What are the dossiers and procedures of application for new operation licenses for medical examination and treatment establishments?
- What are the regulations on the operation license for medical examination and treatment establishments?
- What are the dossiers and procedures of application for new operation licenses for medical examination and treatment establishments?
- Is a licensed medical establishment required to operate immediately?
What are the regulations on the operation license for medical examination and treatment establishments?
Pursuant to Article 44 of the 2009 Law on Medical Examination and Treatment of Vietnam stipulating as follows:
“Article 44. Operation licenses for medical examination and treatment establishments
1. An operation license shall be granted once to a medical examination and treatment establishment fully meeting the conditions specified in Article 43 of this Law.
2. An operation license contains the following details:
a/ Name, organizational form and place of operation of the medical examination and treatment establishment;
b/ Scope of professional operations;
c/ Daily working hours.
3. A medical examination and treatment establishment which changes its scale or scope of professional operations shall carry out procedures to modify its operation license. When changing its organizational form, or being divided, consolidated or merged, or changing its place of operation, it shall carry out procedures to apply for a new operation license.
4. A medical examination and treatment establishment whose operation license is lost, damaged or revoked under Point a, Clause 1, Article 48 of this Law may have the license re-granted.
5. The Minister of Health shall promulgate the form of operation license.
6. The Government shall devise a roadmap to grant operation licenses to ensure that by January 01, 2016, all state medical examination and treatment establishments operating at the effective time of this Law possess an operation license.”
And in order to obtain an operation license, a medical examination and treatment establishment must also satisfy the conditions specified in Article 43 of the 2009 Law on Medical Examination and Treatment of Vietnam.
Operation licenses for medical examination and treatment establishments (Image from the Internet)
What are the dossiers and procedures of application for new operation licenses for medical examination and treatment establishments?
Pursuant to Clause 1 Article 46 and Article 47 of the 2009 Law on Medical Examination and Treatment of Vietnam:
“Article 46. Dossiers of application for new, re-granted or modified operation licenses for medical examination and treatment establishments
1. A dossier of application for an operation license comprises:
a/ An application for an operation license;
b/ A copy of the establishment decision issued by a competent state agency, for state medical examination and treatment establishments, or the business registration certificate, for private medical examination and treatment establishments, or the investment certificate, for foreign-invested medical examination and treatment establishments;
c/ Copies of the medical practice certificates of the person responsible for professional and technical operations and the person in charge of the professional section, a list of practitioners with their names, serial numbers of medical practice certificates and scope of professional practice, for hospitals; copies of medical practice certificates of all practitioners, for other medical examination and treatment establishments;
d/ A declaration of physical foundations and medical equipment, a description of the organizational model and personnel records;
e/ Documents proving the medical examination and treatment establishment's satisfaction of the conditions specified in Article 43 of this Law;
f/ For hospitals, apart from the conditions specified at Points a. b. c. d and e of this Clause, the organization and operation charter and the initial operation plan.
2. A dossier of application for a re-granted operation license comprises:
a/ An application for a re-granted operation license;
b/ The original damaged permit (if any).
3. A dossier of application for a modified operation license comprises:
a/ An application for a modified operation license;
b/ A declaration of physical foundations and medical equipment and personnel records corresponding to the scale or scope of professional operations to be adjusted.
Article 47. Procedures to grant, re-grant and modify operation licenses for medical examination and treatment establishments
1. The procedures to grant, re-grant and modify operation licenses for medical examination and treatment establishments are as follows:
a/ Dossiers of application for new, re-granted or modified operation licenses under Article 46 of this Law shall be submitted to the Ministry of Health, the Ministry of National Defense or provincial-level Health Departments;
b/ Within 90 days after receiving a complete dossier, the Minister of Health, or the Minister of National Defense, or the director of a provincial-level Health Department shall grant or modify an operation license. In case of refusal, they shall issue a written reply clearly stating the reason;
c/ Within 30 days after receiving a complete dossier, the Minister of Health, the Minister of National Defense, or the director of a provincial-level Health Department shall re-grant an operation license. In case of refusal, they shall issue a written reply clearly stating the reason.
2. The Minister of Health shall prescribe the organization, persons and procedures for appraisal to grant and modify operation licenses.
3. The Minister of National Defense shall prescribe the organization, persons and procedures for appraisal to grant and modify operation licenses for medical examination and treatment establishments under his/her management.”
So, in order to obtain a license to operate a medical examination and treatment facility, you need to prepare documents and carry out the procedures as prescribed above.
Is a licensed medical establishment required to operate immediately?
Pursuant to Point c, Clause 1, Article 48 of the 2009 Law on Medical Examination and Treatment of Vietnam:
“Article 48. Revocation of operation licenses and suspension from operation of medical examination and treatment establishments
1. An operation license shall be revoked when:
a/ It is granted ultra vires:
b/ The medical examination and treatment establishment fails to meet the conditions specified in Article 43 of this Law;
c/ The medical examination and treatment establishment fails to operate 12 months after obtaining an operation license;
d/ The medical examination and treatment establishment suspends its operation for 12 consecutive months or terminates its operation.
[…]”
Procedures for revocation of operation licenses of medical examination and treatment establishments are specified in Article 5 of Circular 35/2013/TT-BYT.
Thus, at present, the law does not stipulate that after obtaining an operation license, the medical examination and treatment establishment must operate immediately.
But besides that, there is a regulation that after 12 months from the date of being granted the operation license, if the medical examination and treatment establishment fails to operate, the license may be revoked.
Therefore, if you do not want to operate as soon as you are licensed, you can still do it, but you should also pay attention that this period should not exceed 12 months or your license will be revoked.
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