1. Business operating conditions for hospitals

According to Appendix IV of the Investment Law 2020, the business of medical examination and treatment services is a conditional business line.

Pursuant to Point a, Clause 1, Article 41 and Article 42 of the 2009 Law on Medical Examination and Treatment, a hospital is an organizational form of a medical examination and treatment establishment, and must obtain an operating license before operating.

2. Conditions for granting operation licenses to hospitals.

Pursuant to Article 23 of Decree 109/2016/ND-CP, amended and supplemented by Clause 4, Clause 5, Article 11 of Decree 155/2018/ND-CP, to apply for an operating license for hospitals, Law on Science The hospital consulting credit must meet the following facilities conditions:

2.1. About Hospital Size

– A general hospital must have at least 30 beds;

– Specialized hospitals and traditional medicine hospitals must have at least 20 beds; especially for ophthalmology and mental health hospitals, there must be at least 10 beds.

2.2. About facilities

– Having a fixed location (except for mobile medical examination and treatment organizations);

– Ensure the conditions for radiation safety, fire prevention and fighting according to the provisions of law;

– A sterilization area must be arranged to handle reusable medical instruments, unless there is no need to re-sterilize the instruments or there is a contract with another medical facility to sterilize the instruments;

– Arrange the faculties, rooms and corridors to ensure professional activities according to the centralized, continuous and closed model within the hospital’s campus;

– For general and specialized hospitals, the construction floor area must be at least 50m2/bed or more; the width of the front (facade) of the hospital must be at least 10m;

– Have a backup generator;

– Ensure the conditions for medical waste treatment according to the provisions of the law on environment.

2.3. About medical equipment

– Having sufficient medical equipment and instruments suitable to the hospital’s scope of professional activities;

– Having enough means of emergency transport inside and outside the hospital. In case there is no emergency vehicle outside the hospital, a contract must be signed with a medical examination and treatment establishment that has been granted an operating license and has a professional scope of activities in providing emergency services to support transportation. patient.

2.4. About the organization

– Having at least 02 out of 04 internal, external, obstetric and pediatric departments, for a general hospital, or an appropriate clinical department, for a specialized hospital;

– Medical examination department: There is a place to receive patients, an emergency room, a patient stay, a clinic, a minor surgery room (if minor surgery is performed);

– Paraclinical department: having at least one laboratory and one imaging room. Particularly for ophthalmological hospitals, if they do not have an imaging department, they must have a professional support contract with a licensed medical examination and treatment establishment that has an imaging department;

– Faculty of pharmacy;

– Other specialized departments and rooms in the hospital must be suitable to the scale, functions and tasks;

– There are departments and divisions to perform the functions of general planning, personnel organization, quality management, nursing, finance and accounting and other necessary functions.

2.5. About human resources

– The number of full-time (organic) practitioners in each faculty must be at least 50% of the total number of practitioners in the faculty;

– The number of people working, the structure and criteria for professional titles shall comply with the regulations of the Minister of Health;

– Being a full-time practitioner at the hospital;

– The head of the clinical department must satisfy the requirement to be a doctor with a practicing certificate suitable for that specialty; Having had at least 54 months of medical examination and treatment in that specialty. The assignment and appointment of the Dean of the Faculty must be made in writing;

– Heads of specialized departments of the hospital must have a practicing certificate suitable for that specialty and must be a full-time practitioner at the hospital;

– Deans of other faculties who are not subject to the grant of practice certificates must have a university diploma with a major relevant to the assigned work and must be a full-time practitioner at the hospital.

2.6. Scope of professional activities: Performing professional techniques according to the list approved by the Minister of Health.

3. Procedures for applying for an operating license for a hospital

3.1. About profile composition

Pursuant to Clause 1, Article 43 of Decree 109/2016/ND-CP, the components of an application for an operation license for a hospital include:

– An application for an operation license;

– A copy of the business registration certificate;

– The practice certificate of the person in charge of professional and technical expertise of the medical examination and treatment establishment; the person in charge of the specialized section of the medical examination and treatment establishment (Copy);

– Certificate of working process;

– List of registered practitioners at medical examination and treatment establishments;

– Labor contracts and appointment decisions of those operating in the clinic;

– A declaration of physical facilities, medical equipment, organization and personnel of the medical examination and treatment establishment;

– Documents proving that the medical examination and treatment establishment meets the conditions on physical facilities, medical equipment, and personnel organization suitable to the scope of professional activities of one of the forms of organization;

– Charter for organization and operation of a private hospital, Form 03, Appendix XI issued together with Decree 109/2016/ND-CP and the initial operation plan for the hospital;

– A valid copy of the patient transport contract for the hospital that has no means of emergency transport outside the facility;

– The list of professional and technical expertise of the medical examination and treatment establishment proposed on the basis of the list of professional and technical expertise promulgated by the Minister of Health;

– The expected scope of professional activities of the medical examination and treatment establishment;

– Contract for collection of hazardous medical waste;

– Wastewater treatment system for specialized clinics that use water systems during medical examination and treatment.

3.2. About the agency receiving and processing dossiers

Pursuant to Point a, Clause 1, Article 44 of Decree 103/2016/ND-CP, the application for an operation license of a medical examination and treatment establishment being a hospital must be sent to the Ministry of Health.

3.3. About processing time:

Pursuant to Article 44 of Decree 103/2016/ND-CP: The Ministry of Health receives and sends the application receipt form according to the form No. 09, Appendix XI promulgated together with Decree No. 109/2016/ND-CP to proponent.

– Within 60 days from the day on which the complete application is received, the Ministry of Health will consider and appraise the dossier and conduct an appraisal at the establishment to issue an operation license;

– If the application is not valid, within 10 working days from the date on which the application is received, the Ministry of Health must notify the applicant in writing to complete the application. The time limit for processing procedures will be counted from the date of receiving complete and additional dossiers;

– In case the dossier is complete and valid, the Ministry of Health shall set up an appraisal team and conduct the appraisal at the medical examination and treatment establishment to grant an operation license;

– In case of refusal to issue an operation license, the Ministry of Health must reply in writing and state the reasons therefor.

Above is the advice of Khoa Tin Law on: “Sequence and procedures for applying for an operating license for a hospital.”

In case customers have unclear issues or need to discuss further, please call us immediately at 0983.533.005 for a free consultation.

Best regards./.