All of the country's machinery dealers and medical institutions have started special rectification!

Medical Network April 27

The medical device industry is about to usher in an intensive, precise and nationwide special major rectification campaign. A group of illegal and irregular operating companies will be cleared out of the industry, and more operating companies and user organizations will face fines and other administrative penalties. .

Recently, the country drug The Supervision and Administration Bureau formally issued "Strongly Cracking down on Illegal Operation and Use in 2018 medical instruments Special rectification work program, decided to carry out a special rectification campaign nationwide from May to the end of November this year.

The special rectification activities are under the unified leadership of the State Drug Administration, and the provincial, municipal, and county-level drug administration departments are responsible for the implementation. The six-month period is divided into self-examination, rectification, supervision and inspection, case investigation, key spot checks, and summary supervision.

This will be another national large-scale industrial rectification campaign launched by the State Drug Administration after the storm of rectification of illegal business practices in the medical device circulation field in 2016. It is also the year of the medical device industry determined by the National Medical Device Regulatory Conference in 2018. One of the highlights.

(1) Conduct a thorough investigation of the conduct of medical devices without a license (recording) for business and online sales.

(2) Examine the operation (network sales) and the use of medical devices that have not obtained a registration certificate or a filing certificate.

(3) Examine the product behavior of high-intensity injection sodium hyaluronate, condoms, contact lenses, etc. that are of high concern for illegal operations.

(IV) Examining the operation of the third type medical device enterprise The implementation of "medical equipment business quality management practices" situation.

(5) To check the implementation of the "Measures for the Administration of Medical Device Use Quality Supervision".

In 2016, the State Food and Drug Administration announced No. 112 bulletin to launch a special campaign to rectify the behavior of the medical machinery circulation business. This special rectification is aimed at all enterprises engaged in the second and third types of medical device operations and is facing a total of eight illegal activities.

Compared with two years ago, the State Food and Drug Administration launched a special rectification campaign for the medical device industry. The object of its rectification was not only the second and third types of textile machinery, but all medical equipment manufacturers in the country. .

However, the third category of machinery is still the focus. The program requires that the third category of machinery vendors be promoted to implement the GSP specification of the medical apparatus and be inspected by means of flight inspections and cross-checks.

Remediation is also more targeted, focusing on unlicensed operations, and the operation and use of unlicensed medical devices.

This is exactly the oldest problem in the industry.

According to the 2017 Annual Statistical Report on Food and Drug Administration of the State Administration of Food and Drugs, in 2017, the drug administration investigated a total of 17,000 medical device cases, the value of goods was 180 million yuan, the fine was 430 million yuan, and the amount of illegal income confiscated was 19.911 million yuan. 161 unlicensed businesses were banned, 31 counterfeit counters were dismantled, 98 households were ordered to suspend operations, 13 were revoked, and 62 were handed over to the judiciary.

In the past year, another 161 unlicensed medical device companies were cleared out of the industry. Among the 17,000 cases, a total of RMB 450 million in fines was due to unlicensed medical devices.

Cases of administrative penalties relating to unlicensed medical devices broke out one after another. The parties involved were individuals, small traders, multinational corporations, domestic listed companies, and a large number of medical institutions at all levels across the country. Many fines were also imposed on cases. Not low, hundreds of thousands, over a million, millions...

Medical institutions have become important parties in the case of unlicensed medical devices. hospital The use of color-separation equipment that has not been registered in accordance with the law, Yunnan Province, locked 23 brands imported color Doppler ultrasound equipment suspected of smuggling refurbished. Fujian province and some other health centers used by some hospitals imported automatic biochemical analyzers are also not registered according to law, Without qualification documents.

The special rectification launched by the State Food and Drug Administration this time, nearly one million medical institutions - the use of medical equipment used in this link has also been included in the scope of the rectification, the medical device industry is very good.

The requirements of the national bureau plan, the unified arrangement of the provincial pharmaceutical supervisors, and the strengthening of the training of the grass-roots supervisory departments and users of the units. The use units of the municipal jurisdictions of drug administration organizations in their respective jurisdictions conduct self-inspection of the quality management of medical devices, and carry out random checks. The use of the unit in question must supervise the rectification, and must strictly investigate and deal with violations of laws and regulations.

In addition to medical device companies, medical institutions also need to conduct self-examination and rectification. Nearly one million medical institutions across the country will welcome a violation of laws and regulations such as the use of unlicensed medical devices, use of unqualified medical devices, and unauthorized purchase of medical devices. Special verification.

In addition, on March 1st this year, the Measures for the Supervision and Administration of Medical Device Network Sales began to be implemented. The method is clear. Both companies and third-party platforms that engage in the sale of medical device networks must have licenses or record vouchers, and must also comply with the relevant medical devices. of Regulation , Regulations and Specifications.

Collaboration with the launch of the New Regulations on the sale of medical devices for sale on the Internet, this special rectification has also included the online sales of medical devices in the scope of remediation.

The focus of rectification is also on the sale of medical equipment without registration, and on the illegal sale of unlicensed products on the Internet.

In 2017, the Food and Drug Administration of China had used sodium hyaluronate for injections and contact lenses as key varieties and launched special rectifications for medical equipment for online sales. As a result, 1,509 illegal websites were investigated and handled, and 197 illegal and infringing companies were ordered to be rectified. Enterprise 440. In addition, also interviewed Baidu, Tencent, Jingdong, Ali and other sites.

This special rectification, hyaluronic acid, condoms, contact lenses are still listed as a rigorous product.

Judging from the plans of the State Council, the special rectification is highly targeted and strict.

The State Bureau requires that violations of laws and regulations discovered in the rectification be handled in a timely manner. The punishment must be punished. The exposure must be exposed. The revocation license must be revoked and the transfer must be transferred to the public security authority. In batches, clean up batches, investigate and deal with batches, and banned a batch of illegal and irregularly operating enterprises, they must take serious work disciplines, do not implement the work, supervise and inspect the passing of the courts, and the investigation and handling of the cases are not effective. If the report is erroneous, dereliction of duty or dereliction of duty, the relevant personnel shall be investigated for responsibility.

A new wave of industry rectification storms has already begun. It is expected that some medical device companies and natural persons will be removed from the industry, and the medical device industry will be decontaminated and eliminated. This may also indicate that even if the organization reforms, the drug regulatory agency The supervision of the industry's violation of laws and regulations will not be relaxed!