Procedure for amending the medical examination and treatment license in Vietnam

Procedure for amending the medical examination and treatment license in Vietnam​ (Image from the Internet)

On February 7, 2025, the Ministry of Health issued Decision 443/QD-BYT regarding the announcement of administrative procedures amended in Circular 57/2024/TT-BYT, which stipulates the classification and resolution of administrative procedures in the field of medical examination and treatment under the management authority of the Ministry of Health.

Procedure for amending the medical examination and treatment license in Vietnam

* Case 1: Change of working hours or change of name, address of the medical examination and treatment facility without changing location (Article 65 of Decree 96/2023/ND-CP).

Step 1:

Submit 01 set of documents requesting the change of name, address, working hours of the medical examination and treatment facility as prescribed in Clause 1, Article 64 of Decree 96/2023/ND-CP and pay the fees as prescribed by law for fees and charges to the specific licensing authority as follows:

- Ministry of Health:

+ Administration of Medical Examination and Treatment: for state-owned medical examination and treatment facilities directly under the Ministry of Health and private hospitals except for cases under points b and c of this section;

+ Administration of Traditional Medicine and Pharmacy: for state-owned traditional medicine examination and treatment facilities directly under the Ministry of Health and private traditional medicine hospitals.

+ Administration of Environmental Health: for cases requesting the adjustment of medical examination and treatment operating licenses to perform medical examination and treatment for occupational diseases at state-owned medical examination and treatment facilities directly under the Ministry of Health and private hospitals.

- Department of Health:

+ Medical examination and treatment facilities under the management of the Department of Health (including medical examination and treatment facilities under ministries and sectors), except those directly under the Ministry of Health and those under the management authority of the Ministry of Defense, Ministry of Public Security;

+ Private medical examination and treatment facilities within the management (excluding private hospitals).

Step 2:

Upon receiving the documents, the licensing authority shall issue a receipt for the submission of documents according to Form 02, Appendix I issued together with Decree 96/2023/ND-CP.

Step 3:

- In case there are no requests for modification or supplementation of the dossier, the licensing authority shall adjust the operating license within 20 days from the date recorded on the dossier receipt.

- In case of requests for modification or supplementation of the dossier:

+ Within 05 working days from the date recorded on the dossier receipt, the licensing authority shall send a document to the requesting facility specifying the documents and contents that need modification or supplementation.

Within 06 months from the date the operating license documents have a notification for modification or supplementation, the requesting facility must submit the modified or supplemented documents as required. After this deadline, if the requesting facility has not modified or supplemented, the submitted documents will no longer be valid.

+ After receiving the modified or supplemented documents, the licensing authority shall issue a receipt for the submission of the modified or supplemented documents according to Form 02, Appendix I issued together with Decree No. 96/2023/ND-CP for the modified or supplemented dossier.

++  In  the  case  that  the  modified  or  supplemented  documents  do  not  meet  the  requirements,  repeat  the  process  as  outlined  in  this  section.Within  06  months  from  the  date  the  licensing  authority  issues  a  notification  requesting  modification  or  supplementation,  the  requesting  facility  must  submit  the  modified  or  supplemented  documents  as  required.  After  this  period,  if  the  requesting  facility  has  not  modified  or  supplemented,  or  after  12  months  since  the  initial  submission  of  the  documents,  if  the  supplemented  documents  still  do  not  meet  the  requirements,  the  submitted  dossier  will  be  deemed  invalid.

++  In  case  there  are  no  requests  for  modification,  supplementation  for  the  modified,  or  supplemented  dossiers,  the  licensing  authority  shall  follow  the  procedure  outlined  in  section  1  of  this  step.

Step 4:

Within 05 working days from the date of granting the operating license, the licensing authority shall announce and update on its electronic portal and the Information System on Medical Examination and Treatment Management the information related to the content adjustment.

* Case 2: Change of operational scale, scope of specialized activities, or addition/reduction of the technical list of the medical examination and treatment facility (Article 66 of Decree 96/2023/ND-CP).

