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Cell Therapy

New Technique & Method Permission

dated April 3, 2015, specifying requirements and procedures for granting permission to apply new medicine practices and methods

Key takeaway:

There’s 3 types of New Medical Techque & Method:
Recognized in Vietnam or oversea but has not licensed
Licensed oversea but has not licensed in Vietnam
Licensed in Vietnam but has not licensed in the medical establishment
Process:
Pilot application → Official application
Requirement:
Operation & personnel of healthcare establishment
Facilities
Equipements, devices, medicines, supplies
Technical procedure

Chapter I: GENERAL PROVISIONS

Article 1. Scope of application

This Circular shall specify requirements and procedures for granting permission to apply new medicine practices and methods.
This Circular shall not apply to the following cases:
a) New medicine practice or method of human organ transplantation and body donation. Application of this new medicine practice or method shall be governed by legal regulations on human organ transplantation and body donation;
b) New practice or method of gender reassignment, in-vitro fertilization and surrogacy for the humanitarian purpose. Application of this new medicine practice or method shall be governed by civil, marriage and family laws;
c) If new medicine practices or methods stipulated in Clause 3 Article 69 of the Law on Medical Examination or Treatment have been classified into Class II, III or unknown class by the Ministry of Health, the healthcare establishment shall implement regulations laid down in the Circular No. of the Ministry of Health dated December 11, 2013 on specifying technical or professional lines in the network of healthcare establishments.

Article 2. Determination of new medicine practices and methods

New medicine practices and methods stipulated in Clause 1 Article 69 of the Law on Medical Examination and Treatment shall be specified as follows:

1. Techniques and methods which are studied in Vietnam or overseas, recognized In competent Vietnamese state agencies and applied in Vietnam for the first time

a) Medicine practices or methods have been first researched in Vietnam upon completion of the research activity and are applied after the acceptance test and application for permission have been respectively conducted and filed by the Committee for Evaluation of Ethical Conducts in Biomedical Researches affiliated to the Ministry of Health, or the ministerial-level Science Council, or after the Department of Technology and Training affiliated to the Ministry of Health has granted their Certificate of research result.
b) Medicine practices or methods have been first researched in overseas countries upon completion of the research activity and are applied after the acceptance test in conformity with regulations of the host country have been successfully passed, and the assessment is carried out by the Committee for Evaluation of Ethical Conducts in Biomedical Researches affiliated to the Ministry of Health or the ministerial-level Science Council, and after the Department of Technology and Training affiliated to the Ministry of Health has granted their Certificate of research result.
2. New medicine practices and methods stipulated in Clause 2 Article 69 of the Law on Medical Examination and Treatment shall be specified as follows:

2. Techniques and methods which have been licensed for application by overseas competent state agencies but are applied in Vietnam for the first time

Medicine practices or methods have been licensed by competent regulatory agencies in overseas countries and officially applied at one overseas healthcare establishment at a minimum but are first applied in Vietnam after the professional council established by the Ministry of Health considers and assesses application for granting permission to apply such practices or methods.
3. New medicine practices and methods stipulated in Clause 3 Article 69 of the Law on Medical Examination and Treatment shall be specified as follows:

3. Techniques and methods which have been licensed by competent state agencies and applied in Vietnam, but are applied for the lirst time at a medical examination and treatment establishment

Medicine practices or methods have been classified as minor or major surgical procedures by the Ministry of Health, including special or first class, and are first applied at healthcare establishments.

Article 3. General principles of application of new medicine practice and method

1. Application of new medicine practices and methods shall follow two steps: pilot and official application.
2. As for medicine practices or methods stipulated at Point a Clause 1 Article 2 hereof, the research stage shall be considered as pilot application step.

