In the context of increasingly strong healthcare, opening outpatient clinics not only meets the needs of health care but also brings outstanding convenience to people. In addition, the medical profession is extremely sensitive when it is directly related to human health and life. When a surgical clinic comes into operation, the facility must meet all the conditions prescribed by law. This is a barrier that causes difficulties for many individuals who want to open these clinics. So how to apply license to open a foreign clinic? What are the procedures?. For more detailed information, please read our article below!

1. Legal basis

• Law on medical examination and treatment 2009;
• Decree 109/2016/ND-CP regulating the granting of practice certificates to practitioners and the granting of operating licenses to medical examination and treatment facilities;
• Decree 155/2018/ND-CP amending and supplementing a number of regulations related to investment and business conditions under the state management of the Ministry of Health;
• Circular 41/2015/TT-BYT;

2. Conditions that must be met when applying for a license to open a surgical clinic

According to the provisions of Decree 155/2018/ND-CP, a surgical clinic will be granted an operating license when it meets the conditions listed below:

* Conditions on the infrastructure of the surgical clinic:

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

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

– Must arrange a sterilization area to handle reusable medical equipment, except in cases where the equipment must be re-sterilized or there is a contract with another medical facility to sterilize the instruments.

* Conditions on medical equipment at the surgical clinic:

– Have sufficient medical equipment suitable for the scope of professional activities of the surgical clinic;

– Have anti-shock medicine boxes and enough specialized emergency medicine;

* Conditions for human resources working at the clinic:

– A specialized surgical clinic must have a person responsible for technical expertise and satisfy the following conditions:

+ Have a practice certificate appropriate to the specialty of the surgical clinic;

+ Have at least 36 months of practicing medical examination and treatment after being granted a practice certificate or have at least 54 months of direct participation in medical examination and treatment;

+ The person responsible for professional expertise must be a full-time practitioner at the specialized clinic that is completing paperwork to apply for a clinic operating license. This means that this person will work at the surgical clinic according to the operating hours of the clinic registered with the competent authority.

– Other subjects participating in the process of medical examination and treatment but not required to be granted a practice certificate according to the provisions of the Law on Medical Examination and Treatment are allowed to perform activities as assigned by the person responsible for technical expertise of the medical examination and treatment facility (medical physicist, radiotherapy engineer, speech therapist, psychotherapist and other subjects), the assignment must be consistent with the professional qualifications of that person.

Note: The assignment and appointment of the person responsible for technical expertise of the medical examination and treatment facility must be expressed in a legally valid document.

3. What are the components of the application for a license to open a foreign clinic?

To successfully apply for a license to operate a surgical clinic, the clinic must submit an application to the competent licensing authority. The application is specified in Clause 1, Article 43 of Decree 109/2016/ND-CP, including the following documents:

– Application for a license to operate a surgical clinic;

– Copy of the business registration certificate for private medical examination and treatment facilities or investment certificate for foreign-invested medical examination and treatment facilities;

– Copy of the legally valid practice certificate of the person responsible for technical expertise of the medical examination and treatment facility; the person in charge of the professional department of the medical examination and treatment facility;

– Certificate of work experience participating in medical examination and treatment;

– List of registered practitioners at the medical examination and treatment facility;

– Detailed labor contracts and appointment decisions of those working in that clinic (applicable to clinics affiliated with the company);

– A list of facilities, medical equipment, organization and personnel of the medical examination and treatment facility;

– The expected scope of professional activities of that medical examination and treatment facility;

– Contract for collection of hazardous medical waste;

– Wastewater treatment system for specialized clinics that use water systems during the examination and treatment process for customers;

4. Procedures for applying for a license to open a foreign clinic in 2024

The procedure for applying for a license to open a foreign clinic must go through the following steps:

Step 1: Prepare a set of documents to open a foreign clinic

Businesses wishing to open a Foreign Specialty Clinic need to prepare a set of documents with all the documents listed in part 3.

Step 2: Submit the application to the competent legal authority

Step 3: Check the validity of the documents applying for a license to operate a foreign clinic

When you submit the application to the competent authority. When the documents are valid, the receiving officer will give you a receipt.

In case the application is missing or invalid, the receiving officer is responsible for instructing the person submitting the documents to amend and supplement them in accordance with regulations.

Step 4: Receive the results of the license application according to the appointment schedule

From the date of receiving the documents, within the prescribed time limit, the agency receiving the application will decide to grant a license to operate a Specialized Surgery clinic.

5. What is the penalty for examining and treating patients without a practice certificate?

At Point a, Clause 7, Article 38 of Decree 117/2020/ND-CP, the act of examining and treating patients without a valid practice certificate will be fined from VND 30,000,000 to VND 40,000,000.

In addition to the above acts, the following acts will also be subject to a similar fine of VND 30,000,000 to VND 40,000,000, specifically:

(1) Illegal examination and treatment while the practice certificate is revoked or the practice of examination and treatment is suspended;

(2) Medical examination and treatment beyond the scope of professional activities recorded and registered in the medical examination and treatment practice certificate, except in cases of mandatory emergency and cases of performing additional professional techniques permitted under the provisions of law;

(3) Renting or borrowing another person’s medical examination and treatment practice certificate to practice;

(4) Lending or lending one’s own medical examination and treatment practice certificate to another person for medical examination and treatment;

(5) Failure to promptly provide first aid, emergency aid, or treatment to patients;

(6) Intentionally refusing to examine or treat patients, except in cases where one is entitled to refuse to examine or treat patients under the provisions of law.

In addition to the form of fine, there are additional forms of punishment for the following acts:

– Suspension of the right to use the medical examination and treatment practice certificate for a period of 06 to 09 months for the acts: (5), (6) mentioned above;

– Revoke the right to use the medical practice certificate for a period of 22 to 24 months for the acts: (1), (2), (3), (4) mentioned above.

The issue of “procedures for applying for a license to open a foreign clinic” has been answered by Viet My Law and Accounting above. With the Viet My company system specializing in providing legal services nationwide. We will answer all questions of our customers with a team of experienced and professional lawyers, specialists, and experts. We will help you solve the problem quickly, conveniently, cost-effectively and with the least amount of travel possible.