Medical device unannounced inspections are unannounced supervisory inspections carried out by NMPA around safety risk prevention and control, and are characterized by surprise, independence, and efficiency. Continuously conducting unannounced inspections of medical device manufacturers and announcing the problems found during inspections and their corresponding handling measures will not only form a strong deterrent to enterprises and strengthen their awareness of conscious implementation of quality management systems, but also enhance inspectors’ ability to detect problems and handle problems in accordance with laws and regulations.
The Medical Device Supervision and Administration Department of the National Medical Products Administration formulates annual unannounced inspection plans for medical device manufacturers based on regulatory priorities, and the Center for Food and Drug Inspection of NMPA is responsible for the implementation of inspection tasks.
Features of Unannounced Inspection
Feature 1: Secrecy of Actions
Arrangements for unannounced inspections are relatively secretive even within the organization and implementation departments. Only leaders and responsible persons in charge of the work have the information. The drug regulatory department where the company is located was notified only within the deadline, and it was even less likely that the company would be notified.
Feature 2: The Suddenness of the Inspection
Due to the secrecy of unannounced inspections, it is impossible for the inspected company to make any preparations in advance. What the inspection team sees on site is the true status of the company’s daily production management.
Feature 3: Insulation of Reception
The unannounced inspection team must pay expenses of food, hotels, and cars by itself. All expenses shall be paid by the Drug Certification and Management Center.
Feature 4: On-site Flexibility
The specific time and steps of the inspection team’s on-site inspection will be determined by the inspection team based on inspection needs to ensure the quality of the inspection.
Feature 5: Immediacy of Recording
The inspector must fill in the unannounced inspection work record immediately during the on-site inspection. When entering each work site, you must fill in inspection content, contact persons, situation records, etc. according to the specific circumstances.
Situations That May Trigger Unannounced Inspections
(1) Complaints and reports or clues from other sources indicate that there may be quality and safety risks;
(2) Inspection reveals that there are quality and safety risks;
(3) Adverse drug reactions or monitoring of medical device adverse events indicates possible quality and safety risks;
(4) There is any doubt about the authenticity of the application materials;
(5) Suspected of serious violation of quality management regulations;
(6) The enterprise has a record of serious breach of trust;
(7) Other situations that require unannounced inspections.
With the continuous improvement of regulatory needs, unannounced inspections at this stage mainly include compliance inspections, cause-based inspections initiated by risk signals such as complaints, inspections, and adverse reaction monitoring, as well as special inspections of certain types of products.
As the number of companies undergoing unannounced inspections increases year by year, the scope of inspections also continues to expand. Unannounced inspections in 2015 only involved sterile and implantable products, and these two types of high-risk products continued to maintain a high proportion of inspections, accounting for more than 60% of the total number of inspections throughout the year. Starting from 2016, unannounced inspections have covered active and in vitro diagnostic reagent products. On December 21, 2016, the “Medical Device Manufacturing Quality Management Practice Appendix Customized Dentures” was released. In order to conduct an on-site investigation of the company’s implementation, unannounced inspections of customized denture products were launched in 2018. For more detailed information on unannounced inspection varieties over the years, please contact us by email or phone.
Regarding the inspection results, according to the assessment principles of unannounced inspection of medical device manufacturers, if the on-site inspection finds that the enterprise has serious defects, or if the non-conforming items may have a direct impact on product quality, the enterprise must stop production and make rectifications. If there are only general items that do not meet the requirements and do not have a direct impact on product quality, the enterprise must rectify within a time limit.
In March 2022, the NMPA issued the “Notice on the Release of Guidelines for the Preparation of Annual Self-Inspection Reports on the Quality Management System of Medical Devices” (No. 13, 2022), which stipulates the annual self-inspection reports on the quality management system of manufacturing enterprises. This shows the importance of self-examination of the quality system. This is not only an external form of self-examination, but also an internal inspection on a daily basis. It is important to discover problems in a timely manner and make improvements without perfunctory or avoiding any problems. Only by taking responsibility for yourself can you cope with external inspections at any time and under any circumstances.
