Source: 21st century business herald
On June 5, the Shanghai yangpu district market supervision bureau fined the Shanghai dean medical examiner for more than 800,000 yuan for its use of unlawfully registered medical devices. On May 17, symerfly technology (China) co., LTD. Was fined nearly 800,000 yuan for operating unlawfully registered medical devices.
Within a month, two well-known IVD companies at home and abroad have been sent, in the industry point of view, the agency of Shanghai to investigate and punish the unlicensed medical apparatus and instruments of strength increasing, YiXie industry unprecedented strengthening. And the punishment is more bright refinement, such as in shandong province on May 26, eat food and drug administration issued about for food and medical equipment administrative penalty discretion benchmark (draft).
The quality supervision of medical devices will become a trend and the regulation of products such as medicines and health products will be tightened, according to the company's founder.
According to understand, hubei enshi ", tianjin binhai new area, jiuquan city, gansu province, sichuan suining city and other cities, starting in June for 2-3 months "look back" centralized regulation of medical equipment.
Multiple companies were fined
This year as of June 7, the national food administration of drug safety has released the 12 national medical instrument quality bulletin, a large number of enterprises was found quality does not conform to the standards, or label instructions such as compliance, far more than to any number in a year a year.
Such as the 12, 2017 published by the state food administration of drug safety, according to the national medical instrument quality announcement by sampling is not in conformity with the standards of medical equipment products, involving 3 companies a variety of three; If the project is not conforming to the standard, such as the label and the specification, it refers to a variety of 8 units of five enterprises; The spot check project meets the standard set of 24 enterprises with a variety of 32.
Hangzhou a medical equipment enterprises, said an official with the country this year to YiXie enterprise strengthening supervision: "the agency to the factory inspection many times in six months, the provinces and cities, and check the project more and more thin."
With sampling was intensified, the surveillance authorities investigate production, management, use of unlicensed medical equipment the storm, more and more companies were found to do not conform to the prescribed standards, a fine large number of companies are also more and more.
In addition to the diagnosis and the dean's fly, such as on April 14, bo can China medical equipment (Shanghai) co., LTD for running do not conform to the standards of medical devices also was fined 970000 yuan.
In addition to domestic equipment, multinational companies are also severely regulated and even punished
An important sign is that future regulatory penalties or "price tags". On May 26, in shandong province food and drug administration announced "the shandong province food and drug administrative penalty discretion benchmark (medical devices) (draft)", comment publicly on June 10th.
An unnamed the personage inside course of study points out, "the draft" punishment basis and types, all from regulations of medical equipment and other industries the laws and regulations, or everywhere will follow the reference directly.
National regulations are tightening
"The penalty is a means of promoting the quality of the enterprise and regulating the production and operation of the enterprise." In addition to the above reasons, the regulator is trying to promote more domestic alternatives by improving quality. The punishment also comes with a number of policies for medical devices.
In March 2014, the CFDA issued a new regulation on the supervision and administration of medical devices, and then issued a set of regulations. Among them are registered procedures, clinical trial regulations, production quality management specifications, etc. On March 23, 2016, the CFDA issued the regulations on the quality of clinical trials of medical devices.
In January of this year, in the national food and drug supervision and administration work and the commendation meeting, advanced the CFDA director jingquan, points out that will be carried out in 2017, the outstanding problem big improvement, focus on food, drugs, medical devices and cosmetics production and sales of adulterating fraud and other illegal ACTS, to hunt down all kinds of "hidden rules".
This year, the regulator will conduct quality sampling and risk monitoring for 68 medical devices with high security risks, high consumption and high social attention. At the same time, specific requirements for supervision inspection, sample confirmation, verification and information disclosure are made.
"At present, the most provinces has launched a special field of drug circulation" look back "action, this is to continue to deepen the regulation effect of last year, at the same time cooperate with" two votes "such as the new fall to the ground." Shi lichen analyzed.
On May 12, such as, jiuquan city food and drug administration issued the jiuquan city medical equipment circulation field illegal conduct during the "look back" work plan ", to the city's all engaged in class ii and class iii medical device operation enterprise (including specially engaged in), from late may to late August for a three-month centralized regulation.
On May 25, the tianjin binhai new area issued the binhai new area market regulatory authority to carry out the circulation field of medical equipment management behavior rectification work plan, from August 5th June 5 solstice of jurisdiction is engaged in the second, three types of medical equipment business for 2 months. On May 27, the city of suining also launched a similar crackdown.
At the same time, a multi-sectoral regulatory system is under way. Start medicine such as the national more tax special rectification, including tianjin deparment and so on more than the national tax authority, tax bureau have been issued the "carry out the work of rectification of pharmaceutical industry joint notification" and other documents, officially landed in 2017 tax inspection key work arrangement. Deparment will state taxation bureau in tianjin and the tianjin market supervision committee drug cosmetics circulation regulation, medical equipment distribution regulation in joint to carry out the special medicine for 2017.