Zhejiang Mondial Electronic Technology Co., Ltd.
Officially obtained the production license for medical devices of infrared thermometer
This is the first approved medical infrared thermometer in the city
Enterprises with production qualification
It is also the first enterprise in Sanmen to produce medical anti-epidemic products
A breakthrough in the production of three medical anti-epidemic products has been achieved
On March 18 and 19, Taizhou Municipal Market Supervision Bureau delivered the medical device product registration certificate and medical device production license to Sanmen MEDIOR Electronic Technology Co., Ltd., marking that the first medical infrared thermometer enterprise in the city was licensed for production. Now, MEDIOR Electronic Technology Co., Ltd. is continuously putting into the production of infrared thermometers, with a daily output of 50000 sets. At present, it has received an order of more than 100 million yuan, which will greatly alleviate the shortage of medical infrared thermometers in the market and fill the production gap of three medical anti epidemic products.
MEDIOR Electronic Technology Co., Ltd. was originally an enterprise producing massage equipment. With the coming of the epidemic situation, in response to the industrial layout of medical epidemic prevention products in the province, it has made a good reserve of emergency materials. 18 production lines have been set up by MEDIOR Electronic Technology Co., Ltd. in an emergency to produce medical infrared thermometer. Medical infrared thermometer belongs to class II medical devices, which must be approved by the provincial food and drug administration, and has strict requirements on production technology, production environment, and other indicators. In order to help the enterprises to change production successfully, Sanmen County Market Supervision Bureau took the initiative, actively assisted and set up an expert group to guide the enterprises on site. In order to help the enterprise to pass the examination and approval as soon as possible, Wang Tao, chief of the regulatory department of medical devices, led the staff of the regulatory department of medical devices to work overtime, check and guide the application materials on site, and carry out the detailed transformation in the construction process. He successively visited the enterprise for on-site guidance more than ten times and carried out the detailed management of the enterprise’s system management, various records and the daily disinfection management of the workshop in accordance with the regulatory requirements of medical devices Explain and guide to ensure all conditions can meet the standard. According to the previous process, it will take at least 3 months to get the production license, but now it only takes 10 days from the product inspection to the production license.
On February 28, after receiving the application for increasing the business scope of class II medical devices from MEDIOR Electronic Technology Co., Ltd., Sanmen County Market Supervision Bureau carefully reviewed the relevant application materials of the enterprise, sent special personnel to provide the enterprise with “one-to-one” whole process tracking and guidance services through telephone, wechat and other online ways, and guided the enterprise business scope change registration application materials in the whole process. At the same time, we will open up green channels and special affairs offices, and issue business licenses on the spot. The whole process will only take 20 minutes. During the epidemic period, Sanmen County Market Supervision Bureau took the initiative to provide front-end services, through “online office, hand-held office, mail and delivery office, appointment office” and other ways, specially assigned service and special affairs office, opened the approval “green channel” for enterprises producing epidemic prevention materials, followed and guided the whole process, accelerated the production and supply of epidemic prevention materials, and comprehensively assisted in epidemic prevention and control.
“Hello, what procedures do we need to produce Thermometer guns?””Can the production license of the Thermometer gun be handled earlier?” Since the outbreak of the disease, all kinds of consultation calls have continued. Yu Zhonghai, deputy section chief of the medical equipment supervision department, as a member of the expert group, joined more than a dozen enterprise support groups to help enterprises solve all kinds of problems around the clock. From the morning when he opened his eyes, he began to answer all kinds of consultation calls and reply to wechat information. During the day, they went to various enterprises for on-site guidance, and it was normal for them to wake up by phone in the middle of the night.
For MEDIOR Electronic Technology Co., Ltd., the production of a medical infrared thermometer is a new field. “Medical infrared thermometer belongs to class II medical equipment, and we have no experience in how to approve it. Thanks to the patient answers of comrades from the market supervision bureau, we are guided to obtain the approval with our fingers,” said Ren Changhui, head of MEDIOR Electronic Technology Co., Ltd. In order to help the enterprise to pass the examination and approval as soon as possible, comrades of the medical equipment department have been specially stationed in various enterprises to guide the application of relevant materials. At present, they have guided 8 enterprises to carry out the application of medical anti-epidemic articles. Next, three kinds of medical isolation clothing and medical masks will be put into the market soon!
Chinese Original Version From: 掌上三门