In 2020, a batch of medical devices will be highlighted for sampling

At present, medical devices have become one of the most outstanding industries in China's high-tech industry, new products are emerging, product quality is constantly improving, mobile medical devices, precision medicine, big data-based products are developing rapidlyAt the same time, domestic medical device manufacturers, operating enterprises have also increased significantly, medical device manufacturers have been close to more than 18,000With the domestic medical device production and operation into a new stage, the state has also put forward new requirements for supervision
Recently, the State Drug Administration announced the "Medical Device Quality Inspection And Inspection Management Measures" (hereinafter referred to as the "Management Measures")Among them, Article 9 of the Administrative Measures clearly requires that the national medical device quality spot checks and inspections will focus on the following medical devices: high safety risks, need to focus on supervision;
In addition, provincial medical device quality inspection requirements are also published in the "Management Measures."
In fact, with the continuous reform of China's medical device industry, all regions have increased their investment in the medical device industryHowever, the situation of medical device industry in various provinces and cities is different, local government and market supervision supervision layer by layer decomposed to the grass-roots level, the supervision responsibility of medical devices has not actually been effectively fulfilled, the regulatory resources are not sufficient, the regulatory thinking needs to be promoted, the boundary of regulatory responsibility is not clear, and the responsibility of the grass-roots regulatory personnel and regulatory functions do not match, resulting in the regulatory work appears blind areas
Therefore, in order to strengthen the quality supervision of medical device products, the state has been constantly improving the Regulations on the Supervision and Administration of Medical Devices, while increasing the quality of medical devices test ingress
It is understood that at present, China's medical device supervision and classification management, divided into pre-market management and post-market management and controlAnd the implementation of risk management model, medical devices are divided into three categories: low risk level (1), with moderate risk (class 2), with higher risk (category 3), the state to implement the record management of 1 type of medical devices, the second and third types of medical devices product registration managementFrom this, it can also be clearly seen that the goal of China's medical device supervision is to ensure the effectiveness and safety of medical device use
In fact, in recent years, with the deepening of medical reform, the state and local are constantly strengthening the supervision of the medical device industryIt is reported that in order to strengthen the quality supervision and management of medical devices recently, to ensure the safe and effective use of medical device products, the former State Administration of Food and Drug Administration organized the artificial crystal, respiratory tract suction catheter (sputum pipe), light treatment equipment and other 7 varieties of 252 batches (Taiwan) of the product son to carry out quality supervision and sampling, a total of 54 batches (Taiwan) products do not meet the standard severity
Recently, the Jiangxi Provincial Drug Administration issued the "2020 No1 Medical Device Supervision and Sampling Information Announcement", announced the 2019 Jiangxi Province medical device sampling compliance, does not meet the standards of the list of productsIt is understood that this sampling does not meet the standard provisions of medical device products a total of 5 batches
With the change of the state's supervision of medical devices, new requirements have been put forward for medical device enterprisesIn the future, from the medical device product classification, registration filing requirements, production supervision and so on, medical device enterprises need to have higher, more standardized requirements for themselves.