Strengthen the supervision of medical devices | 'Experiential' | Sales
Medical Network March 29th: “Experiential” sales of home medical devices means that medical device manufacturers or distributors adopt a free way to provide uncertainties to sales staff who produce or manage medical devices in uncertain places. The short-term behavior of the target. With the attraction of this model, many consumers pay high prices for the products. What are the risks associated with the 'experiential sales' of home medical devices? How to strengthen the supervision of this sales model?
As we all know, medical devices are closely related to human health, and there are strict requirements for engaging in medical device business activities. They must have business premises and storage conditions that are compatible with the scale of operations and business scope, as well as quality management systems that are compatible with the medical devices they operate. Quality management agencies or personnel; engaged in the operation of second and third types of medical devices should also obtain a license qualification.
Due to the high qualification requirements for applying for a medical device operating license, some enterprise Instead, we will launch free medical device promotion activities in townships, rural areas, and communities, or set up a service department with a so-called health consulting seminar to avoid the problem of medical device business licenses. Such services are actually established for the promotion of medical devices. The Ministry has a temporary nature and often 'fights for a change of place', which makes it difficult to supervise the operation of medical devices.
The 'experiential' sales approach is a positive way of selling goods, such as a car test drive, but not all products are applicable. As a medical device directly related to health, it has its scope of application, contraindications, Matters needing attention and other content requiring warnings or prompts, and some also require special storage conditions, methods, which require the operator to have certain expertise in medical devices. However, 'experiential' sales often can not meet these requirements First of all, the recruiters who provide experience activities are generally not subject to rigorous training and assessments. They cannot make professional judgments on the problems that may occur during the medical device experience. They may delay correct treatment or may cause problems due to avoidance of contraindications. Incidents. Secondly, 'experienced' salespeople often exaggerate the effectiveness of the medical devices they provide. Even symptomatic treatment, if over-reliance on the role of home medical devices, can sometimes lead to delays. Third, due to free experience The provider does not qualify as a medical institution and will not follow medical institutions. General provisions should follow when those clinics, such as making medical records, in case of disputes, consumer rights will be difficult.
The author believes that the current law is the 'free experience' in the medical device business process. Regulation Although there is no prohibitive clause, it should strictly abide by relevant regulations and strengthen supervision. The promotion of medical device products should be carried out within the scope of approval. If there is any violation of the medical device advertisement review management regulations, it should be promptly investigated with relevant departments.
For the regulatory measures of 'experiential' home medical device sales, the author has the following suggestions.
First, the regulatory authorities should increase their learning and research on experiential marketing supervision, clarify the direction of supervision, and take measures to control them. They should take the initiative to conduct on-site supervision of individuals and organizations that sell “experiential” home medical devices, and ask operators to have their sites on-site. Post or present a product registration certificate, manual approval document. At the same time, in accordance with the relevant provisions of the medical device operation, the operator is required to establish a ledger, and must not exaggerate the efficacy of publicity, unauthorized reduction of operating conditions and other illegal activities. Sales of unlicensed products and unlicensed sales The behavior of the product must be severely punished according to law. At the same time, the supervisory department should combine market inspections, consumer rights protection, and take the day-to-day supervision mechanism of 'guide-based, penalty-assisted' and the possible violations of 'experience-type' home medical device sales. Learn in advance, intervene in advance, and try to contain illegal activities in the bud.
The second is to increase the publicity of law and promote the laws and regulations such as the “Regulations on the Supervision and Administration of Medical Devices” and the “Administrative Measures on the Supervision and Management of Medical Device Operation” to consumers, especially the middle-aged and elderly consumers. At the same time, consumers should be reminded to purchase medical devices. Check the official product specification, the operator's “Medical Device Business License” and other certification materials, and obtain the traceable sales notes that can reflect the product information, so as to enhance consumers' self-prevention, take initiative to discern their awareness, and guide them to use legal weapons. Maintain its own legitimate rights and interests.
The third is to set clear conditions for the establishment of “experiential” home medical device sales organizations and individuals, set up environmental, personnel qualifications, after-sales services, and law enforcement regulatory responsibilities from the legal and regulatory level, in order to standardize business practices and promote 'experiential ' Home medical instruments Sales model health Development. Explore the development of relevant judicial interpretations and guidance documents on the basis of basic principles of legislation and existing laws and regulations, detail market access, market supervision, and illegal responsibilities, and clarify the powers and responsibilities of supervision and legal responsibility.
