Recent，The State Drug Administration organized an unannounced inspection of Tianjin Vivadentai Biotechnology Co., Ltd。Checking，The following deficiencies were found in the company's quality management system：
One、机构与人员方面
企业2017年5月1日任命管代，However, the actual work is sales and research and development，The company has not taken steps to raise awareness among employees of the requirements of the quality management system，It does not comply with the "Good Manufacturing Practice for Medical Devices" (hereinafter referred to as the "Specification") in which the management representative is responsible for the establishment、Implement and maintain a quality management system，Report on the operation of the quality management system and the need for improvement，Improve employee compliance with regulations、Requirements for the awareness of regulations and customer requirements。
Two、设备方面
企业未配置检测X射线阻射项目的设备，Testing has not been commissioned，Enterprises that do not comply with the "Specification" shall be equipped with inspection instruments and equipment that are compatible with the product inspection requirements，The main inspection instruments and equipment shall have clear requirements for operating procedures。
Three、设计开发方面
企业产品设计开发输出资料未包括产品配方，The following performance index requirements in the product technical requirements are not included：X-ray blocking、Tensile bond strength、Shear bond strength、Composition and percentage，The design and development output of enterprises that do not comply with the "Specification" shall meet the input requirements，Procurement is included、Information required for production and service、requirements for product technical requirements, etc。
Four、生产管理方面
（一）企业工艺流程图（SC-SOP-01，Edition B/2017) stipulates the process as follows:：Raw material procurement, inspection, material breaking, lathe processing, polishing, curing, cleaning, inspection, packaging, warehousing，The company changed the actual production process to lathe processing - material breaking，Failure to compile material cutting process regulations and work instructions，Spot check production records (JL-7.5-03, fiberglass piles，Specification and model VIVAdental-V3, production batch number 180608) changed the production process as:：Wash - cure，Enterprises that do not comply with the "Specification" shall prepare production process regulations、Work instructions, etc，Clarify the requirements of key processes and special processes。
(2) Spot check the production records of enterprises (JL-7.5-03，Fiberglass piles，Specification model VIVAdental-V3, production lot number 180608)，The batch quantity is not recorded、Process parameters、Main equipment，Each batch (Taiwan) of products that do not comply with the "Specification" shall have production records，and meet the requirements of traceability。
Five、质量控制方面
企业产品检验规程未涵盖经注册的产品技术要求中的如下性能指标：Flexural performance、Flexural modulus of elasticity、X-ray blocking properties、Tensile bond strength、Shear bond strength、Composition and percentage，Enterprises that do not comply with the "Specification" shall formulate product inspection procedures according to the mandatory standards and the technical requirements of the products that have been registered or recorded，And the requirements for issuing corresponding inspection reports or certificates。
Tianjin Vivadentai Biotechnology Co., Ltd. has confirmed the deficiencies in its quality management system。The above behavior of the enterprise did not comply with the relevant provisions of the Good Manufacturing Practice for Medical Devices，There are serious deficiencies in the production quality management system，The State Drug Administration instructed the Tianjin Municipal Commission for Market and Quality Supervision to order the enterprise to immediately suspend production for rectification in accordance with the law，For those involved in violation of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council) and relevant laws and regulations，Handle it seriously in accordance with the law。At the same time, the Tianjin Municipal Market and Quality Supervision and Administration Commission was instructed to require the enterprise to assess product safety risks，It may lead to potential safety hazards，It should be in accordance with the provisions of the "Administrative Measures for the Recall of Medical Devices" (Order No. 29 of the State Food and Drug Administration).，Product recall。
Production can only be resumed after the enterprise completes all project rectification and is qualified by the Tianjin Market and Quality Supervision and Administration Commission。
Notice is hereby given。
State Food and Drug Administration
2018October 18
Recent，The State Drug Administration organized an unannounced inspection of Nanjing Yigao Microwave System Engineering Co., Ltd。Checking，The following deficiencies were found in the company's quality management system：
One、设备方面
物料称量未配置合适的称量设备，Such as in warehouse 1，The transformer material is placed in a dense manner without packaging，Some of the transformer insulation was scratched，Detection of the number of stainless steel bars in and out of the warehouse，Managers say that the weighing method is used to determine this，During verification, it was found that the stainless steel strip was sagging to the ground，Cannot be weighed accurately，Enterprises that do not comply with the "Good Manufacturing Practice for Medical Devices" (hereinafter referred to as the "Specification") shall be equipped with appropriate measuring instruments，The measuring range and accuracy of the measuring instrument shall meet the requirements of use，Measuring instruments shall be marked with the validity period of their calibration，Requirements for keeping appropriate records。
Two、设计开发方面
企业高频手术系统双极凝模式功率输出从0—120W变为0—80W，Failure to provide confirmed design change materials，It does not meet the requirements of the Code that enterprises should identify and keep records of changes in design and development。
Three、生产管理方面
现场核实高频电刀（编号16121506），The company failed to provide relevant production inspection records，Not traceable，Each batch (Taiwan) of products that do not comply with the "Specification" shall have production records，and meet the requirements of traceability。
Four、质量控制方面
企业未能严格按照国家强制性标准制定出厂检验规程及检验，GB9706.4 requires a high-frequency leakage current to test the load resistance of 200 ohms，Test resistance 200 ohms，Line spacing 50cm，The load resistance for the operator is 400 ohms，Test resistance 200 ohms，Line spacing 25cm for testing，Spot check cable withstand voltage test during the production process，The operating procedure requires 10s to 1000V，Hold for 1min；Actually 20s to 1000V，Keep it for 40s，In the finished product inspection，The high-frequency leakage current test requires 10s to 1000V，Hold for 1min，Actually in 18s it rises to 4000V，Hold for 42s，Enterprises that do not comply with the "Specification" shall formulate product inspection procedures according to the mandatory standards and the technical requirements of the products that have been registered or recorded，And the requirements for issuing the corresponding inspection report or certificate。
Nanjing Yigao Microwave System Engineering Co., Ltd. has confirmed the defects in its quality management system。The above behavior of the enterprise did not comply with the relevant provisions of the Good Manufacturing Practice for Medical Devices，There are serious deficiencies in the production quality management system，The State Drug Administration instructed the Jiangsu Provincial Food and Drug Administration to order the enterprise to immediately stop production and rectify in accordance with the law，For those involved in violation of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council) and relevant laws and regulations，Handle it seriously in accordance with the law。At the same time, the Jiangsu Provincial Food and Drug Administration was instructed to require the company to assess product safety risks，It may lead to potential safety hazards，It should be in accordance with the provisions of the "Administrative Measures for the Recall of Medical Devices" (Order No. 29 of the State Food and Drug Administration).，Product recall。
Production can only be resumed after the enterprise completes all project rectification and is qualified by the Jiangsu Provincial Food and Drug Administration。
Notice is hereby given。
State Food and Drug Administration
2018October 18