following 11 areas according to the structure of the chapters of China GMP on medical devices.

Among the above 176 observations, only two observations are critical, and the others are all minor ones. The company that received the two critical observations immediately ceased production, and as of the time the report was published, they also were ceasing production and taking corrective action. All the other companies have completed corrective actions

Considering the content of the observations raised, observations on manufacturing management (29) are the most, and this is followed by observations on equipment (26), facility and buildings (25), document management (21), quality management (20) and design development (20).

Among the observations on manufacturing control, the most common ones are related to production records. Article 50 of Medical Device GMP states that ‘Production records should be created for each lot (or device), and they should traceable. The production record includes the product name, specifications and model, lot number of raw material, production lot number, or product number, production date, quantity, main equipment, process parameters, operators, etc."  It is often raised that required records were not kept or that production records are incomplete, for example operation time and temperature were not recorded. The second common observation is inadequate labeling to prevent mixing and wrong use.

Regarding equipment, the most common observation is that the instruments were not calibrated, or the calibration validity period had expired. The second common observation is the indication of equipment status, which violates the requirement of Article 20 ‘The status of production equipment should be clearly indicated so as to prevent unintended use.’ Another problem is that there was no logbook of equipment use or that the records were incomplete. This violates Article 22 of the Medical Device GMP which states that ‘Manufactures should maintain records of the use of testing and examine equipment, including their use, calibration, maintenance, and repair.''

Regarding facility and buildings, the most common observation is that temperature and humidity control in warehouses for storing raw materials/ semi-finished products/products did not meet specified requirements, and that area for storing rejected and accepted products were not separated and indicated to prevent mix-up. In addition, it was often observed that the pressure differential between the manufacturing area and corridors is not maintained.

Regarding document management, the most common observation is that updates and revisions to procedures and other documents were not reviewed and approved. This violated the requirements of Article 25(2) of Medical Device GMP.

Regarding quality management, the most common observation relates to retention sample management. It has been observed that the procedure does not specify the storage amount or that the sample is not stored according to the procedure. In addition, it has been pointed out that manufacturing and testing were not carried out in accordance with procedures.