Step 1:

Submit 01 set of documents as prescribed in Clause 2, Article 64 of Decree 96/2023/ND-CP and pay the fees as stipulated by the law on fees and charges about:

** Scenario 1:

Adjust the operating license due to changes in the number of beds (the total number of adjusted beds must not exceed 100 beds) from 10% to less than 50% of the total number of beds approved by competent authorities or in cases where the adjustment of bed capacity is less than 10%, but the number of adjusted beds exceeds 30 beds or has completed self-adjustment of bed capacity to below 50% of the total number of beds approved by competent authorities; addition, reduction of the technical list except for special technical lists published by the Minister of Health as regulated in point b, clause 1, Article 145 Decree 96/2023/ND-CP:

- Ministry of Health:

+ Administration of Medical Examination and Treatment: for state-owned medical examination and treatment facilities directly under the Ministry of Health except for cases under point b of this section;

+ Administration of Traditional Medicine and Pharmacy: for state-owned traditional medicine examination and treatment facilities directly under the Ministry of Health.

- Provincial/City Department of Health directly under the central administration:

+ Medical examination and treatment facilities under the management of the Provincial/City Department of Health directly under the central administration (including medical examination and treatment facilities under ministries and sectors), except for those directly under the Ministry of Health and those under the management authority of the Ministry of Defense, Ministry of Public Security;

+ Private medical examination and treatment facilities within the management (including private hospitals).

** Scenario 2. Other cases

- Ministry of Health:

+ Administration of Medical Examination and Treatment: for state-owned medical examination and treatment facilities directly under the Ministry of Health and private hospitals except for cases under points b, c of this section;

+ Administration of Traditional Medicine and Pharmacy: for state-owned traditional medicine examination and treatment facilities directly under the Ministry of Health and private traditional medicine hospitals.

+ Administration of Environmental Health: for cases requesting the adjustment of medical examination and treatment operating licenses to perform medical examination and treatment for occupational diseases at state-owned medical examination and treatment facilities directly under the Ministry of Health and private hospitals.

- Provincial/City Department of Health directly under the central administration:

+ Medical examination and treatment facilities under the management of the Provincial/City Department of Health directly under the central administration (including medical examination and treatment facilities under ministries and sectors), except those directly under the Ministry of Health and those under the management authority of the Ministry of Defense, Ministry of Public Security;

+ Private medical examination and treatment facilities within the management (excluding private hospitals).

Step 2:

Upon receiving the documents, the licensing authority will issue a receipt for the submission of the documents to the requesting facility.

Step 3:

- In case there are requests for modification, supplementation of the dossier, within 07 working days from the date recorded on the dossier receipt, the licensing authority must issue a document sent to the requesting facility, specifying the documents and contents that need modification or supplementation.

Within 06 months from the date the licensing authority issues a notification requesting modification or supplementation, the requesting facility must submit the modified or supplemented documents as required. After this period, if the requesting facility has not modified or supplemented, the submitted dossier will be deemed invalid.

After receiving the modified or supplemented documents, the licensing authority will issue a receipt for the submission of the modified or supplemented documents:

In case the modified or supplemented documents do not meet the requirements, repeat the process as outlined in this section. Within 06 months from the date the licensing authority issues a notification requesting modification or supplementation, the requesting facility must submit the modified or supplemented documents as required. After this period, if the requesting facility has not modified or supplemented, or after 12 months since the initial submission of the documents, if the supplemented documents still do not meet the requirements, the submitted dossier will be deemed invalid.

- If there are no requests for modification, supplementation of the dossier or if the dossier has been completed, the licensing authority:

+ Issue a document permitting the change in the operational scale, scope of specialized activities, or the addition/reduction of the technical list within 20 days from the date recorded on the dossier receipt if it's not required to conduct an actual assessment at the facility.

