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Source:
Article 43, 44 Decree 109/2016/ND-CP
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Article 43. Composition of applications for issuance, reissuance and modification of operation licenses and change of chief physicians of healthcare facilities, declaration of eligibility for conducting check-up

An application for the operation license applicable to healthcare facilities shall comply with regulations in
clause 1 Article 46 of the Law on Medical examination and treatment
⁠
. To be specific:
a. The form No. 01 in Annex XI enclosed with this Decree;
b. A valid copy of the establishment decision or a document containing the name of the healthcare facility issued by a competent authority, applicable to state-owned healthcare facilities, or a certificate of enterprise registration, applicable to private healthcare facilities, or an investment certificate, applicable to foreign-invested healthcare facilities;
c. Valid copies of practice certificates of chief physicians of the healthcare facilities; persons taking charge of professional department of the healthcare facilty;
d. The form in Annex IV enclosed with this Decree;
dd. The form No. 02 in Annex XI enclosed with this Decree;
e. Documents proving that the healthcare facility satisfies the requirements for facilities, medical equipment and organization suitable for the practice scope of any healthcare facility form specified in
section 1 Chapter III
⁠
of this Decree;
g. The Charter of organization and operation using the form regulated by the Minister of Health, applicable to state-owned hospitals, or the Form No. 03 in Annex XI enclosed with this Decree, applicable to private hospitals, and the initial operation plan of the hospital;
h. Valid copies of contracts on patient transport, applicable to hospitals and maternity wards without vehicles for external emergency transportation;
i. A professional and technical list proposed by the healthcare facility on the basis of the professional and technical list issued by the Minister of Health;
k. Regarding emergency transportation service providers: a valid copy of the contract on professional support for the hospital. In case of provision of service of patient transportation abroad, a valid copy of the contract on patient transportation signed with an aviation service company.
Others
2. The application for the operation license applicable to any healthcare facility which changes its organization or is split, amalgamated or mergered shall be conformable to regulations in clause 1 of this Article.
3. An application for the operation license applicable to any healthcare facility which changes its location shall contain:
a) The form No. 04 in Annex XI enclosed with this Decree;
b) Documents specified in clause 1 of this Article (if there is change in the former application).
4. An application for the operation license applicable to any healthcare facility which changes its name shall contain:
a) The form No. 05 in Annex XI enclosed with this Decree;
b) Documents specified in clause 1 of this Article (if there is change in the former application).
5. An application for modification of the operation license applicable to any healthcare facility which changes the scale of patient beds or organizational structure or its practice scope shall be conformable to regulations in clause 3 Article 46 of the Law on Medical examination and treatment, including:
a) The form No. 06 in Annex XI enclosed with this Decree;
b) The form No. 02 in Annex XI enclosed with this Decree.
6. An application for change in chief physicians of a healthcare facility shall include:
a) The form No. 07 in Annex XI enclosed with this Decree;
b) A Decision to dismiss the current chief physician of the facility;
c) A Decision to appoint a new chief physician of the facility;
d) A valid copy of the practice certificate of the person appointed to take charge of professional aspects of the healthcare facility;
dd) The contract or the recruitment decision of the person appointed to take charge of professional aspects of the facility;
e) The form No. 10 in Annex XI enclosed with this Decree;
g) The original of the issued operation license of the healthcare facility.
7. An application for the reissuance of an operation license which is lost or damaged or revoked according to regulations in point a clause 1 Article 48 of the Law on Medical examination and treatment shall contain:
a) The form No. 08 in Annex XI enclosed with this Decree;
b) The original of the damaged license (if any).
8. A declaration of eligibility for conducting check-up:
a) The form No. 01 in Annex X enclosed with this Decree;
b) A valid copy of the issued operation license of the healthcare facility;
c) The form No. 02 in Annex X enclosed with this Decree;
d) The form No. 02 in Annex XI enclosed with this Decree;
dd) A valid copy of the professional and technical list of the healthcare facility;
e) A valid copy of the contract on professional support (if any).

