Many places are continuing to strengthen the supervision of medical device products, and machinery companies will face major challenges

In recent years, with the continuous development of the medical device industry, the state has begun to tighten its supervision
.
In this context, random inspections and unannounced inspections have become routine, and information disclosure has gradually become the norm
.
It is reported that there have been many announcements of unannounced medical device inspections recently
.
On September 16, the Sichuan Provincial Drug Administration issued a notice, announcing the unannounced inspections of Class II medical devices in 2021, and a total of 45 general defects were found
.
The notice pointed out that for the 45 general defects found in the inspection, the Sichuan Provincial Drug Administration has ordered relevant companies to rectify within a time limit, and required companies to implement the main responsibility for quality and safety, analyze and find reasons, evaluate safety risks, and for those that may cause safety hazards, Recall related products in accordance with the "Medical Device Recall Management Measures"
.
In addition, the Anhui Provincial Food and Drug Administration has also continued to promote the quality and safety supervision of medical devices for epidemic prevention and control in the province in the near future, and organized supervisors to carry out centralized unannounced inspections of 11 medical device manufacturers
.
It is reported that during this unannounced inspection, two companies were ordered to suspend production for rectification
.
Industry analysts believe that with the implementation of the Regulations on the Supervision and Administration of Medical Devices, the compliance of medical device manufacturers will usher in an era of strong supervision
.
In order to respond to national policy documents, the supervision of the medical device industry will be stricter and more frequent
.
In fact, Wuhan has recently been continuously increasing the professional training of medical device supervisors, focusing on the supervision of medical aesthetics and medical devices and the investigation and handling of cases of violations of laws and regulations
.
Specifically, on September 15th, the Market Supervision Bureau organized Wuhan medical device supervisors to participate in the medical device supervision business training that can be used for medical cosmetology organized by the State Food and Drug Administration
.
On the 17th, relevant supervisors from various districts were also organized to participate in a video conference on the investigation and handling of illegal cases of medical beauty and medical equipment in the province
.
In the face of strict supervision, how should medical device companies respond to unannounced inspections? Industry insiders suggest that companies need to strictly control the purchase of raw materials, select good suppliers, ensure product quality from the source, and prevent the risk of product quality problems; strictly implement and supervise product release and control procedures
.
Check whether the product manual is consistent with the application scope description, use accessories, and operating instructions of the filed manual
.
In short, relevant companies must first achieve compliance development
.
It is worth noting that on September 18, the Comprehensive Department of the State Food and Drug Administration issued a notice on the “Work Plan for Strengthening the Quality Supervision of Selected Medical Devices in Centralized Mass Procurement”, which clearly stated that the provincial drug regulatory authorities should immediately organize the The selected enterprises in the national centralized procurement of artificial joints carry out special inspections and special random inspections on the selected varieties, and the special inspections and random inspections need to be reported to the Device Supervision Department of the State Food and Drug Administration before the end of 2021
.
In this context, the industry expects that relevant machinery companies will usher in more aspects of supervision and more challenges, and they need to be prepared in advance
.