On April 14, 2020, China NMPA published a new notice to Enhance Quality Inspection for Sterile and Implantable Medical Devices it plans to perform random inspections to medical device manufacturers in China. The inspections will target manufacturers of consumable medical devices used for the prevention and control of COVID-19, such as personal protective equipment (PPE), face masks, and disposable infusion devices.
NMPA inspection goals:
The goal of these inspections is to check if medical device manufacturers comply with the following regulations:
- 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
Manufacturers Targeted by NPMA Random Inspections
NMPA will focus its inspections on the companies that:
- Manufacture multiple batches in the same year,
- Manufacture the same variety of product over many years,
- Showed serious QMS deficiencies during previous inspections,
- Failed to submit self-examination reports or didn’t submit the reports on time,
- Have serious risks and require special attention.
NMPA Self-examination Process
The NMPA is requesting manufacturers of sterile and implantable medical devices to submit to local provincial drug supervision and administration departments, self-examination reports before the end of June 2020.
The self-examination reports must be completed by the manufacturing department, signed by the responsible person and sealed before submission to the municipal and county-level department in charge of the supervision of the medical devices.
According to the Notice companies that fail to submit self-examination reports shall be strictly supervised, and shall be subject of severe penalties for violations of laws and regulations.
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GRP videos. Registration of Medical Devices in China.
GRP China. Medical Device Page.