Tiếng Việt
Medical equipment plays an important role in supporting modern medicine. They are not only effective tools for doctors to diagnose and treat diseases, but also ensure the quality of medical services and patient safety. However, the use of unregistered medical equipment still occurs in some medical facilities and businesses. This is not only a violation of the law but also has many serious consequences for health, professional ethics, as well as legal implications for individuals and organizations involved.
Overview of legal regulations related to medical equipment
Definition of medical device
According to Decree 98/2021/ND-CP, medical equipment is a type of tool, device, software, material or system used individually or in combination for the purpose of:
– Diagnosing, preventing, monitoring, treating or alleviating disease.
– Controlling the body’s condition or supporting health recovery.
Legal requirements for registration
In Vietnam, before being put into use, medical equipment must:
– Be registered for circulation at the Ministry of Health to ensure compliance with safety and quality standards.
– Fully meet the requirements for clinical trials (if necessary), technical standards and production processes.
– Have a valid circulation license, publicly disclose information about the origin, source and manufacturer.
This is to protect the rights and health of users, and to limit the risk of importing and distributing poor quality or counterfeit products.
Regulations on handling violations
Failure to comply with these regulations may be subject to penalties under legal documents such as:
– Decree 117/2020/ND-CP on administrative sanctions for violations in the health sector.
– Penal Code 2015 (amended and supplemented in 2017) for acts causing serious consequences.
Legal consequences of using unregistered medical equipment
Administrative sanctions
According to Decree 117/2020/ND-CP, the act of using or circulating unregistered medical equipment may be subject to:
– Fines depending on the severity of the violation.
– Confiscation of violating medical equipment, forced destruction or re-export (for substandard imported goods).
– Suspension of operations of medical facilities or business enterprises for a period of 3 to 12 months.
This fine not only causes financial damage but also affects the long-term operation of the medical facility.
Criminal prosecution
In case of serious violations, individuals or organizations may be prosecuted. Specifically:
– According to Article 317 of the Penal Code, if using substandard medical equipment causes serious consequences such as harm to health, death or major property damage, the violator may be imprisoned from 1 to 20 years. –
If it is proven that the act of intentionally using counterfeit medical equipment of unknown origin, the sentence may be increased, even life imprisonment.
Civil liability
When the use of unregistered medical equipment results in damage, the violating individual or organization will have to fully compensate the victim. Damages include:
– Medical treatment and rehabilitation costs.
– Loss of income or working capacity of the affected person.
– Compensation for mental damage to the patient or their family.
Consequences on reputation and professional ethics
This violation not only leads to legal sanctions but also seriously affects the reputation of individuals and organizations in the medical field. A medical facility discovered to be using unregistered medical equipment may:
– Lose the trust of patients and the community.
– Face the risk of being boycotted or suspended from operations for a long time.
Negative impacts on public health
Substandard or untested medical equipment can pose major risks to public health, including:
– Diagnostic errors: Results from poor quality equipment can lead to misdiagnosis, seriously affecting treatment methods.
– Direct damage: Some equipment such as X-ray machines, laser machines or surgical instruments, if not up to standard, can cause injury or unwanted side effects. –
Increased risk of cross-infection: Medical equipment that is not hygienic and safe can easily lead to the spread of infectious diseases in the hospital environment.
Causes and gaps to be overcome
Some of the main reasons for the use of unregistered medical equipment include:
– Lack of legal knowledge: Many individuals and organizations are not fully aware of the regulations on registration of medical equipment.
– Economic greed: Some businesses import or produce poor quality medical equipment to reduce costs and increase profits.
– Lax management: Monitoring and handling of violations in this field in some localities are still not strict, creating opportunities for violations.
Solutions to prevent and limit violations
To prevent the use of unregistered medical equipment, it is necessary to synchronously implement the following solutions:
– Strengthen legal dissemination: Provide complete and easy-to-understand information on legal regulations related to medical equipment to medical facilities, businesses and people.
– Improve inspection and supervision capacity: The Ministry of Health and relevant agencies need to regularly inspect and examine medical facilities and businesses, and strictly handle violations.
– Invest in online registration systems: Promote digitalization of the medical equipment registration process to reduce administrative procedures and increase transparency. – Encourage
internal inspection: Medical facilities need to conduct periodic inspections of all equipment in use to ensure compliance with legal regulations.
The role of the community and the patient
Patients and the community also play an important role in monitoring and preventing the use of unregistered medical equipment. They need to:
– Choose a reputable medical facility: Prioritize treatment at licensed hospitals and clinics.
– Find information: Look up and request information about medical equipment before using it, especially for high-cost services.
– Respond promptly: Report to authorities if they discover medical facilities using equipment of unknown origin.
Conclude
Using unregistered medical equipment is not only a violation of the law but also poses a threat to public health, affects the reputation of the medical industry and the sustainable development of the health care system. Therefore, compliance with legal regulations, raising awareness of responsibility and implementing synchronous monitoring measures are necessary factors to ensure safety and effectiveness in medical activities.
For advice on registration services for medical equipment, dietary supplements, cosmetics, and functional foods to ensure procedures comply with current regulations, please contact us at hotline 098.546.1894, email medgatevn@gmail.com or message via fanpage now for support.