Chapter II: REQUIREMENTS FOR APPLICATION OF NEW MEDICINE PRACTICES AND METHODS

Article 4. In terms of operation and personnel of healthcare establishments planning to apply new medicine practices or methods

Legal operations
Healthcare establishments planning to apply new medicine practices or methods must obtain the operational permit in accordance with the legislation on medical examination and treatment.
Personnel
a) Provide a sufficient staff of doctors, nurses, midwives, technicians and other healthcare workers to adopt new medicine practices or methods in conformity with the technical process approved in regulations laid down in Article 7 hereof.
b) Those who use new medicine practices or methods must meet the following requirements:
Hold the certificate of medical examination and treatment practice which specifies that the scope of professional practice of the certificate holder is appropriate for application of new medicine practices or methods.
Obtain the certificate of completion of the training in new medicine practices or methods that a healthcare establishment plans to adopt, issued by a qualified training center, or the certificate of completion of technology transfer issued by domestic or overseas healthcare establishments.
Be healthcare workers who are legally working at healthcare establishments.

Article 5. In terms of healthcare facilities

Healthcare establishments must provide facilities which conform to regulations laid down in the Circular No. of the Minister of Health dated November 14, 2011 on providing guidance on offer of the practicing certificate for practitioners and offer of the operational permit for healthcare establishments as well as other necessary conditions in order to meet requirements for application of new medicine practices or methods.

Article 6. In terms of medical equipment, devices, medicines and supplies

Healthcare establishments must provide a sufficient number of medical equipment, tools, medicines and supplies licensed to be traded in Vietnam to meet the requirements for procedure for application of new medicine practices or methods in accordance with the approved medical procedure stipulated in Article 7 hereof.

Article 7. In terms of medical technical procedure

As for application of new medicine practices or methods stipulated in hereof:
Any healthcare establishment adopting new medicine practices or methods is required to establish its medical technical procedure consistent with the framework for writing technical procedures stipulated in the Appendix No. 1 enclosed herewith and approved by the head of such healthcare establishment after conferring with its council on ethical conducts in biomedical researches.
As for application of new medicine practices or methods stipulated in hereof:
Healthcare establishments must follow the technical procedure approved by the Minister of Health. As for any medical technical procedure that has not been approved by the Minister of Health, healthcare establishments are required to establish and approve such technical procedure in accordance with regulations laid down in Clause 1 of this Article.

Chapter III: DOCUMENTATION, PROCEDURE AND AUTHORITY TO GRANT PERMISSION FOR APPLICATION OF NEW MEDICINE PRACTICES OR METHODS

Article 8. Documentation submitted to apply for permission for pilot application of new medicine practices or methods

Written request for pilot application of new medicine practices or methods by adopting the format recommended in the Appendix No. 2 enclosed herewith.
Documents confirming the legitimacy, clinical evidence and efficacy of new medicine practices or methods:
a. As for new medicine practices or methods stipulated at hereof:
Report on the results of clinical trials achieved by applying new medicine practices or methods at overseas healthcare establishments.
Documents confirming completion of evaluation research in the safety and efficacy of new medicine practices or methods, issued by competent regulatory agencies in overseas countries, and written request for permission for application of such practices or methods. These documents must be legalized by consulates as stipulated by Vietnam's laws.
Duplicate appraisal record used as a written request for permission to apply new medicine practices or methods filed by the Committee on Evaluation of Ethical Conducts in Biomedical Researches affiliated to the Ministry of Health or endorsed by the ministerial-level Science Council.
Duplicate certificate of the result of the clinical trial conducted by applying new medicine practices or methods issued by the Department of Technology and Training affiliated to the Ministry of Health.
b. As for new medicine practices or methods stipulated in hereof:
Evaluation report on the safety and efficacy of new medicine practices or methods after overseas healthcare establishments have adopted these practices or methods (including both English and Vietnamese versions).
Authenticated copy of the document confirming that competent regulatory agencies in overseas countries have granted permission to use new medicine practices or methods endorsed by consulates in accordance with Vietnamese legislation.
c. As for new medicine practices or methods stipulated in hereof:
Authenticated copy of the document confirming that competent regulatory agencies have granted permission to Vietnam’s healthcare establishments to apply new medicine practices or methods.
Evaluation report on the safety and efficacy of new medicine practices or methods after Vietnam’s healthcare establishments have adopted these practices or methods.
Plan for application of new medicine practices or methods shall include the main contents such as description of capability of a healthcare establishment applying for permission to adopt such practices or methods with respect to facilities, human force, medical equipment and proposed technical procedure stipulated in Article 4, 5, 6 and 7 hereof; suggested service charge, socio-economic effectiveness and implementation plans.
Authenticated duplicate of the license to practice medicine and authenticated duplicate of the professional certificate of licensed practitioners engaged in the application of new medicine practices or methods. Diplomas, certificates or licenses issued to qualified medical practitioners by overseas organizations must be legalized by consulates in accordance with Vietnam’s legislation.
Authenticated duplicate of the contract for transfer of new medicine practices or methods if such practices or methods are received from other organizations, agencies or individuals.

