What is an establishment license of a private clinic? What are the procedures for applying for a license to establish such a private clinic? What are the conditions and required documents for applying?
NPLAW provides complete and accurate information about the procedures and related legal requirements for an establishment license of a private clinic.
I. What is an establishment license of a private clinic?
A private clinic is a healthcare facility established, operated, and managed by an individual or organization in accordance with the law, without including direct State involvement in its operations.
Although current law does not specifically define the term “an establishment license of a private clinic”, it is generally understood as a legal certificate issued by the competent authority to a medical facility, acknowledging that it meets the required standards to operate as a private clinic.
II. Conditions for applying for the establishment license of a private clinic
Private clinics may operate under two forms:
- General clinic
- Specialty clinic
The general conditions for all medical facilities include:
- A decision of establishment from a competent authority for clinics under State’s management; or a business registration certificate or investment license in accordance with the law for other medical examination and treatment facilities.
- An operating license issued by the Minister of Health, Minister of National Defense, or the Director of the Department of Health.
According to Article 43 of the Law on Medical Examination and Treatment 2009, a clinic must demand the following conditions to be issued an operating license:
- Complying with national technical standards issued by the Minister of Health.
- Having sufficient qualified medical practitioners for the scope of services provided.
- Having a person in charge of professional expertise of a medical examination and treatment facility with at least 36 months of medical practice experience.
III. Procedures for applying for the establishment license of a private clinic
1. Required dossier
Based on Clause 1, Article 43 of Decree 109/2016/NĐ-CP, the application dossier includes:
- Application form (Form 01, Appendix XI).
- Certified copy of a decision of establishment, a written document with the name of the medical examination and treatment facility of a competent State agency (for state-owned medical examination and treatment facilities), a business registration certificate (for private medical examination and treatment facilities) , or an investment license (or foreign-invested medical examination and treatment facilities).
- Certified copies of the practicing certificates of the professional expertise and heads of specialty departments.
- List of medical practitioners and other healthcare personnel (including those not required to have practicing certificates).
- Declaration of the facility's infrastructure, equipment, organization, and personnel.
- Documents proving compliance with facility, equipment, and personnel standards for the intended scope of services.
- Charter and operational plan (for hospitals).
- Certified copy of a transportation contract for patients (if the clinic has no ambulance of its own).
- List of proposed professional techniques in accordance with the Ministry of Health’s technical catalog.
- For emergency transport services, certified copy of a specialist support contract with a hospital. For international transfers, certified copy of a transport contract with an airline service provider.
2. Process for the establishment license of a private clinic
According to Decree 109/2016/NĐ-CP, the process consists of four steps:
Step 1: Submitting the application dossier
- Facilities submit the complete dossier to the provincial Department of Health.
Step 2: Receiving of the dossier
- The Department of Health receives and sends the receipt as prescribed to the applicant.
Step 3: Reviewing and assessing
- Within 45 days from the receipt of the complete dossier, the Department of Health reviews it and conducts an assessment.
- If the dossier is incomplete, within 10 working days of receipt, the Department must notify the applicant to amend or supplement it.
- Once the dossier is complete, an assessment team will be formed to appraise the facility. When the conditions are met, the Department shall issue the establishment license.
- If the license is denied, the Department must issue a written explanation.
Step 4: Issuing the establishment license of a private clinic
- Upon approval, the Department of Health issues the establishment license of a private clinic to the clinic.
IV. Common questions regarding the establishment license of a private clinic
1. Authority to issue the license
According to Decree 109/2016/NĐ-CP, the provincial Department of Health is the competent authority to process and issue licenses for private clinics.
2. If clinic signboards don’t include the license number, is it fined?
Under Article 41 of Decree 109/2016/NĐ-CP, after being issued an operating license, medical examination and treatment facilities must have a signboard in accordance with the provisions of law on signboards, must not use the red cross symbol on such a signboard, and must have the following basic information:
- The full name and license number of the facility.
- The address and contact number as listed in the license.
- The operating hours.
Failure to display the license number constitutes a violation under Point a, Clause 1, Article 39 of Decree 117/2020/NĐ-CP (as amended by Decree 124/2021/NĐ-CP) and is subject to a fine of:
- 1,000,000 VND to 3,000,000 VND for individuals.
- Double the amount for organizations.
V. NPLAW’s legal support services for the establishment license of a private clinic
If you need legal assistance with the establishment license of a private clinic, NPLAW offers comprehensive support, including:
- Consulting on relevant legal requirements.
- Drafting complete and accurate application dossier.
- Representing clients in dealings with government authorities until the license is issued.
With a team of experienced lawyers and legal specialists, NPLAW ensures efficient, professional, and reliable services.
