Jiangsu special rectification of illegal use of medical equipment | online and offline synchronization supervision

On August 1st, the State Drug Administration issued a notice on the special rectification work plan for severely cracking down on illegal and illegal use of medical devices in 2018. According to the Jiangsu Food and Drug Administration, Jiangsu Province has launched a special project. Remediation work, by strengthening the supervision of the operation and use of medical devices, severely crack down on violations of laws and regulations, promote the establishment of a long-term regulatory mechanism, and constantly purify the order of the medical device market in the province, and effectively protect the safety of the people.

Medical devices are special products used in the human body. The safety of medical devices is directly related to the life safety of human bodies. There are many types of medical devices, such as contact lenses, condoms, sodium hyaluronate for injection, etc., all of which belong to medical devices. category.

This special rectification will resolutely crack down on the medical equipment business 'black den point' 'black website' 'black platform' 'black door shop', and unlicensed (recorded) engaged in business and online sales of medical equipment, business (network sales) and use Medical device behaviors that do not have a registration certificate or a record certificate, sodium hyaluronate for injection, condoms, contact lenses, etc., which are highly concerned and used in large quantities, are also included in the scope of remediation. The quality of medical devices, quality of use The implementation of the situation is also one of the priorities of this rectification.

The provincial bureau has specially set up a 'Severely cracking down on illegal and illegal use of medical equipment special rectification leading group'. Each district, city, county (district) level food and drug supervision department clearly defined the division of responsibilities, implementation of responsible departments, to ensure that all tasks are in place.

This special rectification will implement the 'offline' remediation and 'online' rectification, and strengthen the focus. enterprise , key products, inspection of key clues, taking the weak links of supervision as the entry point, carefully organizing investigations, regular inspections, and random sampling. Monitoring the sales and transactions of medical devices through the national bureau monitoring platform, and discovering abnormal conditions by all levels of supervision Departments check and dispose of. In case of case investigation, the case will be reported to the State Bureau through the platform in time after the case is closed, and will be announced to the public in time according to the relevant provisions of the government information disclosure. The National Bureau will also regularly report the disposal of monitoring information.

Special rectification will also focus on the implementation of the "Quality Management Standards for Medical Device Management" (hereinafter referred to as "Code"), and comprehensively improve the quality management level of medical device management. Enterprises are required to carry out business activities in accordance with the requirements of the "Code". If the operating conditions of the operating enterprise change and no longer meet the requirements of the "Regulations", in accordance with relevant laws Regulation Serious investigation and punishment, rectification within a time limit. The provincial bureau will organize the supervision and inspection of the implementation of the "Specifications" for some third-class enterprises that operate in vitro diagnostic reagents, sterile and implanted products, and find more problems in special rectification. Complaints and reports, business enterprises that may have quality and safety hazards carry out flight inspections.

At the same time, the unit is required to conduct a self-examination of the quality management of medical device use in accordance with the “Self-inspection Form for Quality Supervision and Management of Medical Device Use”, and establish and implement coverage. purchase Quality management system for acceptance, storage, use, maintenance, etc. The supervisory departments at all levels urge the users who have problems to urge them to make corrections in place, and severely investigate and punish violations. The provincial bureau will also organize supervision of some medical device users. an examination.

Food at all levels drug The regulatory authorities will combine special rectifications, report by media reports and complaints from the public, and report them as clues. medical instruments Hidden risks and outstanding problems in security risks, master key issues and problems, key areas of key areas, key places, key units, establish key rectification accounts. Summarize remediation experience and practices, explore the establishment of targeted long-term supervision mechanisms, and maintain Combating the high pressure situation of illegal violations of medical devices.

At the same time, all localities should carry out popularization, legal education and public warning education activities to publicize the harms and consequences that may result from violations of laws and regulations, and create a good atmosphere for social co-governance.