The era of strong medical equipment supervision has come, and medical equipment personnel will face the normalization of unannounced inspections

 The good side of the product is presented to the public, while the bad (unqualified) side is exposed to the public one by one
.
With the increasingly strict supervision of medical devices, medical equipment personnel will face the normalization of random inspections, routine inspections, and normalization of information disclosure
.
It is reported that recently, many places have announced the situation of unannounced medical equipment inspections
.
On September 16, the Sichuan Provincial Drug Administration issued a notice, announcing the unannounced inspections of Type II medical devices in 2021, that is, unannounced inspections of 6 Type II medical device manufacturers, 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"
.
After the rectification of the enterprise is completed, the product risk assessment report and rectification report shall be submitted to the First Inspection Branch of the Sichuan Provincial Drug Administration, which shall be archived for future reference
.
In addition to Sichuan Province, the website of the Guangdong Provincial Food and Drug Administration has also been screened by the unannounced inspection notice recently
.
It is reported that since August 17th, medical device companies have ceased production activities
.
For example, 12 medical device companies such as Shenzhen Weituoli Medical Electronics Co.
, Ltd.
, Guangdong Zhike Electronics Co.
, Ltd.
, Foshan Trinon Protective Products Co.
, Ltd.
, and Dongguan Xiehe Medical Device Technology Co.
, Ltd.
have serious quality management systems.
Defects, non-compliance with the relevant provisions of the medical device production quality management regulations, stop production activities, report to the provincial and municipal drug regulatory authorities, and carry out rectification and implementation of the problems found, evaluate product safety risks, and if they are likely to cause safety hazards, follow The "Administrative Measures on Medical Device Recall" stipulates that related products should be recalled
.
For another example, the Anhui Provincial Food and Drug Administration has also recently continued to promote the quality and safety supervision of medical devices for epidemic prevention and control in the province, and organized supervisors to carry out centralized unannounced inspections of 11 medical device manufacturers.

.
This centralized unannounced inspection adheres to the problem-oriented approach, focusing on enterprises that are unqualified in the supervision of random inspections, failing to submit self-inspection reports or self-inspection zero defects, intermittent production, etc.
, and whether the quality management system of the enterprise is effectively maintained and whether key positions are frequently changed.
, Check whether unqualified products are timely controlled and analyzed and improved, whether post-marketing changes meet regulatory requirements, whether batch production records are true, complete and traceable, etc.
, as the key content, in-depth investigation of hidden dangers of corporate quality and safety risks, and strict investigation of violations of laws and regulations, Supervise and urge enterprises to fully implement the main responsibility for product quality and safety
.
During this unannounced inspection, the two companies were ordered to suspend production for rectification
.
It is understood that with the implementation of the "Regulations on the Supervision and Administration of Medical Devices", the compliance of medical device manufacturers has ushered in an era of strong supervision
.
The regulations clarify the medical device approval and filing procedures, enrich the supervision methods, add supervision measures such as product unique identification traceability, extended inspection, increase the punishment of illegal acts, and significantly increase the fines for serious violations involving quality and safety, up to 30 times the fine , Severe penalties such as revocation of licenses, bans on industry and market entry, and investigation of criminal responsibility for crimes involving serious violations of the law are the main content
.
According to the data, a total of four "Notices on Unannounced Medical Device Inspections" were issued in 2020.
A total of 35 medical device companies were notified by the state, and Gao singled out 112 defects
.
Facing 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, 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 addition, companies need to focus on the suitability of the quality policy/objectives to achieve the quality objectives; the ability of human resources, infrastructure, and working environment to meet requirements; the main processes and key activities to achieve the expected results; the conformity and stability of the products ; Data collection, analysis, and utilization conditions to continuously improve the effectiveness of measures; internal audit, management review, and the effectiveness of corrective/preventive measures-self-correction and self-improvement mechanisms; the degree of compliance of the documented system with standards; the degree of implementation of the documented system
.