Medical network on April 5 - not long ago, Chinese consumers newspaper news caused concern: throughout the country 30 provinces in 1000 basic medical institutions of the same kind of "import" fully automatic biochemical analyzer, are not registered in accordance with the assembling of fake. 

 

In reality, the cases are was released in early 2016, hubei province food and drug administration in its list of 2015, the provincial food drugs illegal and typical cases, it is also a food and drug administration in hubei province since the establishment of the largest medical instrument fraud case investigation. 

 

But was not revealed, fake goods into the grassroots medical institutions is through formal medical charity charitable organization international action. 

 

Donation of medical equipment, in addition to circumvent bidding, consumables bundling, kickbacks prevalence of these problems, but also can become not legally registered medical devices into the loophole of medical institutions. And when the means of charitable donations can become illegal profit, we can also believe who? 

 

Fujian specific regulation has been registered in accordance with the instruments, donation, transfer of the key 

 

According to the food and drug administration in fujian province, the agency has been carried out in qingming festival on the eve of the deployment of use not in accordance with the registered medical equipment of the rectification work. 

 

Rectification scheme based on fujian province food and drug administration issued by focusing on the object as follows: the province medical institutions at the county level, township hospitals, community health service centers, private medical apparatus and instruments, by contracting units used (or cooperation) of public medical equipment use, such as unit and have been complaints to report problems such as clues unit of medical apparatus and instruments used for inspection. 

 

Check the time as of August 31. And focus on four types of medical equipments, including: 

 

It is a medium and large medical equipment. 

 

Such as type B ultrasound diagnostic instrument, color ultrasonic diagnostic system, medical X-ray equipment such as medical imaging equipment (including medical X-ray tube, pipe component or source component), automatic biochemical analyzer, the immune system such as clinical laboratory analysis instruments, multi-parameter monitor and other medical electronic instrument, endoscopic diagnosis with fibre endoscope medical optical equipment, laser surgery and treatment equipment such as medical laser equipment. 

 

Second, the high value of dental materials. 

 

Such as: dental implant materials, such as customised denture kouqiangke materials. 

 

3 it is implanted materials and intervention equipment such as medical apparatus and instruments. 

 

Such as: breast prosthesis, such as stents implanted materials and artificial organs, PTCA catheter intravascular catheter, etc. 

 

Four is to transfer, donated medical equipment. 

 

Check medical devices use unit transfer between the used medical equipment, medical equipment units to accept medical equipment production and operation enterprises or other ngos, and individual donations, a charity, medical apparatus and instruments. 

 

Not registered in accordance with the instrument to use endowment, fujian four medical institutions was heavy penalties 

 

The big check the key point to the grassroots medical institutions in fujian province, donation, transfer of medical instrument has become a key, and not only enterprise donation to check, ngos and charity donation to also want to check. 

 

Associated with it is that, according to the Chinese consumer newspaper has four basic medical institutions in fujian province because of using the not registered in accordance with the "charm" analyzer, and heavy penalties by the agency. 

 

Fuzhou lienchiang county Huang Qi institutes in the centre of the town, was fined 528000 yuan. Fuzhou changle before camp street community health service center, navigation city street community health service center, the first of institutes of health, was fined 440000. 

 

Drug safety, health, customs, quality inspection... Regulation is unprecedented 

 

Vendor may not sell and medical institutions shall not be used without registration in accordance with the medical equipment is the most basic request, but from the reality, not registered medical devices has never died out in accordance with the law. These products, however, are facing more and more strict, or can be said to be unprecedented regulation. This appeared to be extremely prominent in just the past 2016 year. 

 

In medical equipment production and management regulation has been implemented, on February 1, 2016, drug safety administration issued the quality supervision measures for the administration of medical devices are implemented. The method to make clear a regulation, the use of units shall not purchase, use, transfer without registration or registration of medical device in accordance with the law. Unit using donated medical apparatus and instruments, is no exception. 

 

State development planning commission issued, effective as of November 1, 2016 "medical quality management method" regulation, also of medical institutions and physicians, nurses, use unapproved medical devices, by the health department in accordance with the law in accordance with the rules to deal with. 

 

When medical institutions use this after the last link 'is bedding bag, the corresponding supervision and punishment would be more and more strict, the medicine from around the annual food illegal typical case can also be seen. Even, hebei a maternity and child care because use unregistered import ultrasonic diagnostic instrument, fined nearly 18 million yuan. 

 

In addition, customs and quality inspection in hand. 

 

In April 2016, the shenzhen customs to Shanghai and 9 to customs, uncovered some imported brand dental equipment smuggling case, save many YiXie companies was checked, counterfeit products involved nearly 160 million yuan. This is the first time in shenzhen customs special fight against smuggling of the dental equipment. 

 

In November 2016, the general administration of customs jointly the local public security, unified command 3 11 customs anti-smuggling bureau, such as the first large-scale concentrate on medical equipment (pa/diagnosis instrument, anesthesia machine, etc.) renovation smuggling action, destroy the smuggling gang 19, grasp more than 30 people, involving nearly 380 million yuan. 

 

And, inspection and quarantine departments in north guangdong and jiangsu, are found suspected counterfeit, refurbished ultrasound diagnostic instrument, quality supervision, inspection and quarantine issued for this bulletin, warning the national strengthen inspection. 

 

Look at fujian province food and drug administration to focus on regulation of four class is not registered in accordance with the medical apparatus and instruments, ultrasonic diagnostic instrument, involved in last year's major biochemical analyzer equipment, dental equipment, such as the value of donated medical apparatus and instruments in columns. 

 

Fujian province food and drug administration's official website, with special campaigns to crack down on use not in accordance with the registered medical behavior, medical apparatus and instruments, especially the crackdown on the use of smuggling using second-hand refurbishment, large medical equipment in the behavior, and regulating the behavior of the transfer of medical apparatus and instruments, donation goal. 

 

In 2017, to check not registered medical devices in accordance with the law is not only in fujian province. 

 

2017 national conference on the supervision and administration of medical devices has been coming out of a clear signal that this drug safety focus problems go all out big improvement, focus on the production and sale of counterfeit goods, false advertising, refurbished resale violation behavior, etc. Around the regulators will strengthen collaboration with customs, quality supervision, inspection and other related department, with high pressure situation of the law enforcement case, guarantee the quality and safety of medical equipment. 

 

In places, such as gansu, sichuan and Inner Mongolia provinces is proposed, this year will focus on check unlicensed medical devices into the unit using behavior.