+ The licensing authority will organize an actual assessment at the requesting facility and create an assessment record within 60 days from the date recorded on the dossier receipt in cases requiring an actual assessment at the facility; the assessment record must clearly state the requirements for modification or supplementation (if any).

Step 4:

After the actual assessment at the facility, the licensing authority is responsible for:

- Issuing a document permitting the change in operational scale, scope of specialized activities, or the addition/reduction of the technical list within 10 working days from the date of issuing the assessment record in cases with no requirements for modification or supplementation;

- Issuing a document notifying the contents that need to be rectified or adjusted within 05 working days from the date of issuing the assessment record in cases where there are requirements for modification or supplementation.

Within 06 months from the date the licensing authority issues a document notifying the contents that need modification or supplementation, if the requesting facility does not complete the modification or supplementation, the submitted dossier will be deemed invalid.

Step 5:

Within 10 working days from the date of receiving the notification document and proof that the requesting facility has completed the modification or supplementation, the licensing authority:

- Issues a document permitting the change in the operational scale, scope of specialized activities, or the addition/reduction of the technical list in cases where it is not necessary to conduct an actual check of the modification or supplementation at the requesting facility;

- Conducts an actual check of the modification or supplementation at the requesting facility in cases where an actual check is necessary:

+ Issues a document permitting the change in the operational scale, scope of specialized activities, or the addition/reduction of the technical list if the requesting facility has completed the modification or supplementation;

+ Issues a document replying and clearly stating the reasons for not allowing the change in operational scale, scope of specialized activities, or the addition/reduction of the technical list if the requesting facility has completed the modification or supplementation.

Step 6:

Within 05 working days from the date of permitting the addition of the technical list, the licensing authority will announce and update on its electronic portal or website, as well as the Information System on Medical Examination and Treatment Management, the information related to the content adjustment.

* Scenario 3: Addition of techniques belonging to the special technical list (Clause 10, Article 66 Decree 96/2023/ND-CP)

Step 1:

The medical examination and treatment facility submits 01 set of documents as prescribed in Clause 2, Article 64 of Decree 96/2023/ND-CP to the Ministry of Health to request consideration for the ability to perform techniques belonging to the special technical list.

Step 2:

Within 05 working days from receipt of the dossier, the Ministry of Health shall assess the ability of the medical examination and treatment facility to perform these special techniques to determine whether a pilot is necessary or whether the facility has the conditions to conduct a pilot.

Step 3:

- In case a pilot implementation of the special techniques is required, follow the process prescribed in Article 97 of Decree 96/2023/ND-CP.

After concluding the pilot implementation of special techniques and having a written report on the pilot results proposing the formal implementation of the special techniques, the following must be conducted:

+ The medical examination and treatment facility submits 01 dossier containing the report on the pilot application of special techniques as prescribed at point c, clause 10, Article 66 of Decree 96/2023/ND-CP and the procedure for performing special techniques proposed by the health examination facility;

+ Within 15 days from the receipt of the complete dossier, the Ministry of Health organizes the assessment of the pilot implementation results and the technical procedures proposed by the medical examination and treatment facility;

+ Within 05 working days from the date of the assessment record of the pilot implementation results and technical procedures, the Ministry of Health decides to allow the medical examination and treatment facility to officially implement the special techniques. If not agreed, a reply with a clear reason must be provided;

+ The medical examination and treatment facility shall perform the steps according to scenario 2 to officially add the special techniques that have been approved for implementation into the scope of specialized activities.

- In case a pilot implementation of the special techniques is not required, the following procedures must be carried out:

+ Within 05 working days, the Ministry of Health issues a decision allowing the medical examination and treatment facility to officially apply the special techniques without needing a pilot. If not agreed, a reply with a clear reason must be provided;

+ The medical examination and treatment facility shall perform the steps according to scenario 2 to officially add the special techniques that have been approved for implementation into the scope of specialized activities.

See detailed contents in Decision 443/QD-BYT effective from March 1, 2025.

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