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|Baidu put into production medical devices before altering business information, suspected of administrative violations, dumb momoko xu chue fern|
|Author: Anonymous Medical Devices: Site author Hits: Updated: 2019-3-15|
In addition, Baidu had been hinted that during the research and development period, the Baidu team at the National Blindness Prevention Office at Beijing Tongren Hospital sent the physical machine to the field for testing by experts. The scale is 100, showing results, and the same-sex has reached 94%. It is active and special. The number of doctors who read the film spans most of them, and the degree of the chief physician is close to the top three hospitals.
Whether the manufacturer of the screening machine is a company owned by Baidu. For the fundraising of Baidu AI, which was previously donated and put into use, it is not convenient to disclose Song Guangping's hint in several types of medical devices and the device.
In addition, the State Food and Drug Administration requires that branches established in accordance with national food and legal entity units should apply for the "Medical Device Operating Enterprise License" to operate legal entity units, unincorporated entities, and legal entity units of the second and third categories of medical device products. There are rules.
According to Article 63, according to the Regulations, the unauthorized disposal of Class III medical devices in the production of Class II, Class I, and the disposal of medical devices in operation Class III, the production and operation of medical devices and Items, equipment, raw materials and other items produced and operated illegally shall be confiscated by the food and drug surveillance department of the people's authority at or above the county level for illegal income and illegal students; medical devices with a value of less than 10,000 yuan shall be fined and operated under 100,000 yuan. A penalty of more than 50,000 yuan; a fine of more than 10,000 yuan; a fine of more than 20 times; a fine of 10 times the value of the goods; severe circumstances; the application for a medical device license filed by the enterprise will not accept the relevant obligor and the license within 5 years; The production and operation of the second and third types of medical devices have not obtained medical device registration. In severe cases, the license or medical device operation permit is partially revoked from the original issuing of the medical device.
The enterprises, institutions, or individuals who donate medical devices according to the Medical Device Supervision, but donate medical devices in accordance with the relevant legal certification documents for medical devices, should be supervised. Donors must not donate medical devices that have not been registered or prepared in accordance with the law, that have been cut off, and that are outdated and invalid.
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Today's war, today, the reporter contacted the Beijing News reporter of the Anti-Blindness Office. The staff hinted that once working, the detection of the fundus screening machine has not been rumored to be Baidu AI. The unit in the hospital "We are medical and the testing equipment business has not given Enterprise inspection. "
Lawyers said that Fan Chen, the Supervision of the Regulations was delimited according to the "Medical Device Supervision, Device Implementation of Product Registration for Second and Third Class Medical Treatment, and Sales and Donation Registration Before Registration." According to the scope of its use, "the fundus screening machine, the screening device is for human lesions, medical equipment belongs to the class. Regardless of the number of medical devices, no matter what kind of quality, without obtaining funds under the premise of quality, illegal acts are . "
The Regulations on Supervision and Administration stipulated that the "Medical Device Supervision, Enterprise or Other Institutions, Personal Donation Medical Devices Utilization Unit Takes Over the Production and Operation of Medical Devices, and the relevant legal certification documents of the donors shall provide medical devices, and the relevant designation shall be carried out. The inspection of the grantee should be done in accordance with the appropriate requirements. Donors must not donate medical devices that have not been registered or prepared in accordance with the law, that have been cut off, and that are outdated and invalid.
The Beijing News reporter Song Guangping told that the Baidu AI fundus screening all-in-one machine for the empowerment of custom-made smart devices at the lower level is Baidu. The search algorithm is connected to the fundus camera. By screening AI multiple fundus diseases, the dual problem of insufficient capital is dealt with the lower Equipment and medical.
A notice from the General Office of the Health and Family Planning Commission complied with the 2014 National Health Report. Shidang, the National Defense Blind Technology Steering Group adjusted the General Office of the National Health and Family Planning Commission. Same in Beijing. This is the Baidu mention.
The documents provided show that according to Song Guangping, at the end of March, it is estimated that there will be 14 pilot hospitals in Guangdong Province using Baidu AI fundus screening machine, and large-scale AI clinical research will be conducted under the core organization of Zhongshan Ophthalmology.
For this pair, the lawyer Fan Chen said that the legal affairs of Jingshi lawyers, the administrative regulations issued by the State Council, "Medical Device Handling Regulations" are. Before the operation scope was changed, Baidu's behavior was suspected of administrative illegal donation of AI fundus screening.
It has been used before the scope of the camp. Whether Baidu's AI fundus screening machine is changing, Ping hinted that Song Guang and Empower Medical intend to donate the AI fundus screening machine to Baidu AI in accordance with Baidu AI. For poor counties, this is a public welfare donation, and according to the relevant laws of the country and Baidu has also added, related to the scope of operation.
According to Baidu ’s WeChat account, according to Baidu ’s WeChat, on January 1st, among the large-scale free clinics in the lower layer of the intelligent diagnostic system, the ophthalmologist of Guangdong Province was held at the People's Hospital of Deqing County. Fundus photography was performed and the scene was for the citizens, and the results were checked and diagnosed by experts to connect the fundus sieve.
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Wang Ruiwen) February 13 News (Reporter, interest inquiry platform Tianyan checked and learned that Beijing News reporters have changed from Industrial and Commercial Letters, February 11 (hereinafter referred to as Baidu) changes in industrial and commercial news Baidu Online Collection Technology (Beijing) Unlimited , "Selling medical devices, Class II" and other contents, its operating scope has been added "Selling Class III medical devices. Documents provided by member Song Guangping show that according to Baidu's public relations staff, as of January 10, it will be 1 month before the operation scope. That is, the Baidu change. After landing in the four hospitals of Zhaoqing City, the Baidu AI fundus screening machine has been used. The civilian hospital was the first to use it and was born in Deqing County, Zhaoqing City.
On January 16th, on the 16th, another article was published saying that Baidu WeChat was public, and the Qingxian People's Hospital had been on duty for more than three months. The Baidu AI fundus screening machine was in Germany.
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