Article 9. Documentation-receiving agencies

The Medical Examination and Treatment Administration:
a. Receive documentation submitted by healthcare establishments to apply for permission for pilot application of new medicine practices or methods stipulated at Point b hereof and official application of new medicine practices or methods stipulated in Clause 1, 2 Article 2 hereof.
b. Receive documentation submitted by healthcare establishments affiliated to the Ministry of Health, other Ministries or departments and private clinics licensed to provide healthcare services by the Ministry of Health, to apply for permission for pilot application of new medicine practices or methods and official application of new medicine practices or methods stipulated in hereof.
The Department of Health located at centrally-affiliated cities and provinces (hereinafter referred to as the Health Department) shall receive documentation submitted by healthcare establishments that fall within their jurisdiction to apply for permission for pilot application of new medicine practices or methods and official application of new medicine practices or methods stipulated in hereof, exclusive of healthcare establishments stipulated at Point b of this Article.
As for healthcare establishments that fall within the jurisdiction of the Health Department or heath services of Ministries or departments: When submitting their documentation to the Ministry of Health, they must also notify their immediate superior agencies in writing of their submission of documentation to apply for permission for pilot or official application of new medicine practices or methods.

Article 10. Procedure for granting permission for pilot application of new medicine practices or methods

Healthcare establishments are required to submit 01 set of documents under the provisions of Article 8 hereof to the documentation-receiving agencies stipulated in Article 9 hereof.
Documentation submission method: Documentation shall be submitted in person or by post to the documentation-receiving agency.
Within a maximum period of 05 working days from the receipt of such documentation (based on the date specified in the official dispatch-received logbook), the receiving agency is obliged to verify whether it is licit or illicit.
As for illicit documentation, the receiving agency shall send a written notification of continuing to improve such documentation to healthcare establishments applying for permission for pilot application of new medicine practices or methods. The written notification must detail documents that need to be further provided, contents required to be amended or modified.
When receiving a written request for improving submitted documentation, healthcare establishments must make any change or modification in conformity with contents mentioned in this request, and send the changed or modified documentation to the receiving agency. Date of receiving this changed or modified documentation shall be defined on the document-received note or the official dispatch-received logbook of the receiving agency. In case the changed or modified documentation remains unconformable to statutory requirements, healthcare establishments are required to continue to improve their submitted documentation.
Within a permitted period of 07 working days from the date of receiving the licit documentation specified on the documentation-received note or official dispatch received logbook, the receiving agency is obliged to verify this documentation.
When necessary, the head of the receiving agency shall make a decision to confer with experts or establish the Advisory Council to consider the submitted documentation and reach their conclusion on such verification.
Within a permitted period of 03 working days from the receipt of the written documentation verification:
a. As for new medicine practices or methods stipulated at Point b hereof:
The Medical Examination and Treatment Administration shall send a written request to the Minister of Health for a decision to grant permission to healthcare establishments to conduct the pilot application of new medicine practices or methods in which a number of patients or schedule of pilot application of each new medicine practice or method must be clearly identified. In the event of refusing to grant permission to healthcare establishments for the pilot application of new medicine practices or methods, Medical Examination and Treatment Administration shall make a written response and clearly state the reason for such refusal.
b. As for new medicine practices or methods stipulated in hereof:
The Minister of Health or the Director of Health Department shall make a decision to grant permission to healthcare establishments for the pilot application of new medicine practices or methods in which a number of patients participating in the pilot application of each new medicine practice or method must be clearly identified.
In the event of refusing to grant permission to healthcare establishments for the pilot application of new medicine practices or methods, the head of the documentation-receiving agency shall make a written response and clearly state the reason for such refusal.
After completing the pilot application of new medicine practices or methods under the permit decision made by the Minister of Health or the Director of Health Department, healthcare establishments must prepare a written report on the result of such pilot application and request whether the official application is likely to take place.
In case healthcare establishments decide to officially apply new medicine practices or methods, they are required to submit documentation stipulated in Article 11 hereof.

