In today’s rapidly growing digital era, healthcare services have become one of the essential and ongoing needs of society. This has led to the establishment of an increasing number of specialized clinics to meet the healthcare and treatment needs of the population, especially pediatric clinics for children. Parents are particularly concerned about their children’s health. Furthermore, due to work commitments and time constraints, many parents find it difficult to take their children to public hospitals for check-ups. As a result, pediatric clinics are increasingly being chosen due to their flexibility and quality of service. So, what are the procedures for applying for a pediatric clinic license, and what requirements must be met? Let’s explore the details in the following article.

1. Legal Basis

• The Law on Examination and Treatment 2009.
• Decree No. 109/2016/ND-CP dated July 1, 2016, regulates the issuance of practice certificates for healthcare practitioners and licenses for medical examination and treatment facilities.

2. Conditions to Meet for Opening a Pediatric Clinic

* Facilities:
– There must be a fixed location for medical examination and treatment.
– Ensure compliance with safety regulations for radiation and fire prevention as stipulated by the law.
– There must be a sterilization area for handling reusable medical instruments, unless instruments do not require sterilization or a contract is in place with another healthcare facility for sterilization services.

* Medical Equipment:
– The clinic must be fully equipped with medical devices suitable for its professional scope of activity.
– A shock-resistant medicine box and necessary emergency medication for pediatric care must be available.

* Personnel:
There must be one person responsible for professional and technical expertise, meeting the following requirements:
– The individual must be a doctor with a valid practice certificate in the relevant specialty for the clinic’s scope.
– They must have at least 36 months of experience in medical practice after receiving their practice certificate, or at least 54 months of direct participation in medical examination and treatment. The appointment of the person responsible for professional and technical expertise must be documented in writing.
– The person responsible for professional and technical expertise must be a permanent staff member of the clinic.
– Any other healthcare personnel working in the clinic who are involved in medical examination and treatment must also hold a valid practice certificate and can only perform tasks within their assigned scope. Based on the clinic’s operational scope, qualifications, certifications, and competence, the person responsible for professional expertise must designate healthcare personnel for specific procedures in writing.
– Individuals who participate in medical examination and treatment but do not require a practice certificate according to the Law on Medical Examination and Treatment may perform activities as assigned by the person in charge of professional and technical expertise, with assignments in line with their qualifications.

However, pediatric clinics must also meet the following conditions:

– The clinic must have obtained an operating license as per the legal requirements.

– The clinic must have sufficient departments for clinical examination, subclinical examination, staff, and necessary medical equipment to diagnose and assess health conditions according to health standards and the specific health check certificates issued according to legal guidelines.

3. What Documents Are Required When Applying for a Pediatric Clinic License?

To apply for a pediatric clinic license, the following documents are required:

• Documentation proving that the healthcare facility meets the infrastructure, medical supplies, and personnel requirements in accordance with the activities outlined in the Vietnam Law on Medical Examination and Treatment (Article 1, Chapter III, Decree No. 109/2016/ND-CP).
• An application form for the operation license, as specified in the attached sample of Decree No. 109/2016/ND-CP.
• A business registration certificate, or in the case of a foreign-invested healthcare facility, an investment certificate.
• The professional practice certificates of the person responsible for technical expertise and, if applicable, the head of the specialized department.
• A registration list of healthcare professionals at the pediatric clinic, including those who are required to hold professional practice certificates and those working in healthcare roles who are not required to have a certificate.
• A report on the clinic’s facilities, medical equipment, business operations, and personnel.
• A certificate proving the clinic meets the required standards for facilities, technical specifications, and organizational structure for its specific professional activities.
• A list of technical specialties offered by the clinic, as proposed based on the scientific specialization categories issued by the Minister of Health.

4. Procedure for Applying for a Pediatric Clinic License in 2024

Step 1: Submit Documents

The individual responsible for the healthcare facility must submit the application for an operation license to the Ministry of Health.

Documents can be submitted directly or sent via mail to the Department of Health in the area where the healthcare facility is located:

• In the case of direct submission: The competent authority will accept the application and provide a receipt confirmation to the applicant.
• In the case of mailing: Within 03 working days from the date of receiving the documents, the receiving authority will send a receipt confirmation to the applicant.

Step 2: The Department of Health Receives and Sends Receipt Confirmation

Within 45 days from the date of receiving the complete documents, the Department of Health will review and inspect the application at the facility to issue the operation license:

• If the documents are incomplete: The receiving authority will notify the healthcare facility to complete the necessary paperwork within 10 days from the date on the receipt confirmation.
• If the documents are complete: The receiving authority will issue the operation license within 45 days from the date on the receipt confirmation.

Step 3: Receive the Result

The healthcare facility will receive the result for their application to open a pediatric clinic.

5. What Are the Penalties for Practicing Medicine Without a Valid Medical License?

According to regulations, practicing medicine without a valid medical license will incur fines ranging from 30,000,000 VND to 40,000,000 VND. In addition to practicing without a medical license, the following actions will also be subject to the same penalties:

• Practicing medicine while your license is being revoked or suspended.
• Practicing medicine beyond the scope of your registered medical qualifications.
• Renting or borrowing another person’s medical license to practice.
• Allowing others to use your medical license to practice.
• Failing to provide timely emergency care or treatment to patients.
• Refusing medical treatment to patients, except in cases where the law permits refusal.

6. Tips for Opening a Pediatric Clinic

Registering a pediatric clinic business license can be challenging, not only due to the legal procedures involved but also the need to carefully choose a location and create a business plan for the clinic. With years of experience assisting businesses in obtaining licenses, Viet My Accounting is pleased to share some helpful tips for opening a pediatric clinic:

• Choosing a good location is key to attracting clients. It’s advisable to select a high-traffic area, with good visibility, clean air, parking space, and a spacious environment, which will help your clinic operate efficiently.
• Building a strong brand for a newly established clinic is crucial. In addition to advertising online, it’s essential to build trust with clients to ensure customer retention and attract potential customers over time.
• Having quality equipment and furniture that suits the clinic’s budget and meets industry standards is a must for the clinic’s operation.
• Staffing is also a critical step when opening a pediatric clinic. Proper training, valid professional certificates, and a friendly attitude towards patients can help build goodwill with customers.

This article provides detailed information on “How to Applying for a Pediatric Clinic License According to Legal Regulations.” We hope this article offers a clearer understanding of the process, and Viet My Law and Accounting would be happy to assist you with any future consultation needs related to this process.

LEGAL SERVICES – THE LEADING TAX CONSULTING PROVIDER TODAY

The most reliable Legal and Tax Advisory Services today, highly rated by clients, offering tailored and professional solutions for businesses.

HOTLINE: 0972 39 37 35 (24/7)

REQUEST CONSULTATION REQUEST A QUOTECHAT LIVE WITH US