Medical network - April 11 medical device registration fraud into the penalty charges, will face the most severe punishment. 

 

On April 10, according to the supreme people's court, the supreme law review and principles through the judicial committee plenary meeting of the supreme people's court, the supreme people's procuratorate about deal with drugs, medical devices registration data fraud criminal cases to explain some issues of applicable law (hereinafter referred to as the "explanation"). 

 

Department of the "explanation" for the implementation of the "four most strict" instructions, in accordance with the law to punish drug and medical device registration process the data in the fraud, in July 2016 by the supreme law of drawing up. In the process of the formation of the "explanation" SongShenGao, also for the highest inspection, the ministry of public security and administration of drug safety. 

 

"Explain" SongShenGao three kinds of situations has been clear about the relevant registration fraud charges: 

 

1, drug non-clinical research institutions, drug or medical device clinical test units, contract research organization deliberately provides false non-clinical study, clinical test report, can be convicted and punished by providing false documents sin; 

 

2, for drug registration applicant fraud, providing false non-clinical research or clinical test report and related materials, diddle drug approval documents, can be convicted and punished according to the production, the sale fake sin; 

 

3, drug non-clinical research institutions, drug or medical device clinical test units, contract research organization, with the drug registration applicant provides false non-clinical research or clinical test report and related materials, diddle drug approval documents, at the same time, make crime of providing false documents and production, sales, the crime of counterfeit, convicted and punished for heavier punishment crime. 

 

Supreme law, according to the announcement on April 10, the highest method of voting plenary session after the discussion, has principles through the "explanation". The meeting also decided, according to the meeting to discuss opinions on "explain" SongShenGao modified, and the highest countersign and released in due course. 

 

As above, fake drugs, medical devices registration data will face "the crime of providing false documents" or the production and distribution of counterfeit drugs are "crimes" convicted and punished. And the two charges are included in the "criminal law", the sentencing respectively as follows: 

 

"Criminal law" the two hundred and twenty-ninth [providing false documents; major false certification documents issued by sin 】 for asset appraisal, capital verification, validation, accounting, auditing, legal services, such as responsibility of intermediary organization staff deliberately provides false supporting documents, if the circumstances are serious, shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention and fine. 

 

The provisions of the preceding paragraph, extort property from others property or illegally accept others commits the crime, shall be sentenced to imprisonment of not more than five years but not more than ten years, fine. 

 

The first paragraph of the personnel, serious irresponsible, the certification documents issued by a major untrue, thereby causing serious consequences, shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and concurrently or independently be sentenced to a fine. 

 

"Criminal law" article one hundred and forty-one production, sales, production, sales, fake sin 】 【, fake drugs shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and concurrently be fined; Cause serious harm to human health or there are other serious circumstances, shall be sentenced to fixed-term imprisonment of not more than three years but not more than ten years, fine; Kill or there are other especially serious circumstances, shall be sentenced to fixed-term imprisonment of not less than 10 years, life imprisonment or death, fine or confiscation of property. 

 

Released since 2016, the drug safety administration of the medical equipment quality control standard for clinical trials, and start the authenticity of the medical device clinical trials selectiving examination work. Drug safety administration organized 2 batch of supervision and spot check last year, a total of extract of 20 companies for 20 registration project, checked the involved 40 clinical trials, including eight authenticity problems of application for registration, be made shall not be registered, within one year from the date of shall not be registered again not to accept the decision, there are 122 companies active withdrew 263 for medical device registration. 

 

In addition, last year, the local ShengJu also actively carry out the supervision and spot checks of the second category of medical device in clinical trials. 

 

In the year 2017, YiXie supervision meeting has been clear, but also to strengthen the supervision and administration of medical devices clinical trials and carry out product development, clinical trial samples and authenticity verification of registration data. 

 

As part of the review of medical equipment examination and approval system reform, efforts in the clinical trial supervision and spot checks will be bigger and bigger. 

 

Under this background, the projects of "interpretation", is to deter the industry enterprises and the clinical test units, further clinical data fraud will not only face administrative punishment shall be rejected for registration of drug safety, public security, procuratorate and the court will also timely intervention, to impose criminal liability in jail and fined.