The Internet era is whizzing, social development is changing with each passing day, and emerging businesses are constantly emerging. Food and drug regulatory authorities should take advantage of this trend, not only to effectively use the advantages of the Internet for efficient supervision, but also to actively respond to new situations and new problems. Specially open this column, welcome the manuscript to talk about the regulatory issues in the Internet age.
At present, China's restrictive regulation on Internet medical device transaction service activities is the "Interim Regulations on the Examination and Approval of Internet Drug Trading Services". For e-commerce activities that provide medical device transaction services through the Internet, there are no strict legal and regulatory restrictions. .
Characteristics determine the difficulty of supervision
The characteristics of medical devices determine the difficulty of safety regulation and the asymmetry of information between operators and consumers. Medical equipment involves many disciplines and majors, and its product performance covers almost all subjects such as clinical medicine, medical examination, biomedicine, bioengineering, applied chemistry, polymer materials, mechanical electronics, and computer mathematics. For such high-end products, industry, industry, research and other industry experts still need to delve deeper, not to mention medical equipment supervisors and ordinary consumers.
Medical devices have both medical and civilian use. The function of the medical device auxiliary treatment is mainly realized by the medical staff of the medical institution through the diagnosis and treatment, and secondly by the patient according to the function of the product itself or with the help of others. The drug regulatory department may include the production, management, and use units involved in medical devices in the scope of supervision, and it is difficult to balance the rehabilitation and auxiliary therapeutic medical devices for patients' self-use.
Online sales of fake medical equipment cases
In addition, some illegal operators use the characteristics of cyberspace freedom, concealment, wide coverage, and difficulty in supervision. Coupled with some commercial websites, they are opportunistic and sell fake and inferior medical equipment in online stores without obtaining relevant qualifications. There is a growing trend in the current sale of counterfeit medical devices online. In recent years, the sale of counterfeit medical devices through the media exposure network is not uncommon, and the infringement of the physical health of consumers who purchase online physiotherapy medical devices is also endless. In addition, since most of the online shopping medical device cases that are complained of are inter-provincial and cross-regional, the regulatory authorities are sometimes inevitably out of reach, and it is difficult to include them in the scope of regulatory inspections, making it difficult for consumers to defend their rights.
At present, how to strengthen the supervision of the medical machinery network trading platform, how to regulate the medical equipment network trading market, and how to ensure the quality and safety of Internet trading medical equipment is still one of the difficult problems that the drug regulatory department needs to solve. The drug regulatory department should improve and explore the regulatory measures for online sales of medical devices, and play a heavy punch.
Strictly qualified business qualification
In addition to strict requirements for the website for selling medical devices, the drug regulatory department must obtain the "Internet Medical Device Trading Service Qualification Certificate" and the "Internet Medical Device Information Service Qualification Certificate". It should also strengthen the network special inspection and prevention and control, and strictly check whether the e-commerce is strictly in accordance with the regulations. The business scope of the record permit is carried out to carry out trading activities, so that the binding terms of the Internet operating medical devices can be further improved and deepened, and the medical device Internet sales audit has strict entry barriers.
Once the website is found to be suspected of violating the law and regulations, the drug supervision department shall order the e-commerce website to immediately delete, isolate, and block the illegal and illegal information, and guarantee the maintenance of the network operation space of honest operation and transaction security.
Timely publicity
The drug supervision department should expand its work ideas, innovate its work mode, and make an eye-catching position on the official portal of the regulatory authorities, publicizing the Internet Medical Device Trading Service Qualification Certificate and Internet Medical Device Information Service Qualification Certificate on the third-party platform of online medical device transactions. Scanned original or certificate number. In addition, companies that engage in Internet medical device transaction services should be strictly required to mark the original or number of the above two certificates in a prominent position on the homepage of the website.
In addition, the regulatory authorities should strictly require the website to establish a link sign. The logo can be directly accessed by the visitor's filing website after clicking by the visitor, and the relevant license approval and filing materials of the medical device operator can be quickly and conveniently queried. At the same time, establish a related data query system, set up a query column, consumers can verify the relevant license information by entering the certificate number. Under the constraints of this publicity system, e-commerce will regulate its business order and build a benign competition mechanism of lawfulness, fairness, fairness and integrity.
Fulfilling warning obligations
The drug supervision department can use SMS, TV, Internet and newspapers to remind consumers of rational consumption, and beware of being deceived and discovering potential safety hazards of medical devices. Unblocking the complaints and reporting channels of 12331, prompting the masses to pay more attention to the safety status of medical devices, making complaints and reports become an important channel for drug supervision departments to obtain clues of cases, effectively combating illegal activities of online sales of medical devices.
Specific warnings include: Before purchasing products through the Internet, you can log in to the data inquiry system of the State Food and Drug Administration website to check whether the medical device registration number has a record, and the product approval scope and function displayed by the product advertisement and data query system. Whether the information is consistent, if the medical device adverse events are found, it should be reported to the regulatory authorities immediately.
At the same time, the regulatory authorities should strengthen the propaganda of laws and regulations, improve the self-discipline of the industry, promote the construction of a credit system, and urge e-commerce enterprises to carry out medical device transaction services in accordance with the law.
Hierarchical management
The drug regulatory department shall make overall plans, integrate resources, and explore methods for hierarchical supervision and management of medical device e-commerce platforms. According to the severity of illegal and illegal clues found in daily supervision, compare illegal plots and motives, consider the degree of illegal profit and social harm, investigate and collect evidence, strictly define the safety level, and establish a medical device e-commerce elimination mechanism.
If the medical device trading network platform sells counterfeit and inferior medical devices in a bad situation, causing serious violations of the legitimate rights and interests of consumers, or serious violations of other laws and regulations, the regulatory authorities must resolutely ban them and include them on the "blacklist". Notify the society.
The supervisory department should not regularly interview the responsible persons of e-commerce who have more problems or are not rectified, urge them to rectify, strictly check and correct themselves, and further establish a system of credit access for medical devices.
In addition, the regulatory authorities should conduct an annual qualification examination for the medical device sales website every year. For websites that refuse to be rectified or rectified several times and still fail to meet the qualifications and upgrade conditions, as well as the products with poor safety rating, they must be retired. , optimize the online trading platform.
Joint defense linkage
The drug supervision department should also cooperate with relevant functional departments such as industrial information, business network management and advertising supervision, public security network security, etc. to construct a medical device online sales record access system, and strengthen supervision of network operation licenses, network operation content, network operation channels, etc. .
For the illegal operation of cross-provincial and inter-regional medical equipment online sales, the local drug regulatory department should issue a letter of inquiry in a timely manner. For violations of laws and regulations on the sale of medical devices in different places, the investigators should strictly investigate and collect and collect the original traceable evidence and transfer it to the drug supervision department of the case. The drug supervision department of the jurisdiction where it is located shall promptly illuminate the sword and investigate and crack down on violations of laws and regulations.
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