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Three Imported Devices Found Defects in On-site Inspection


NMPA conducted on-site quality inspection on eleven types of medical devices and released the result on December 18, 2023. Eighteen manufacturers are found incompliance, including three overseas companies.

Companies Found Defects

  • Abbott Diagnostics: Treponema pallidum antibody detection kit

Root cause: the minimum detection limit and repeatability do not meet the standards.

  • GALLINI S.R.L.: Biopsy needles

Root cause: the dimensional tolerances do not meet standards.

  • Nidek Medical: Portable oxygen generator

Root cause: the outlet pressure does not meet the standard.

Manufacturers found defects are required to issues recalls. Supervised by provincial NMPA, they should adopt Corrective and Preventive Actions in time. Other devices include:

  • Disposable sputum suction tube
  • Sputum suction bag
  • Far infrared therapy patch
  • Disposable sterile surgical membrane
  • Radiation protection clothing
  • Medical radiation protective gloves
  • Ophthalmic laser treatment machine
  • Electromyographic biofeedback instrument
  • digital electrocardiograph
  • Homocysteine determination kit (cycling enzyme method)

Key Areas for NMPA Quality Inspection

The “Guideline on Inspection of Quality Management System for Medical Device Registration”, issued in October 2023, clarifies the key contents for the on-site inspection:

  • institutions and personnel
  • facilities and equipment
  • document management
  • design and development
  • procurement, production
  • quality control
  • commissioned production
  • authenticity

In the case that the production is commissioned, the guideline asks applicant specifies the department and personnel responsible for guiding and supervising the QMS of the entrusted enterprise, and in principle, a manager representative should be designated to be responsible for the quality management of the entrusted production.

Device Categories in Design Process

The guideline emphasizes QMS in the design process. It specifies the requirements for each device category:

Non-active medical devices

The raw material components of non-active medical devices shall meet the requirements of relevant standards, and the biocompatibility evaluation shall be completed for the parts in contact with the human body. When reusable sterile products are re-sterilized, the performance of the finished product should be evaluated, and a tolerability re-sterilization study should be completed.

Active medical devices

Active medical devices should complete relevant researches according to the standard requirements, such as electric shock hazard protection, mechanical hazard protection, radiation hazard protection, over-temperature hazard protection, electromagnetic compatibility, biocompatibility, etc.

Animal source medical devices

Animal-derived medical devices should complete research on animal species (if the risk is related to the strain, the strain needs to be specified), geographic origin (for species whose geographic origin cannot be determined, provide source animal survival period identification and traceability requirements), age (applicable when relevant to risk, e.g. susceptibility of animals to naturally occurring transmissible spongiform encephalopathy), type of sample site and tissue, animal and tissue health status, verification on virus inactivation method, etc.

IVD reagents

The main raw materials, intermediates, important excipients, etc. involved in the research process of in vitro diagnostic reagents shall have clear sources and meet the requirements, and the equipment, instruments and reagents used in the research process shall meet the research requirements.

To assess whether you are compliant with NMPA quality requirements, please email us at

Visit HERE for NMPA QMS Inspection Guideline

For inspection results on other overseas manufacturers, please click HERE

For 2023 inspection plan, please click HERE

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