At the beginning of 2016, after the sensational Shandong vaccine case, the State Food and Drug Administration successively launched a national special rectification of illegal and illegal activities in the field of drugs and medical devices. The action made the entire pharmaceutical industry screaming and self-defeating.
Among them, the rectification announcement in the field of medical device circulation (the No. 112 Announcement of the State Food and Drug Administration) was released on June 6, 2016, and it has been exactly one year.
2016 has passed, and since 2017, most provinces in the country have started the “review†campaign for special rectification in the field of drug circulation. On the one hand, it is necessary to consolidate the results of last year’s rectification, and on the other hand, it is to cooperate with the “two-vote systemâ€. The implementation of the New Deal will expand the effect of rectification.
After the medicine, it will be a medical device. The author has noticed that as of now, there have actually been some places to take the lead in action, and the “reviewing†action of the nationwide medical device circulation rectification has quietly kicked off, and some “Xinghuo†have also opened up.
The following are some of the areas where the first action is taken and their respective remediation priorities:
1. Suining City, Sichuan Province
On May 27th, Suining City Food and Drug Administration issued the "Work Plan for the Special Remediation of Illegal Behaviors in the Field of Medical Device Circulation in Suining City" and decided to use three months for centralized rectification.
Remediation target: Second and third class medical device operating enterprises in the jurisdiction.
Remediation time: June 1st - August 31st.
In June, the company self-examined and rectified and rectified the time.
In July, the drug supervisor will conduct a comprehensive inspection of the 100% coverage of the operating enterprises against the key content of the remediation.
In August, the drug supervisor will take a “double random†and flight inspection method to conduct random checks on the operating enterprises. The second-class operating enterprises shall have a minimum of 10% of the spot checks, and the third-class operating enterprises shall have a minimum of 20% of the spot checks. All cold chain management, implanted and interventional medical device operators shall be spot-checked.
Remediation focus: a total of 10 violations of the law.
1. Medical device purchase and sales channels are illegal;
2. Failure to comply with medical device management quality management regulations;
3. Obtain illegal business licenses (recording documents) and forgery, sale, lease, and lending business licenses (recorded documents);
4. Persons in charge of key positions such as quality in charge are not on the job;
5. Unauthorized change of the business premises or warehouse address, expansion of business scope or the establishment of warehouses without authorization;
6. Engaged in the third type of medical device business activities without permission;
7. Operate the second and third types of medical devices that have not obtained the registration certificate;
8. Operating non-qualification documents and medical devices that have expired, expired or eliminated;
9. The medical device manuals and labels that are in operation do not meet the requirements, are not transported, stored, and chain-chained to manage medical devices;
10. Failure to establish and implement the medical device quality management system, especially the purchase inspection and sales record system.
With low-power, miniature size, the serial communication department range sensor with mm accuracy can measure up to 20m, 40m, 60m, 100m, 150m, 200m.
If you want to connect our laser range sensor boards together with your computer, you can directly choose the model with one USB connector.
In your project, you can use our distance sensor panel to measure a distance.
Serial Laser Distance Sensor,Serial Communication Laser Distance Sensor,Laser Range Sensor Boards,Distance Sensor Panel
Chengdu JRT Meter Technology Co., Ltd , https://www.infrareddistancesensor.com