Article 44. Procedures for issuance, reissuance and modification of operation licenses and change of chief physicians of healthcare facilities, declaration of eligibility for conducting check-up

1. The application for issuance, reissuance or modification of an operation license and change of chief physicians of a healthcare facility specified in Article 43 of this Decree shall be made in 01 set and sent to competent authorities, including:
a) The Ministry of Health, applicable to applications sent by healthcare facilities affiliated to the Ministry of Health, private hospitals or hospitals affiliated to other Ministries;
b) Departments of Health, applicable to applications sent by healthcare facilities in local areas, excluding healthcare facilities specified in point a of this clause.
2. Procedures for consideration of the issuance, reissuance or modification of an operation license and change of chief physicians of a healthcare facility:
a) After receiving the application for issuance, reissuance or modification of the operation license, the Ministry of Health or the Department of Health (hereinafter referred to as the receiving authority) shall carry out the following procedures:
- If the application is submitted directly at the receiving authority, the receiving authority shall give the applicant an application receipt note using the form No. 09 in Annex XI enclosed with this Decree;
- If the application is sent by post, within 03 days from the day on which the application is received (pursuant to the coming postmark), the receiving authority shall send the receipt note to the applicant using the form No. 09 in Annex XI enclosed with this Decree.
b) If the application is satisfactory, the receiving authority shall consider the issuance, reissuance or modification of the operation license within 60 days, applicable to hospitals, or 45 days, applicable to other types of healthcare facilities, from the date written on the receipt note. If the application is rejected, a written response containing explanation shall be sent.
c) If the application is not satisfactory, then:
- Within 10 working days from the date written on the receipt note, the receiving authority shall send a written notification to the applicant containing the request for completion. Such notification must specify the contents subject to supplementation and those subject to modification;
- After receiving the request for completion of the application, the chief physicians of the healthcare facility shall comply with the request and send the revised application to the receiving authority;
- After 10 working days from the day on which the revised application is received, the receiving authority which does not request modification or supplementation to the application shall issue/reissue/modify the operation license within the period specified in point b of this clause; otherwise, written response containing explanation shall be sent;
- After 60 days from the day on which the request by the receiving authority is received, if the applicant fails to fulfill the request, the procedures for application shall be re-conducted.
3. The operation license shall be issued by the Minister of Health or the Director of the Department of Health using the form in Annex XII. The number of the operation license shall be pursuant to the table in the form No. 04 in Annex III enclosed with this Decree.
Others
4. Procedures for declaration of eligibility for conducting check-up:
Before conducting the initial check-up, the healthcare facility shall send (directly or by post) a declaration of eligibility for conducting check-up according to regulations in clause 8 Article 43 of this Decree to a medical affair authority. To be specific:
a) For healthcare facilities affiliated to the Ministry of Health: the declaration shall be sent to Medical Service Administration - the Ministry of Health;
b) For healthcare facilities under the management of the Ministry of Public Security: the declaration shall be sent to Health Service Administration - the Ministry of Public Security; for healthcare facilities affiliated to the Ministry of Transport: the declaration shall be sent to Transport Health Service Administration - the Ministry of Transport;
c) For healthcare facilities under the management of Departments of Health (excluding healthcare facilities specified in points a and b of this clause): the declaration shall be sent to the Department of Health of the province where the healthcare facility is headquartered.
5. Processing of declaration of eligibility for conducting check-up:
a) When the declaration of eligibility for conducting check-up has been received, the receiving authority shall send the healthcare facility declaring the eligibility for conducting check-up a receipt note using the form No. 3 in Annex X enclosed within this Decree. If the declaration is not satisfactory as prescribed in clause 8 Article 43, the receiving authority shall send the healthcare facility a written request for completion. When the healthcare facility has completed the declaration, the receiving authority shall send it a receipt note using the form No. 3 in Annex X enclosed with this Decree.
b) If the declaration is satisfactory as prescribed in clause 8 Article 43 and the receiving authority has not sent any request for supplementation or modification, then within 15 working days from the day on which the receipt note is received, the healthcare facility may conduct the check-up according to the declared practice scope.
c) If the healthcare facility which has declared the eligibility for conducting check-up makes change in name of the facility, address, facilities, personnel and practice scope which have been declared, it shall send a written notification to the authority receiving the declaration.
Article 43. Composition of applications for issuance, reissuance and modification of operation licenses and change of chief physicians of healthcare facilities, declaration of eligibility for conducting check-up
Article 44. Procedures for issuance, reissuance and modification of operation licenses and change of chief physicians of healthcare facilities, declaration of eligibility for conducting check-up
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