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    Home > Medical News > Latest Medical News > Liaoning Provincial Drug Administration notice: the treatment of medical device agents.

    Liaoning Provincial Drug Administration notice: the treatment of medical device agents.

    • Last Update: 2020-09-22
    • Source: Internet
    • Author: User
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    Medicine Network September 4th, August 31st, Liaoning Provincial Drug Administration news, the provincial drug regulatory bureau organized to carry out supervision and inspection of imported medical device agents, in accordance with the annual supervision and inspection plan of medical devices, the provincial drug regulatory bureau has recently started the supervision and inspection of imported medical device agents in our province.
    At present, some imported medical device agents have been carried out supervision and inspection, focusing on the approval procedures of agent products, agent operating varieties, information transmission mechanism or system with foreign production enterprises, medical device adverse events collection and reporting, product recall, after-sales service and other aspects of inspection.
    promote enterprises to further implement the duties and obligations stipulated in the administrative regulations, take one example and three, find the weak link of the management system, improve the quality management system.
    next step, the provincial drug regulatory bureau will conduct "double random" inspections of other imported medical device agents in the province, supervise the imported medical device agents to implement the main responsibility in accordance with the law, and ensure the safety and effectiveness of imported medical devices.
    the first half of this year, the General Administration of Market Supervision, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Public Security, the Ministry of Commerce, the General Administration of Customs and the Drug Administration jointly issued a special corrective action plan.
    action for the whole process of rectification, medical equipment is the focus, throughout the production, circulation, consumption, export chain supervision.
    will check the source of production, enterprise qualifications, product standards, product quality.
    , the non-conforming products will be traced back to the whole process, according to law to investigate the responsibility of production operators.
    Check dealers check, reverse arrest enterprises for dealers in addition to their own compliance, another important purpose is to catch enterprises, Guangxi Provincial Drug Administration has previously in accordance with the "Medical Device Supervision and Administration Regulations" "Medical Device Operation Supervision and Management Measures" "Medical Device Operation Quality Management Standards" and other relevant regulations and regulations, formulated "on the promotion of medical device business enterprises storage and distribution services guidance (trial)."
    document points out that for the entrusting party, the emphasis is on checking whether there are any acts such as storing medical equipment outside the address of the licensed repository, over-range operation, over-term operation, "pass-by" and "hanging on".
    inspection should be in the use of the link to spot check the commissioned enterprises operating medical device varieties as a starting point, check to the production enterprise link.
    the illegal acts involving the entrusting party during the inspection, they shall be investigated and dealt with in accordance with the law.
    what is the "ticket", "hanging" behavior? The first is to earn the difference.
    in the field of medical device circulation will often appear, medical device circulation enterprises, based on market competition from lower-priced manufacturers to buy medical devices, and then sold to hospitals at high prices, thereby obtaining high price differentials.
    process, medical device circulation enterprises have repeatedly forged the purchase and sale chain, the purchase of value-added tax invoices to raise the price of drugs, and then obtain cash.
    can make high profits because ticketing is not costly and can be obtained.
    , there are a large number of small circulation enterprises in the market rely on tickets for profit.
    another purpose is to evade regulation.
    Medical device manufacturers, in order to deal with the factory price of medical devices and caused the price department on the high circulation rate of the question, by raising the price of medical devices directly to the distribution and circulation enterprises, so medical device manufacturers bear the legal responsibility for ticketing and tax risks.
    Under the "high open high return" of the direct-operation system, the whole circulation process needs to be realized by opening an invoice from the production enterprise to the circulation enterprise, from the circulation enterprise to the medical and health institution, but the essence of tax evasion by means of passing tickets still exists.
    So hanging and walking tickets can be summarized as: hanging by: refers to medical device operating enterprises for other undocumented units or individuals to provide medical device business sites, qualification certificates and bills and other illegal acts;
    the regulators look into it? Mainly these 9 points for the management of disorderly items, to the bill for example, the regulatory authorities will start to investigate.
    1. Check the wholesale enterprise: rely on the business focus check: whether the medical device wholesale enterprise has the qualification of the rental enterprise or accept the business operation, 2. Check whether the identity of the purchase and sale business personnel is true (wages, social insurance, employment contract); 3. Check the bill record: purchase and sale vouchers and logistics vouchers (such as receipt, acceptance, storage, maintenance, inventory, transportation and other records) are consistent; 4. Check the invoice account number: whether the purchase and sale fund settlement method is in accordance with the provisions, whether the purchase and sale funds and bills flow is consistent, whether it corresponds to the upstream and downstream enterprise value-added tax invoice account number; 5. Check the flow of funds: whether the purchase and sale funds use the enterprise unified account, whether the cash settlement or the personal account number of the clerk settlement; 6. Check the business qualification: whether there are incomplete or untrue information on the purchase and sale of drugs, over-scope operation and other issues.
    7. Check the amount content: check the contents of bills issued or received by passing tickets in accordance with the provisions, whether the bills issued and the actual purchase and sale business amount is consistent; 8. Check sales channels: whether there are no bills to sell medical equipment to primary medical institutions and retail pharmacies; 9. Check bank flow: check whether there are fictitious sales flow, false invoices, the use of false invoices or false receipts through enterprise funds flow accounts and bank statements, etc.
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