Procedures for applying for a license to operate a polyclinic

A License to operate a polyclinic is one of the indispensable licenses when a polyclinic operates. Applying for this license will help you operate your clinic transparently and in accordance with the law. Please refer to the following article to understand detailed information about the requirements and licensing application process to ensure the successful and effective operation of a polyclinic.

Organizational forms of medical examination and treatment establishments

Pursuant to Article 39 of Decree 96/2023/ND-CP, current forms of organization of medical examination and treatment facilities include:

1. Medical examination and treatment facilities in the form of hospitals include:

• General Hospital;
• Traditional medicine hospital;
• Dental Hospital;
• Specialized hospital.

2. Medical examination and treatment facilities in the form of clinics include:

• Polyclinic;
• Specialized clinics;
• Interdisciplinary clinic;
• Medical doctor’s clinic;
• Traditional medicine clinic;
• Dental clinic;
• Nutrition clinic;
• General medical clinic.

3. Medical examination and treatment facilities in the form of paraclinical service facilities include:

• Testing facilities;
• Imaging diagnostic facilities;
• Testing and imaging diagnostic facility.

4. Other forms of medical examination and treatment facilities include:

• Medical station;
• Maternity home;
• Traditional medicine diagnostic and treatment room;
• Family medicine medical examination and treatment facility;
• The technical basis for dental restoration;
• Technical facilities for rehabilitation;
• Foundations of clinical psychology;
• Nursing service facilities;
• Midwifery service facilities;
• Palliative care facilities;
• Outpatient emergency facilities;
• The optical facility measures and checks refractive errors;
• Dialysis facilities.

Therefore, each form of organization has its own characteristics in terms of scale, scope of activities and requirements for facilities and personnel. Choosing the appropriate organizational form is the first important step when establishing a medical facility.

Conditions for granting a license to operate a polyclinic

To be granted a license to operate a polyclinic, in addition to meeting the general conditions specified in Article 40 of Decree 96/2023/ND-CP, you must also meet the specific conditions specified in Article 42 of Decree 96/2023/ND-CP. Accordingly:

Regarding scale and organizational structure:

• Have three or more specialties, including at least two of the four specialties of internal medicine, surgery, obstetrics, and pediatrics; have a paraclinical department (testing and diagnostic imaging); There is an emergency room, a minor surgery room (if minor surgery is performed), and a patient storage room;
• In case the polyclinic meets the conditions corresponding to the organizational forms of other medical examination and treatment facilities specified in Article 39 of Decree 96/2023/ND-CP (except for the form of hospital organization) is supplemented with the scope of professional activities corresponding to the form of organization of that medical examination and treatment facility.

About facilities

1. Examination rooms in polyclinics must meet the following area requirements:

• The emergency room has a minimum area of ​​12 m2;
• The patient storage room has a minimum area of ​​15 m2; There are at least 02 beds or more, if there are 03 beds or more, the area must be at least 05 m2 per bed;
• Specialized clinics have a minimum area of ​​10 m2;
• In case techniques and procedures are performed, in addition to the specialized clinic, there must be an additional room to perform techniques and procedures with a minimum area of ​​10 m2; If occupational therapy techniques are performed, the room to perform the techniques and procedures must have a minimum area of ​​20 m2.

2. Have a sterilization area to process reused medical instruments, except in cases where there are no instruments that need to be re-sterilized or there is a contract with another medical examination and treatment facility to sterilize the instruments.
3. In the case of processing and preparing traditional medicine, it must meet the standards for processing and preparing traditional medicine as prescribed by the Minister of Health.
4. There is an anaphylactic emergency box and enough specialized emergency drugs suitable for specialties within the clinic’s scope of professional activities.

