Can the medical examination and treatment license be adjusted?

Article overview

Adjusting the license for medical examination and treatment activities is an important factor that helps medical facilities improve service quality and meet the increasing medical examination and treatment needs of the people. This adjustment not only creates conditions for medical facilities to expand their scope of operations but also ensures compliance with legal regulations, thereby enhancing their reputation. The article below is a detailed guide on the conditions, procedures, and processes for adjusting medical examination and treatment licenses.

Adjusting the license for medical examination and treatment activities
Adjusting the license for medical examination and treatment activities

Cases of adjusting medical examination and treatment licenses

According to Clause 1, Article 54 of the Law on Medical Examination and Treatment 2023, there are two cases of adjusting operating licenses. Medical facilities need to determine the correct application cases. The adjustment must comply with the provisions of Decree 96/2023/ND-CP.

Case 1: Change basic information

  • Adjust the name of the medical examination and treatment facility
  • Change of address (no change of location)
  • Adjust facility working hours.

Case 2: Changing the scope of expertise

  • Adjust the scale of medical examination and treatment activities
  • Change the scope of professional activities
  • Add or reduce the list of technical expertise.

Conditions for adjusting licenses for medical examination and treatment activities

Article 40 of Decree 96/2023/ND-CP stipulates specific conditions for license adjustment. Medical facilities must fully meet the requirements for human resources and facilities. The appraisal will be based on the following criteria:

Personnel conditions

  • The person in charge of the profession meets the prescribed standards
  • Medical staff have appropriate practice certificates
  • The number of personnel corresponds to the scale of operations.

Facilities conditions

  • Fixed operating location, appropriately designed
  • Medical equipment meets the scope of expertise
  • Ensure safety and environmental hygiene conditions.
Conditions for making adjustments
Conditions for making adjustments

Procedures for adjusting medical examination and treatment operating licenses

Profile components

In case of changing basic information:

  • Application for adjustment (Form 02 Appendix II – Decree 96/2023/ND-CP);
  • Documents proving information changes.

In case of changing the scope of expertise:

  • Application for adjustment (Form 02 Appendix II – Decree 96/2023/ND-CP);
  • Original operating license;
  • A declaration of facilities, medical equipment and personnel records corresponding to the scale or scope of professional activities or technical list expected to change and supporting documents to meet the change.

Legal basis: Article 54 of the Law on Medical Examination and Treatment 2023, Article 64 of Decree 96/2023/ND-CP.

Procedure order

In case of changing basic information:

Step 1: Submit 01 set of documents as prescribed in Clause 1, Article 64 of Decree No. 96/2023/ND-CP.

Step 2: After receiving the application, the operating licensing agency will return the application receipt to the facility according to Form 02 Appendix I issued with Decree No. 96/2023/ND-CP.

Step 3: If there is no request to amend or supplement the dossier, the licensing agency will adjust the operating license within 20 days from the date recorded on the dossier receipt slip according to Clause 2, Article 65 of Decree No. 96/2023/ND-CP.

Step 4: In case there is a request to amend or supplement the dossier, within 05 working days from the date recorded on the dossier receipt slip, the licensing agency will send a document to the requesting establishment, clearly stating the documents and content that need to be amended and supplemented. The facility must submit amended and supplemented documents as requested within 6 months. If the facility does not comply after this deadline, the submitted documents will no longer be valid.

Step 5: After receiving the amended and supplemented dossier, the licensing agency will return the dossier receipt slip according to Form 02 Appendix I issued with Decree No. 96/2023/ND-CP.

  • If the amended or supplemented dossier does not meet the requirements, the licensing agency will notify the facility in writing. Within 6 months, the facility must submit amended and supplemented documents as requested. If not done after this deadline or after 12 months from the date of initial application submission and the additional documents do not meet the requirements, the application will no longer be valid.
  • If there is no request to amend or supplement the amended or supplemented dossier, the licensing agency will comply with the provisions in Clause 3, Article 65 of Decree No. 96/2023/ND-CP.

Step 6: Within 05 working days from the date of issuance of the operating license, the licensing agency will announce and update information related to the adjusted content on the electronic portal and on the information system. information on management of medical examination and treatment activities.

Legal basis: Article 65, Decree No. 96/2023/ND-CP.

In case of changing the scope of expertise:

Step 1: Submit 01 set of documents as prescribed in Clause 2, Article 64 of Decree No. 96/2023/ND-CP.

Step 2: After receiving the application, the licensing agency will issue a receipt to the requesting facility.

Step 3: If there is a request to amend or supplement the dossier, the licensing agency must send a written notification to the facility within 07 working days, clearly stating the documents and content that need to be amended. The facility must submit amended and supplemented documents within 6 months. If not done, the submitted application will no longer be valid.

Step 4: After receiving the amended and supplemented dossier, the licensing agency will issue a receipt for this dossier.

  • If the application does not meet the requirements, the agency must notify the facility in writing. The facility needs to resubmit the application within 6 months. If not done or additional documents do not meet the requirements after 12 months, the documents will no longer be valid.

Step 5: If there is no request for amendment or the dossier is completed according to regulations, the licensing agency will:

  • Issue a document allowing changes in the scale and scope of professional activities or addition or reduction of the technical list within 20 days, if on-site appraisal is not required.
  • Organize appraisal at the facility and make an appraisal record within 60 days, if actual appraisal is needed.

Step 6: After appraisal:

  • If there is no request for amendment, the agency will issue a document authorizing the change within 10 working days.
  • If there is a request for amendment, a written notice of the contents that need to be corrected will be issued within 5 working days. The facility needs to complete modifications within 06 months; Otherwise, the submitted documents will no longer be valid.

Step 7: Within 10 working days from receipt of written notice and documents proving that the amendment has been completed:

  • The agency will issue a document permitting changes if no physical inspection is required.
  • If a physical inspection is needed, the agency will inspect and notify the results in writing. If completed, the agency will authorize the change; If not, there will be a document stating the reason for refusal.

Step 8: Within 05 working days from the date of allowing the addition of the technical list, the licensing agency will publish and update relevant information on the electronic portal and the Information System to manage medical examination and treatment activities.

Legal basis: Article 66 of Decree No. 96/2023/ND-CP.

Regulations on implementation order
Regulations on implementation order

Consulting and support services for applying for adjustment of medical examination and treatment operating license in Long Phan

Long Phan provides consulting and support services including:

  • Support customers in preparing documents to adjust medical examination licenses according to each specific case;
  • Representative submits and explains documents to competent authorities;
  • Support completing the declaration of facilities and personnel records for the conversion;
  • Analyze cases of adjusting specific medical examination licenses to suit the business;
  • Adjust documents as required by competent authorities;
  • Consulting on solutions when risks arise.

If you need support adjusting your medical examination and treatment license, please contact Long Phan immediately via the hotline: 0906735386. With a team of experienced experts, we are committed to providing professional services to assist you in completing procedures quickly and accurately in accordance with current laws.