Medical network at the beginning of June 7, 2016, a national vaccine after major in shandong, national drug safety administration has launched a nationwide circulation of drugs and medical appliance field special big regulation violation behavior. The operation has left the pharmaceutical industry in a critical and critical condition. 

 

Among them, the announcement of the regulation on the circulation of medical devices, announced on June 6, 2016, is exactly one year old. 

 

2016 years have passed, but so far in 2017, most provinces across the country have already started the special field of drug circulation "look back" action, on the one hand is to strengthen regulation results of last year, on the other hand is to cooperate "two votes" and so on the ground and implementation of the New Deal regulation effect. 

 

After the drug, it will be medical devices. And the blue parker instrument notice, so far, in fact there have been some places take the lead in the action, national YiXie circulation regulation "look back" action kicked off, "spark" and quickly start a prairie fire off individually. 

 

The following are some of the areas that have taken the lead and their respective priorities: 

 

One, suining city, sichuan province 

 

On May 27, suining city food and drug administration issued the illegal behavior rectification of suining city medical equipment circulation "look back" work plan ", decided to use 3 months time for centralized control. 

 

Target: two or three kinds of medical device operating enterprises under the jurisdiction. 

 

Regulation time: June 1 - August 31. 

 

In June, we will self-examine and rectify the time for the enterprise. 

 

In July, the drug administration will conduct a comprehensive review of 100 percent coverage of operating enterprises in a controlled and controlled manner. 

 

In August, the drug inspectors will take a "double random" and flight inspection to conduct a sampling of the operating companies. Second class business enterprise face selectiving examination of no less than 10%, three types of business enterprise face selectiving examination of no less than 20%, of which all cold chain management, implant, interventional medical equipment management enterprise has to be spot check. 

 

The focus of the campaign: 10 illegal and illegal activities. 

 

It is illegal for medical devices to be purchased and sold. 

 

Failing to comply with the regulations governing quality management of medical devices; 

 

To take illegal means to obtain the business license (the filing certificate) and to forge, buy and sell, lease and lend the business license (the record certificate); 

 

No key personnel such as quality manager are at work; 

 

Change the premises or the address of the warehouse, enlarge the scope of business or the establishment of a warehouse; 

 

To engage in the operation of a third type of medical device without permission; 

 

The second and third types of medical instruments that have not obtained the registration certificate; 

 

Operating unqualified and expired medical instruments that are outdated, expired and obsolete; 

 

The operating medical instrument specifications and labels are not in conformity with the regulations, and are not required to transport, store, and chain all chains of cold chain management medical instruments; 

 

Failing to establish and implement the quality management system of medical devices, especially in the inspection and sales records system. 

 

Jiuquan city, gansu province 

 

On May 12, jiuquan city food and drug administration issued the jiuquan city medical equipment circulation field illegal conduct during the "look back" work plan ", to launch a three-month centralized control. 

 

Target: all the enterprises in the whole city are engaged in the second and third category of medical devices (including the specialty). 

 

Clean-up time: late may to late August 2017. 

 

May 20 - June 10, preparation and planning stages for the organization. 

 

On June 11, solstice, on July 5, all the business practices since January 1, 2016 will be checked by the self-examination. 

 

July 6 - August 20, the flight inspection overhaul and supervisory inspection phase. Drug safety to track inspection, flight check, cross check way, from the purchase and sale channel and instrument management, the business enterprise to carry out supervision and inspection, rectification and urge enterprises. 

 

August 21 - August 25, the action summary phase. 

 

The focus of the campaign: eight violations of the law. 

 

(1) business enterprises engaged in the wholesale business of medical devices shall be sold to non-qualified business enterprises or units; Medical device business enterprise never has the production of the qualification, the management enterprise buys medical device. 

 

If the operating conditions have changed and are not in conformity with the requirements for the quality management standards of medical devices, they shall not be reformed according to the regulations. To change the premises or the address of the warehouse, enlarge the scope of business or establish the warehouse. 

 

Providing false information or adopting other fraudulent means to obtain the operation license of medical devices; Providing false information in case of filing or filing; Forge, alter, buy and sell, lease, lend "medical device business license" or "medical device business record proof". 

 

4, class iii medical devices business activities without permission, or not after the expiration of the valid period of the medical equipment business license in accordance with the law to deal with the continuation of, continue to engaged in the management of medical equipment. 

