On June 5th, Shanghai Yangpu District Market Supervision Bureau punished Shanghai Dean Medical Laboratory Co., Ltd. for more than 800,000 yuan because of the use of unregistered medical devices; on May 17, Thermo Fisher Scientific (China) Co., Ltd. was also fined nearly 800,000 yuan for operating unregistered medical equipment.
Within one month, two well-known IVD companies at home and abroad were fined one after another. In the eyes of the industry, the efforts of the Shanghai drug regulatory department to investigate and certify unlicensed medical devices have continued to increase, and the supervision of the medical and medical industries has been stepped up. In addition, the penalties have become more meticulous. For example, on May 26, Shandong Food and Drug Administration issued opinions on the basis for soliciting administrative penalties for food and medical devices (draft for comment).
Shi Xianchen, the founder of Maxconile, pointed out to reporters that the strict supervision of medical device quality will become a trend, and that the supervision of drugs, health products and other products will also be more stringent.
It was also learned that many cities such as Enshi City in Hubei Province, Tianjin Binhai New Area, Jiuquan City in Gansu Province, and Suining City in Sichuan Province began to conduct a two-month period of 2-3 months of medical device “reviewing†and centralized remediation from June.
Many businesses have been fined
As of June 7 this year, the State Food and Drug Administration has issued 12 national medical device quality announcements. A large number of companies have been found to be inconsistent with quality standards, or label instructions, etc., which are far beyond the standard of any one year. The number of years.
For example, the national medical device quality bulletin released in the 12th issue of 2017 published by the State Food and Drug Administration shows that medical device products that have been sampled for non-compliance with the requirements of the standard involve 3 types of 1 product of 3 companies; the items to be sampled are identification labels and instructions. For those that do not comply with the standards, there are 8 sets of 1 variety involving 5 companies, and there are 32 sets of 1 variety of 24 companies that meet the standard requirements.
A person in charge of a medical device company in Hangzhou told reporters that this year the state has increased its supervision of medical and pharmaceutical enterprises: “In half a year, the provincial and municipal pharmaceutical supervisory departments have visited the factory many times, and inspection items have become increasingly finer.â€
With the increase of sampling inspection efforts, the supervision department has started to investigate and punish the production, operation, and use of unlicensed medical equipment. More and more companies have been found to be inconsistent with the standards, and the number of companies that have been fined a lot has become more and more. many.
In addition to the above-mentioned Dean Diagnostics and Thermo Fisher, on April 14th, Bonenghua Medical Devices (Shanghai) Co., Ltd. was also fined approximately 970,000 yuan for operating medical devices that did not meet the standards.
In addition to domestic equipment, multinational companies have also been severely regulated and even punished.
A signal that can't be ignored is the future regulatory punishment or "clearly priced." On May 26, the Shandong Provincial Bureau of Food and Drugs announced the “Shandong Province Food and Drug Administrative Punishment Benchmark (Medical Devices) (Draft for Soliciting Opinions)â€, which was publicly solicited for comments before June 10.
An industry insider who declined to be named pointed out that the basis and types of punishment for the “Draft for Comment†were derived from industrial laws and regulations such as medical device supervision regulations, and all localities would follow suit.
National supervision tightens
“The fine is a means to promote the quality of enterprises and standardize their production and management.†According to Shi Lichen, in addition to the above reasons, the supervisory department wants to promote more domestic alternative imports through quality improvement. At the same time, a number of medical device industry policies were introduced.
In March 2014, the CFDA issued a new edition of the "Regulations on the Supervision and Administration of Medical Devices", and subsequently released the corresponding regulations. Among them are the registration procedures, clinical trial regulations, and production quality management specifications that have attracted much attention. On March 23, 2016, the CFDA issued the “Quality Management Practice for Medical Device Clinical Trialsâ€.
In January of this year, at the National Food and Drug Supervision and Management Conference and commendation of advanced meeting, CFDA Director Bi Jingquan pointed out that major problems will be rectified in 2017, focusing on the rectification of illegal activities such as adulteration and fraud in the production and sales of food, medicines, medical devices, and cosmetics. Investigate all kinds of "hidden rules".
It is reported that this year the regulatory authority will carry out quality sampling inspections and risk monitoring and inspection of 68 medical devices with high safety risks, high consumption, and high social concerns. At the same time, specific requirements for supervision and inspection, sample confirmation, verification and disposal, and information disclosure were put forward.
“At present, most provinces have started the special rectification of the drug circulation sector to 'look back and see' actions. This is to continue to deepen the effectiveness of last year’s remediation, and at the same time, the “two-vote system†and other new administrations will be implemented.†Shi Lichen analyzed.
The reporter found that the "Retrospective" operation of the nationwide medical machinery circulation remediation has begun.
For example, on May 12th, the Jiuquan City Food and Drug Administration issued the "Look back at the Work Program" for the centralized rectification of illegal business operations in the medical equipment circulation field in Jiuquan City, and it is responsible for all types of medical equipment companies engaged in Class II and III medical equipment (including both ) From the end of May to the end of August, a 3-month centralized rectification will be carried out.
On May 25th, Tianjin Binhai New Area issued the "Working Plan for the Special Regulation of the Operational Behavior of Medical Devices in the Market Supervision Bureau of Binhai New Area". From June 5th to August 5th, it is engaged in the operation of the second and third types of medical devices in the jurisdiction. The company conducts a two-month rectification. On May 27, Suining City also carried out similar rectification.
At the same time, multisectoral joint supervision is also in progress. For instance, the nation’s multi-site taxation reforms, including the National Taxation Bureau of the National Taxation Bureau of Tianjin Municipality and other national tax authorities, have successively issued documents such as the “Jointly Launching a Notification on the Special Remediation of the Pharmaceutical Industry†and officially landed the “2017 Tax Auditing Key. Working arrangements". The Audit Bureau of the Tianjin State Taxation Administration will jointly carry out special rectification of the pharmaceutical industry in 2017 in conjunction with the Pharmaceutical Cosmetics Regulatory Office of the Tianjin Market Supervision Committee and the Medical Device Circulation Supervision Office.
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