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Medical device supervision storm resurgence, many places and many enterprises were fined

Author : HES Medical Time :

Shanghai Yangpu District Market Supervision Bureau of the dean of Shanghai Medical Laboratory Limited about 800000 yuan punishment, because of its use of medical devices is not legally registered; in May 17th, Thermo Fisher Scientific (China) Limited for the medical device operation is not legally registered, also fined nearly 800 thousand yuan.

Within a month, both at home and abroad well-known IVD companies have been fined, in the industry view, the Shanghai authorities dealt with unlicensed medical devices has intensified, Yixie industry unprecedented strengthening supervision. In addition, penalties have become more detailed, such as May 26th, Shandong food and Drug Administration issued a consultation on food and medical equipment administrative punishment discretion standard (Draft) opinion.

Max kanglai founder Shi Lichen to the twenty-first Century economic report reporter pointed out that the medical device quality supervision strictly will become a trend, and the drugs and health care products and other products will also be more strict supervision.

It is also understood that Hubei, Tianjin Binhai New Area, Gansu, Jiuquan, Sichuan, Suining and other cities, from June to start a period of 2-3 months, "medical equipment" "look back" centralized treatment of Enshi.

Many enterprises have been fined

As of June 7th this year, the State Food and drug administration has issued the 12 national medical equipment quality bulletin, a large number of enterprises were found substandard quality, or labels, manuals and other irregularities, far more than the past year of any year.

As of 2017 Twelfth National Medical Quality Bulletin of the State Food and Drug Administration released by sampling does not meet the standard requirements of medical products, involving 1 varieties of 3 enterprises of 3 Taiwan; sampling to identify the labels and instructions do not conform to the prescribed standards, involving 5 enterprises of 1 varieties of 8 Taiwan check all meet the standard requirements; the 24 companies of the 1 varieties of 32 taiwan.

Hangzhou, a medical device company official said the twenty-first Century Economic Herald reporter, this year the state of medical enterprise supervision strengthened: "in the first half, the provincial department repeatedly to factory inspection, and check the project more and more fine."

With the increase of sampling intensity, the supervision department has begun to investigate the production, operation and use of unlicensed medical device storm. More and more enterprises have been found not to meet the standard requirements, and the number of enterprises sentenced to high fines is also increasing.

In addition to the diagnosis and the thermo Dean fly outside, as of April 14th, bonovo medical equipment (Shanghai) Co., Ltd. for the medical device operation does not meet the standard requirements also be fined about 970 thousand yuan.

In addition to domestic equipment, multinational enterprises have also been severely regulated and even punished.

A signal that can not be ignored is the future regulatory penalties or "marked price."".  In May 26th, Shandong province food and Drug Administration announced the "Shandong provincial food and drug administrative penalty discretion benchmark (medical devices) (Draft)", in June 10th before the public comment.

An unnamed industry insiders pointed out that the "draft" punishment basis and type, are from the medical device regulatory regulations and other industry laws and regulations, or will directly follow the reference.

National supervision tends to be strict

"Fine" is a means to promote enterprises to improve quality and standardize production and operation." Shi Lichen analysis, in addition to the above reasons, the regulatory authorities want to improve the quality, to promote more domestic substitution import. At the same time, several medical device industry policies have also been introduced.

In March 2014, CFDA issued a new version of the medical device supervision and management regulations, and then issued the corresponding laws and regulations.  Among them, the registration procedures, clinical trial regulations, production quality management standards, and so on; in March 23, 2016, CFDA issued the "medical device clinical trial quality management specification".

In January this year, the national food and drug supervision and management work and commend advanced meeting, CFDA director Bi Jingquan pointed out that 2017 will carry out outstanding issues remediation, focusing on remediation illegal food, medicines, medical devices and cosmetics production and sales of adulteration, thorough investigation of all kinds of "unspoken rule".

It is reported that this year, the regulatory authorities will carry out quality sampling and risk monitoring inspection of 68 kinds of medical devices with high safety risk, large consumption and high social concern. At the same time, the specific requirements for supervision and inspection, sample confirmation, verification, disposal and information publicity are put forward.

At present, most provinces have started the special rectification of drug circulation field, which is to deepen the effect of last year's rectification, and to implement the new deal with the "two votes system"." Shi Lichen analysis.

Twenty-first Century Economic Herald reporter found that the national medical circulation regulation "look back" has been carried out.

As of May 12th, the Jiuquan Municipal Food and Drug Administration issued the "Jiuquan medical device circulation of illegal business activities focus on remediation of" looking back "plan", the city all engaged in the two category, three types of medical equipment enterprises (including college run), from late May to late August to carry out concentrated rectification for a period of 3 months.

In May 25th, Tianjin Binhai issued "Binhai Market Supervision Bureau to carry out the work program" medical device circulation business conduct special rectification, for a period of 2 months from June 5th to August 5th on the area of renovation in second, third types of medical equipment enterprises. In May 27th, Suining also carried out similar rectification.

At the same time, multi sectoral joint supervision is also being carried out. For example, the special rectification of medical taxation has been launched in many places in China, including the Taxation Bureau of Tianjin State Taxation Bureau and many other tax authorities throughout the country