 

5, the management of medical device registration certificate of the second, third class medical equipment, especially the agent of imported medical devices within the territory of unlicensed products. 

 

Medical devices that do not conform to compulsory standards or do not conform to the requirements of the registration or registration of the products; The operation of a medical instrument which has no qualified documents, expired, expired or eliminated. 

 

The instructions and labelling of the medical instruments that are operating are not in conformity with the relevant regulations; Not in accordance with the requirements for medical equipment manuals and labels transportation and storage of medical apparatus and instruments, especially not need low temperature, cold storage of medical equipment for the whole chain of cold chain management. 

 

Failing to establish and carry out the examination and inspection records of medical devices in accordance with the regulations; In the second, third class medical equipment wholesale business, and the third class medical appliance retail business enterprise to establish and implement the system of sales record not according to stipulations. 

 

Tianjin binhai new area 

 

On May 25, the binhai new area market regulatory authority to carry out the circulation field of medical equipment management behavior rectification work plan issued by the, during the time period of 2 months. 

 

The target: the jurisdiction of all the second and third types of medical devices operating enterprises. 

 

Regulation time: June 5 solstice August 5. 

 

June 5 - July 31, check for the renovation phase. The bureau shall conduct supervision and inspection of the operating enterprises. 

 

On July 6 - August 1, the district bureau conducted inspections on the special management of various bureaus. 

 

August 1 - August 5, summary stage. 

 

The focus of the crackdown: six major violations of the law. 

 

1. The recordation in the second category of medical equipment management activities, or "the second category of medical device registration certificate" after the expiration of not in accordance with the law to deal with continue, continue to engage in medical equipment management. 

 

2. Without permission, engaging in activities of class iii medical devices to operate or not after the expiration of the valid period of the medical equipment business license in accordance with the law to deal with the continuation of, continue to engaged in the management of medical equipment. 

 

Failing to establish and carry out the examination and inspection records of medical devices in accordance with the regulations; In the second, third class medical equipment wholesale business, and the third class medical appliance retail business enterprise to establish and implement the system of sales record not according to stipulations. 

 

The second and third types of medical devices that have not obtained the registration certificate of instruments. 

 

Engage in the operation of the corneal plastic mirror without permission. 

 

The operation of decorative colored flat contact lenses (lens) without permission. 

 

The city of enshi, hubei province 

 

On April 18, the enshi food drug administration about circulation of drugs and medical appliance field illegal conduct during the "look back" notice of action, regulation time for 3 months. 

 

Target: the whole state pharmaceutical wholesale enterprise, medical device wholesale enterprise. 

 

Enterprises that have been ordered to rectify, revoke the certificate and administrative punishment during the period of special treatment in 2016; Enterprises operating in vitro diagnostic reagents and high-risk medical devices; An enterprise that complains of a report or other source of information indicating a possible security risk; History has a serious record of unpunctuality. 

 

Clean-up time: as of the end of July 2017. 

 

The main priority of the regulation: the first column of the state administration of pharmaceutical and drug administration, (1), (1), (2), (3), (4), (5), and (6); Cooperate with the implementation of the policy of "two votes", the key to crack down on unlicensed operation and attached ticket, zhang ticket goods inconsistent, illegal buying and selling "recycling drugs", statistics and other outstanding problems. 

 

The yanta district of xi 'an, shaanxi province 

 

In march of this year, yanta district pharmaceutical supervision bureau carried out the "look back" of medical device circulation. 

 

Check object: according to the previous year within its jurisdiction the violation behavior, complaints to report, focusing on organization to carry out the aseptic and implantable medical devices, adornment sex is flat color contact lenses, corneal shape mirror, condoms and other products under special supervision and inspection. 

 

Check the key points: whether the products are legally compliant and expired; Whether or not to conduct business activities according to the scope of the business scope of the approved and the record; Whether the purchase and marketing channel is legal and compliance; The enterprise shall establish and carry out the system of inspection and sales discipline of medical devices in accordance with the regulations. 

 

So far, already checked 25 management enterprise, individual companies are found change address, business address and warehouse stock inspection records and other issues has not been established; At the same time, cooperate with the health and family planning commission and the public security bureau to ban the use of the non-chinese label for the use of the unlicensed beauty mechanism of sodium hyalurate.