Procedures for applying for a license to operate a specialized clinic

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A license to operate a specialized clinic is a type of license that the state can manage and is proof that the clinic operates legally. Applying for a license will ensure the quality of medical services, protect the rights of patients, and create a healthy competitive environment. Please follow the content of this article, Long Phan will guide you in detail on the steps to apply for a license to operate a specialized clinic according to the latest regulations.

Procedure for applying for a license to operate a specialized clinic
Procedure for applying for a license to operate a specialized clinic

Types of specialized clinics today

Pursuant to Clause 4, Article 22 of Decree 106/2016/ND-CP amending Clause 3, Article 11 of Decree 155/2018/ND-CP, specifying types of specialized clinics. This list includes the following specialist clinics:

  • General internal medicine clinic;
  • Specialty clinics of the internal system: Cardiovascular, respiratory, digestive, pediatric and other specialties of the internal system;
  • Health consultation clinic or health consultation room through information technology and telecommunications means;
  • Surgical specialty clinic;
  • Obstetrics and gynecology clinic;
  • Andrology clinic;
  • Dental – maxillofacial – facial specialist clinic;
  • Ear-nose-throat specialist clinic;
  • Eye specialist clinic;
  • Cosmetic clinic;
  • Specialized rehabilitation clinic;
  • Psychiatric clinic;
  • Oncology clinic;
  • Dermatology clinic;
  • Traditional medicine clinic; Traditional medicine diagnostic and treatment room;
  • Nutrition specialist clinic;
  • Drug addiction treatment support clinic;
  • HIV/AIDS clinic and treatment;
  • Laboratory;
  • Imaging diagnostic clinic, X-ray department;
  • Clinics and treatment of opiate addiction with alternative medicine comply with the provisions of Decree No. 90/2016/ND-CP;
  • Clinic, consultation and preventive treatment;
  • Clinic and treatment of occupational diseases;
  • Other specialized clinics.

Conditions for granting a license to operate a specialized clinic

Pursuant to Article 43 of Decree 96/2023/ND-CP detailing conditions for granting licenses to operate specialized clinics. Accordingly, specialized clinics must meet the general conditions in Article 40 of Decree 96/2023/ND-CP and include the following specific conditions:

  1. Scale and organizational structure of the clinic
  • Have at least one specialty;
  • In case a specialized clinic meets the conditions corresponding to the organizational forms of other medical examination and treatment establishments as prescribed (except for the hospital form), the scope of professional activities corresponding to the regulations will be added in the form of organization of that medical examination and treatment facility, but no more than 03 forms of organization.
  1. Facilities
  • The clinic must have a place to welcome patients, and the examination room must have a minimum area of ​​10 m2;
  • In case techniques and procedures are performed, in addition to the medical examination room, 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;
  • There is a sterilization area to process reusable 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.

There is an anaphylactic emergency box and enough specialized emergency drugs suitable for specialties within the clinic’s scope of professional activities.

Requirements that must be met when applying for a license
Requirements that must be met when applying for a license

Procedure for applying for a license to operate a specialized clinic

Application for licensing

Pursuant to Article 60 of Decree 96/2023/ND-CP. The dossier for licensing 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.
Documents need to be prepared
Documents need to be prepared

Implementation steps

Pursuant to Article 61 and Article 67 of Decree 96/2023/ND-CP. Procedures for applying for a license to operate a specialized clinic are carried out as follows:

Step 1: Submit application

The clinic submits 01 set of application documents for an operating license according to regulations and pays the prescribed fee to the agency competent to issue the operating license. Accordingly, licensing agencies include:

  • Ministry of Health for the case in Clause 1, Article 67 of Decree 96/2023/ND-CP;
  • Department of Health of the province/city for the case in Clause 2, Article 67 of Decree 96/2023/ND-CP;

Step 2: Process documents and issue operating license

After receiving the dossier, the dossier-receiving agency shall issue the requesting facility with a dossier receipt slip according to Form 02, Appendix I, Decree 96/2023/ND-CP.

In case there is no request to amend or supplement documents:

  1. The operating licensing agency shall organize the appraisal of operating conditions and the technical list implemented at the requesting facility and prepare an appraisal record within 60 days from the date recorded on the application receipt note;
  2. 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;
  3. 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.

In case of request to amend or supplement documents:

  • The agency issuing the operating license must send a document to the application base, 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 profile.
  • 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 order as prescribed in Point c, Clause 4, Article 61 of Decree 96/2023/ND-CP.

In-depth consulting and guidance services on applying for a license to operate a specialized clinic in accordance with standards

Long Phan specializes in providing consulting services and support for applying for a license to operate a specialized clinic. With a team of experienced experts, Long Phan is committed to supporting customers throughout the entire process, ensuring compliance with legal regulations and optimizing your time and costs.

Long Phan’s main services include:

  • Consulting on licensing conditions and procedures.
  • Support in preparing and completing documents.
  • Representatives contact authorities.
  • Consulting on explanations and additional documents as required.

A license to operate a specialized clinic opens up opportunities to develop high-quality medical services. You can use reputable and professional consulting units to receive guidance on applying for a license in accordance with the law. If you still have questions related to this license, please contact Long Phan immediately via hotline 0906735386 for detailed advice and support to carry out procedures smoothly and effectively.

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