Article 11. Documentation submitted to apply for permission for official application of new medicine practices or methods

After completing the pilot application of new medicine practices or methods, healthcare establishments must prepare a written report on the result of such pilot application of such practices or methods as follows:
Written request for permission for official application of new medicine practices or methods by completing the form stipulated in the Appendix No.3 enclosed herewith.
Report on the result of pilot application of new medicine practices or methods by completing the form stipulated in the Appendix No.4 enclosed herewith.
Technical procedure proposed by healthcare establishments and approved in regulations laid down in Article 7 hereof.

Article 12. Procedure for granting permission for official application of new medicine practices or methods

Healthcare establishments are required to submit 01 set of documents under the provisions of Article 11 hereof to the documentation-receiving agencies stipulated in hereof.
Documentation submission method: Documentation shall be submitted in person or by post to the documentation-receiving agency.
Within a maximum period of 05 working days from the receipt of such documentation (based on the date specified in the official dispatch-received logbook), the receiving agency is obliged to verify whether it is licit or illicit.
As for illicit documentation, the receiving agency shall send a written notification of continuing to improve such documentation to healthcare establishments applying for permission for pilot application of new medicine practices or methods. This written notification must detail documents and contents required to be changed or supplemented.
When receiving a written request for improving submitted documentation, healthcare establishments must make any change or modification in conformity with contents mentioned in this request, and send the changed or modified documentation to the receiving agency. Date of receiving this changed or modified documentation shall be defined on the document-received note or the official dispatch-received logbook of the receiving agency. In case the changed or modified documentation remains unconformable to statutory requirements, healthcare establishments are required to continue to improve their submitted documentation.
Within a permitted period of 15 working days from the date of receiving the licit documentation specified on the documentation-received note or official dispatch received logbook:
a. As for new medicine practices or methods stipulated at Point b hereof: The Director of the Medical Examination and Treatment must grant the decision on establishment of the professional council and verification of the result of pilot application as well as technical procedure proposed by healthcare establishments.
b. As for new medicine practices or methods stipulated in hereof: The Director of the Medical Examination and Treatment or the Director of the Health Department must grant the decision on establishment of the professional council and verification of the result of pilot application as well as technical procedure proposed by healthcare establishments.
The professional council stipulated in Clause 4 of this Article shall be joined by experts in medical administration, clinical or subclinical profession related to new medicine practices or methods. The professional council shall be responsible for verifying the result of pilot application and technical procedure and draw their conclusion in writing.
Within a permitted period of 05 working days from the receipt of the written verification of the professional council, the Minister of Health or the Director of the Health Department shall make a decision to permit healthcare establishments to officially adopt new medicine practices or methods as well as approve the technical procedure. In the event of refusal, they must make a written response and clearly state the reason for such refusal.

Additional:

: Regulations on recognition of clinical research on new techniques and new methods in medical examination and treatment
Decision 2099/QD-BYT in 2017 List of medical examination and treatment technical services classified as equivalent in terms of techniques and implementation costs (Batch 6) issued by the Minister of Health
Decision 7435/QD-BYT in 2018 on the list of medical examination and treatment technical services is classified as equivalent in terms of technical processes and implementation costs according to Circular 39/2018/TT-BYT issued by the Minister of Health

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