Recently, the Arongqi Market Supervision and Administration Bureau actively responded to the requirements of the Hulunbuir Market Supervision and Administration Bureau for the risk classification and classification supervision of medical device business enterprises, and launched a series of inspection actions for the hearing aid business enterprises in the whole flag.
In this action, the supervisors focused on checking whether the company's business products exceeded the scope of the record, whether the product purchase channels were legal, whether the purchase inspection record system was established, whether the acceptance records were true, complete and traceable, whether the product registration certificate information was compliant, whether the performance and scope of application of the packaging, labels, instructions and other records were consistent with the registration approval, and whether the business links were in line with the "Medical Device Business Quality Management Standards" At the same time, the regulators also investigated whether some supermarkets sold hearing aids without filing.
During the inspection, the Arongqi Market Supervision and Administration Bureau found that some hearing aid business enterprises lacked legal knowledge related to medical devices, did not establish a purchase inspection record system, and had incomplete purchase inspection records. The regulators ordered hearing aid business enterprises with management deficiencies to make rectifications in strict accordance with the requirements of laws and regulations such as the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Operations, and the Quality Management Standards for Medical Device Operations. In accordance with the principle of "physical examination supervision and service-oriented law enforcement", the supervisors also explained in detail to the enterprise the requirements for the procurement, acceptance, warehousing, storage, sales, and transportation of hearing aid products, and guided the enterprise to operate in accordance with laws and regulations.
In the next step, the Arongqi Market Supervision and Administration Bureau will continue to strengthen the supervision and inspection of hearing aid business enterprises to ensure that enterprises can standardize their operations and make every effort to ensure the safety of hearing impaired patients.
Source: Arong Qirong Media Center
Editor-in-Chief: Zhou Xin Editor-in-Chief: Ma Haiwen Supervisor: Hou Yuefeng Producer: Chen Yuhang Director: Su De Statement: Please indicate the source of the WeChat public account of "Hulunbuir Release" for reprinting