Procedure for applying for an operating license

Profile components

According to Article 60 of Decree 96/2023/ND-CP, the application file for a polyclinic operating license includes:

1. Application according to Form 02, Appendix II, Decree 96/2023/ND-CP;
2. A valid copy of the establishment decision or document with the name of the medical examination and treatment facility issued by a competent state agency for state-owned medical examination and treatment establishments or a business registration certificate for with private medical examination and treatment establishments or investment certificates for foreign-invested medical examination and treatment establishments;
3. A valid copy of the practice license and confirmation of practice process according to Form 11 Appendix I of Decree 96/2023/ND-CP of the person in charge of technical expertise of the medical examination and treatment facility;
4. A valid copy of the practice license and confirmation of practice process according to Form 11 Appendix I of Decree 96/2023/ND-CP of the person in charge of the professional department of the medical examination and treatment facility;
5. Declaration of facilities, list of medical equipment, list of personnel meeting the conditions for granting an operating license corresponding to each form of organization according to Form 08 Appendix II of Decree 96/2023/ND-CP and documents proving and confirming those declarations;
6. A list clearly stating the full name and practice license number of each practitioner registered to practice at that facility according to Form 01 Appendix II of Decree 96/2023/ND-CP;
7. Document approved by a competent authority stipulating the functions, tasks, organizational structure of state hospitals or charter of organization and operation for private hospitals according to Form 03 Appendix II Decree 96 /2023/ND-CP;
8. The list of technical expertise of medical examination and treatment facilities is proposed on the basis of the list of technical expertise issued by the Minister of Health.

Steps to apply for a license

The process of applying for a license to operate a polyclinic according to Articles 61 and 67 of Decree 96/2023/ND-CP includes the following main steps:

Step 1: Submit application

The clinic submits 01 application for an operating license to:

• Ministry of Health for polyclinics under its management authority;
• Department of Health of the province/centrally run city where the clinic is located.

Step 2: Process documents and issue operating license

The competent authority will review and process the application and set up an appraisal team at the facility:

Case: The dossier is complete and valid

The Department of Health organizes an appraisal of the operating conditions and technical list implemented at the requested facility and prepares an appraisal record within 60 days from the date recorded on the application receipt slip.

In case there is no request for amendment or supplementation, a new operating license must be issued and a decision to approve the technical list to be implemented at the facility must be issued within 10 working days from the date of issuance of the appraisal record. determination;

• In case there is a request for amendment or supplementation, it must be clearly stated in the content of the appraisal record.
• Within 10 working days from the date of receipt of the written notice and documents proving the completion of remediation and repair of the requesting facility, the operating licensing agency may conduct an inspection. Actual remediation and repair of the proposed facility in case of necessity or implementation of the issuance of an operating license.
• In case of not granting an operating license, there must be a written response clearly stating the reason.

Case: The document is not valid

• The Department of Health must send a document to the requesting facility, which must specifically state the documents and content that need to be amended and supplemented within 10 days from the date recorded on the application receipt slip.
• After amending and supplementing the dossier, the facility requests to send a written notice and documents proving that the amendment and supplement have been completed.

After receiving the amended and supplemented dossier, the operating licensing agency is responsible for implementing the above procedure.

Step 4: Announcement of operating license issuance

Within 05 working days from the date of issuance of the operating license, the operating licensing agency shall publish it on its electronic portal and on the Information System on management of medical examination and treatment activities.

Consulting and supporting procedures for applying for a license to operate a polyclinic in accordance with regulations

Long Phan is proud to provide professional consulting services and support customers in the process of applying for a license to operate a polyclinic. Our services include:

• Consulting on licensing conditions and procedures;
• Assist in preparing and completing documents according to regulations;
• Representatives contact and work with authorities;
• Consulting on facilities and personnel to meet requirements;
• Support in resolving problems that arise during the licensing process.

With extensive experience in the field of medical law, Long Phan provides comprehensive solutions, helping customers save time, costs and quickly obtain a license to operate a polyclinic effectively. Let us accompany you on the path to developing your medical facility. Contact Long Phan immediately via hotline 0906735386 for detailed advice and the most dedicated and professional support.