The process of applying for a maternity clinic license in 2024 requires compliance with strict legal procedures and conditions, including medical expertise, facilities, and legal and business management requirements. In the following article, we will provide detailed information on the process of applying for the necessary documents to open a maternity clinic. Please refer to the details below:

1. Legal Regulations

When opening a maternity clinic, private individuals must comply with the following decrees:

• Decree 155/2018/ND-CP amending regulations related to investment and business conditions within the management scope of the Ministry of Health.
• Decree 109/2016/ND-CP regulating the issuance of professional certificates for practitioners and licenses for healthcare facilities.
• Circular 278/2016/TT-BTC regulating the fees, collection, payment, management, and use of fees in the healthcare sector.
• The Law on Examination and Treatment No. 40/2009/QH12.
• Decree 87/2011/ND-CP guiding the Law on Examination and Treatment.

2. Documents Required for Applying for a Maternity Clinic License

To apply for an operational license for a maternity clinic, the process of preparing the necessary documents must comply with the provisions in Clause 1, Article 46 of the Law on Examination and Treatment and Clause 1, Article 43 of Decree 109/2016/ND-CP. The documents required for applying for a maternity clinic license include the following:

a) Application form for an operating license (Form 01), as stipulated in Appendix XI of Decree 109/2016/ND-CP.

b) A valid copy of the decision to establish or a document containing information about the name of the healthcare facility, issued by the competent state authority. Alternatively, a business registration certificate if it is a private facility or an investment certificate if it is a foreign-invested facility.

c) A valid copy of the professional certification of the person responsible for technical expertise and the person in charge of the professional department at the facility.

d) A registration list of practitioners at the facility, including both licensed practitioners and those working in healthcare fields who do not require a license, in accordance with the template in Appendix IV of Decree 109/2016/ND-CP.

đ) A declaration of the facility’s infrastructure, medical equipment, organization, and personnel, using Form 02 in Appendix XI of Decree 109/2016/ND-CP.

e) Documentation proving that the facility meets the requirements for: infrastructure, medical equipment, organization, and personnel suitable for the professional scope of practice, according to the organizational forms specified in Section 1, Chapter III of Decree 109/2016/ND-CP.

g) The organization and operational regulations for hospitals, following the template provided by the Ministry of Health for state hospitals, or Form 03 in Appendix XI of Decree 109/2016/ND-CP for private hospitals, along with the initial operational plan for the hospital.

h) A valid copy of the patient transport contract if the facility does not have emergency transport vehicles.

i) A list of proposed technical specialties based on the list issued by the Ministry of Health.

k) For emergency service facilities providing patient transport, a valid copy of the professional support contract with a hospital. In the case of providing patient transport services abroad, a valid copy of the transport contract with an airline service company is required.

3. Conditions to Prepare Before Applying for a Private Maternity Clinic License

To establish a specialized maternity clinic in 2024, specific conditions must be met when applying for a maternity clinic license as follows:

3.1 Maternity Clinic Infrastructure

According to Article 23a of the law, to applying for a maternity clinic license, healthcare facilities must meet the following conditions:

Facility Infrastructure:

• Must have a fixed location, except for mobile healthcare services.
• Must comply with radiation safety and fire prevention regulations as required by law.
• Must have a designated sterilization area to handle reusable medical instruments, unless the instruments do not require sterilization or there is a contract with another healthcare facility to sterilize the instruments.

Medical Equipment:

• Must have adequate medical equipment suitable for the professional scope of the facility.
• Occupational health clinics must have at least a biochemical testing section.
• Health consultation facilities via information technology or telecommunications are not required to have medical equipment as specified in point (a), but must have sufficient technology and telecommunications equipment suitable for the registered scope of practice.

Specific Equipment to Apply for a Maternity Clinic License:

• Consultation Room: Must ensure a spacious, clean, and airy space to welcome patients. The waiting room must provide enough seating and comfort for patients and their families.
• Basic Medical Equipment: Exam lights, examination tables, chairs for doctors and patients. Essential medical tools include: stethoscopes, blood pressure monitors, thermometers. Office desks and cabinets for medicines and medical instruments.
• Advanced Medical Equipment: Ultrasound machines, ECG machines, X-ray machines (if needed). Specialized medical equipment adjusted for each specific specialty or field.
• Sanitation Materials: Medical gloves, face masks, disinfectant solutions, medical gowns, etc.
• Surgical Equipment: If the clinic offers surgical services, it must be equipped with surgical tools and a properly adjusted operating room to meet safety and hygiene standards.
• Medical Documents & Records: Ensure all legal documentation, medical examination forms, and related paperwork are in place to accurately manage patient information.

3.2 Human Resource Conditions

In addition to the physical infrastructure and equipment, a private maternity clinic must have a quality workforce. The necessary human resources to apply for a maternity clinic license include:

• Specialist Doctors: The team of doctors must be qualified, licensed, and registered with the relevant authorities. They should have the skills and experience in the specialty offered by the clinic.
• Nurses and Medical Staff: Must be assigned to assist doctors in patient care and treatment, ensuring they are trained with basic knowledge and capable of performing medical tasks under the supervision of doctors.
• Administrative Staff: Responsible for managing patient records, scheduling appointments, and performing other office tasks at the clinic.
• Specialists or Support Staff: May be employed to provide quality supplementary services, such as nutrition or psychological counseling, to meet patients’ needs.

4. Scope of Operation for Maternity Clinics

The scope of operation for a specialized obstetrics and gynecology clinic is clearly defined in Article 25, Clause 4 of Circular 41/2011/TT-BYT. The permitted activities include:

1. Providing initial emergency measures for pregnant women in critical conditions.
2. Conducting prenatal check-ups and managing maternal care.
3. Diagnosing and treating common gynecological conditions.
4. Administering vaginal medications and performing IUD insertions.
5. Applying cervical cauterization techniques.
6. Performing colposcopy and conducting biopsies to analyze cancer cells.
7. Performing obstetric ultrasound to assess fetal health and pregnancy status.
8. Performing abortion procedures and medical abortion for pregnancies of 6 weeks or younger (36 to 42 days since the last menstrual period).
9. Other specialized techniques subject to approval by the Director of the provincial Department of Health.

5. Steps to Apply for a Maternity Clinic License

The procedure for obtaining an operating license for a maternity clinic, under the authority of the Department of Health, is as follows:

Step 1: Submit the application for an operating license: The healthcare facility submits the application to the Department of Health.

Step 2: Receive and process the application: The Department of Health receives the application and provides a receipt according to regulations. Within 45 days of receiving the complete application, the Department of Health will review and conduct an inspection at the healthcare facility.

Step 3: Review and process the application:

• If the application is incomplete, the Department of Health will notify the facility to supplement the necessary documents within 10 working days.
• If the application is complete and valid, the Department of Health will inspect the facility and issue the operating license.
• If the operating license is not granted, the Department of Health will issue a written response with the reasons for denial.

Step 4: Issuance of the license: After completing the review process, the Department of Health will issue the operating license to the healthcare facility. The facility can submit the application directly to the Department of Health or send it via mail. The processing time will not exceed 45 days from the date the complete application is received.

This article provides guidance on the necessary procedures and conditions to apply for a maternity clinic license in 2024. We hope that private enterprises will ensure full compliance with current legal regulations. For any inquiries, please contact VIET MY LAW AND ACCOUNTING.

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