Anuncio Nacional Oficial: Resultados de la Inspección de Riesgo de Dispositivos Médicos

In March this year, the National Medical Products Administration (NMPA) issued the "Notice on Carrying Out the Investigation and Rectification of Potential Quality and Safety Risks of Medical Devices", deploying the investigation and rectification work. It identified 9 categories of products and enterprises as key focuses for the campaign, including epidemic prevention and control medical devices and selected products from centralized volume-based procurement.

As of June 25, the progress of the investigation and rectification of potential quality and safety risks of medical devices carried out in various provinces (autonomous regions and municipalities directly under the Central Government) is as follows:

On April 16, the Guangdong Provincial Medical Products Administration issued the "Notice on Doing a Good Job in the Investigation and Rectification of Potential Quality and Safety Risks of Medical Devices", requiring strengthening risk management in the production, operation and use of medical devices and further improving the quality and safety assurance level.

On April 21, the Fujian Provincial Medical Products Administration issued the "2021 Work Plan for the Investigation and Rectification of Potential Quality and Safety Risks of Medical Devices".

On April 22, the Beijing Municipal Medical Products Administration organized and held a meeting on key supervision work of drugs and medical devices and the deployment of investigation and rectification of potential quality and safety risks in the city, aiming to strengthen risk governance, improve the quality and safety assurance level of drugs and medical devices in Beijing, and promote the high-quality development of the pharmaceutical industry.

On April 26, the Inner Mongolia Autonomous Region Medical Products Administration organized and held the first quarter regional medical device supervision risk consultation meeting in 2021, notified the risk monitoring situation, analyzed and assessed the severity and possible hazards, and studied and formulated disposal measures.

On April 26, the Henan Provincial Medical Products Administration issued the "Work Plan for the Investigation and Rectification of Potential Quality and Safety Risks of Medical Devices", deploying and putting forward requirements for strengthening the risk supervision of medical devices.

On April 26, the Guangxi Zhuang Autonomous Region Medical Products Administration held the second quarter post-marketing supervision risk consultation meeting on medical devices in 2021 in Nanning. The meeting sorted out the potential quality and safety risks of medical devices found in the first quarter investigation and supervision, analyzed the causes of regulatory risks, studied effective methods for preventing and controlling different types of risks, and deployed the next step of risk prevention work.

On April 27, the Hubei Provincial Medical Products Administration announced the Work Plan for the Investigation and Rectification of Potential Quality and Safety Risks of Medical Devices in Hubei Province. It required drug regulatory departments at all levels in the province to carry out the investigation and rectification through various forms such as cross-inspection, joint inspection, entrusted inspection, follow-up inspection, third-party evaluation, and "Internet + supervision", conduct "look-back" inspections on key enterprises, severely investigate and punish illegal and irregular behaviors, and strengthen typical demonstrations.

On April 28, the Gansu Provincial Medical Products Administration organized market supervision departments of some cities and prefectures to hold the first quarter medical device quality and safety risk consultation meeting. At the meeting, the person in charge of medical device supervision of market supervision bureaus in Lanzhou, Wuwei, Baiyin, Lanzhou New Area and other cities and prefectures deployed the investigation and rectification of potential quality and safety risks of medical devices, promoted comprehensive self-inspection of enterprises, and put forward specific and feasible opinions and suggestions on how to carry out the investigation work well.

On May 10, on the basis of holding four sessions of medical device laws and regulations training courses across the region in Urumqi and Turpan, the Xinjiang Uygur Autonomous Region Medical Products Administration held a forum on the investigation of potential quality and safety risks of medical devices.

On May 13, in accordance with the relevant requirements of the NMPA on the investigation and rectification of potential quality and safety risks of medical devices, the Zhejiang Provincial Medical Products Administration made careful deployment, steadily promoted the work, and strived to improve the efficiency of medical device risk governance in Zhejiang.

On May 18, the Chongqing Municipal Medical Products Administration issued a notice, deploying the comprehensive promotion of the investigation and rectification of potential quality and safety risks of medical devices across the city. The notice clarified that the campaign aims to strengthen medical device risk management, further improve the quality and safety assurance level, effectively prevent and resolve safety risks, and promote the high-quality development of the medical device industry.

On May 31, the Yunnan Provincial Medical Products Administration issued a notice, deploying the investigation and rectification of potential quality and safety risks of medical devices.

From June 7 to 11, the Shanghai Municipal Medical Products Administration organized the 2021 medical device inspector training and mobilization meeting for special unannounced inspections on risk investigation and rectification. The meeting emphasized earnestly implementing the requirements of the municipal government and the NMPA's notice on risk investigation and rectification, doing a good job in three key tasks including risk investigation and rectification, risk consultation and standardization, firmly adhering to the bottom line of product safety, and ensuring public safety in the use of medical devices.

The Sichuan Provincial Medical Products Administration organized and held the first quarter medical device quality and safety supervision risk consultation meeting. The meeting summarized the investigation and rectification of potential medical device risks in the first quarter and analyzed and assessed 142 risk points in the production link.

The Tianjin Municipal Medical Products Administration organized and held the second quarter medical device production supervision risk consultation meeting in 2021. The meeting identified the control of the "flame retardancy" index of medical protective clothing as the main risk point, and listened to the control methods and expected effects of the "flame retardancy" index adopted by representatives of various manufacturers. Combined with the situation that enterprises' research on the "flame retardancy" index is not in-depth and the control is not in place, the meeting put forward risk prevention and control suggestions, namely implementing hierarchical management of products, distinguishing specifications and models according to product use scenarios, and clearly indicating them in the instructions and labels.

In the process of carrying out the investigation and rectification of potential quality and safety risks of medical devices, the Liaoning Provincial Medical Products Administration strengthened the investigation and inspection of manufacturers, distributors and user institutions in combination with the implementation of the "Regulations on the Supervision and Administration of Medical Devices".

The Hebei Provincial Medical Products Administration actively carried out the investigation and rectification of potential quality and safety risks of medical devices, focusing on 9 aspects including epidemic prevention and control medical devices, selected products from centralized volume-based procurement, sterile and implantable medical devices, and online sales of medical devices. Since May, a total of 984 potential risks have been identified, 959 have been eliminated, and 11 long-term mechanisms have been established.

To further strengthen the quality supervision of medical device products in Guizhou and effectively maintain the market order, in accordance with the requirements of the "Notice on Carrying Out the Investigation and Rectification of Potential Quality and Safety Risks of Medical Devices in Guizhou Province", the Guizhou Provincial Medical Products Administration conducted unannounced inspections on some medical device distributors and user institutions.

Combined with the key points of medical device supervision work in the province and the "two products and one device" supervision and inspection plan, the Hunan Provincial Medical Products Administration formulated the "2021 Work Plan for the Investigation and Rectification of Potential Quality and Safety Risks of Medical Devices in Hunan Province", clarifying work objectives, principles, arrangements and requirements, determining key points for investigation and rectification, and comprehensively sorting out and investigating potential risks.