NMPA published the notice Enhance Quality Inspection for Sterile and Implantable Medical Devices on April 14, 2020.
Regulations to be Based upon
- Regulations for the Supervision and Management of Medical Devices
- Measures for the Supervision and Management of Medical Device Production
- Measures for the Supervision and Management of Medical Device Supply
- Measures for the Supervision and Management of the Quality Inspection of Medical Device
- Administrative Measures on Medical Device Sampling Inspection
- Administrative Measures on Monitoring and Re-evaluation of Adverse Events of Medical Devices
- Medical Device Instructions and Label Management Regulations
- Guidance on Medical Device Cold Chain (Transportation) Management
For an English documents mentioned above, please email info@ChinaMedDevice.com.
Key Categories of Devices
Comprehensive inspection for sterile and implantable devices, with a focus on high-value consumables, Covid-19 personal protective equipment (PPE), such as gowns and face masks, and disposable infusion devices.
Key Manufacturers to be Inspected
- Manufacturers with flawed devices in the past sample inspection
- Manufacturers with flawed Quality Management System (QMS) in the past inspection
- Manufacturers with inadequate self-inspection report
- Manufacturers with potential safety risks
NMPA are to check the following:
- Whether the clean room control meets requirements
- Whether the production equipment and inspection equipment match the requirements of product(s) and scale of production
- Whether the modification registration is implemented after product change, especially the related standards are updated
- Whether procurement procedures are compliant with requirements and suppliers are audited
- Whether the special manufacturing methods are identified and effectively controlled
- Whether the sterilization process control meets the requirements
- Whether the quality control and product release meet the standards and product technical requirement (PTR)
- Whether the adverse event collection method is established
NMPA asks manufacturers to pay extra attention to:
- Disposable infusion equipment if the identification of fluorescent substances in PVC infusion and transfusion equipment and quantitative supplementary inspection method meet the requirements, and if the raw materials are controlled
- Residual amount of ethylene oxide if it meets the standard, and if verification and validation are recorded
The document also mentions the inspection procedures of supply chain and usage of medical device.
China Med Device has extensive experience for establishing QMS system and conducting mock inspection. Email info@ChinaMedDevice.com to learn more.
For our webinar on NMPA Latest Regulatory Updates with PMS & QMS Focus, please click HERE.