Quyết định 36/2006/QĐ-BYT thử lâm sàng trang thiết bị y tế

• Số hiệu: 36/2006/QĐ-BYT
• Loại văn bản: Quyết định
• Nơi ban hành: Bộ Y tế
• Người ký: Lê Ngọc Trọng
• Ngày ban hành: 14/11/2006

BỘ Y TẾ	CỘNG HOÀ XÃ HỘI CHỦ NGHĨA VIỆT NAM Độc lập - Tự do - Hạnh phúc
Số: 36/2006/QĐ-BYT	Hà Nội, ngày 14 tháng 11 năm 2006

QUYẾT ĐỊNH

VỀ VIỆC BAN HÀNH "QUY ĐỊNH VỀ THỬ LÂM SÀNG TRANG THIẾT BỊ Y TẾ"

BỘ TRƯỞNG BỘ Y TẾ

Căn cứ Nghị định số 49/2003/NĐ-CP ngày 15/5/2003 của Chính phủ quy định về chức năng, nhiệm vụ, quyền hạn và cơ cấu tổ chức của Bộ Y Tế;
Căn cứ Nghị định số 12/2006/NĐ-CP ngày 23/01/2006 của Thủ tướng Chính phủ quy định chi tiết thi hành Luật Thương mại về hoạt động mua bán hàng hoá quốc tế và các hoạt động đại lý mua, bán, gia công và quá cảnh hàng hoá với nước ngoài;
Theo đề nghị của các Ông, Bà Vụ trưởng Vụ Khoa học và Đào tạo, Vụ trưởng Vụ Trang thiết bị và Công trình Y tế, Vụ trưởng Vụ Pháp chế,

QUYẾT ĐỊNH

Điều 1.Ban hành kèm theo Quyết định này "Quy định về thử lâm sàng trang thiết bị y tế".

Điều 2.Quyết định này có hiệu lực sau 15 ngày, kể từ ngày đăng công báo.

Điều 3.Các Ông, Bà: Chánh Văn phòng, Chánh Thanh tra, Vụ trưởng các Vụ thuộc Bộ Y tế, Cục trưởng Cục Quản lý Dược Việt Nam, Cục trưởng Cục An toàn Vệ sinh thực phẩm, Cục trưởng Cục Y tế dự phòng, Cục trưởng Cục Phòng chống HIV/AIDS, Giám đốc Sở Y tế các tỉnh, thành phố trực thuộc trung ương, Thủ trưởng Y tế ngành và Thủ trưởng các đơn vị trực thuộc Bộ Y tế chịu trách nhiệm thi hành Quyết định này./.

KT. BỘ TRƯỞNG THỨ TRƯỞNG Lê Ngọc Trọng

FILE ĐƯỢC ĐÍNH KÈM THEO VĂN BẢN

Tiếng Anh (English)

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness --------------
No. 36/2006/QD-BYT	Hanoi, November 14, 2006

DECISION

ON PROMULGATION OF "THE REGULATION ON CLINICAL TRIALS FOR MEDICAL EQUIPMENT”

MINISTER OF HEALTH

Pursuant to the Government’s Decree No. 49/2003/ND-CP dated May15, 2003 on functions, missions, authority and organizational structure of the Ministry of Health;

Pursuant to the Prime Minister’s Decree No. 12/2006/ND-CP dated January 23, 2006 on details for implementation of the Commercial Law with regard to international trading of goods and agencies' trading, processing and transit of goods for foreign partners;

At the requests of the Head of the Department of Science and Training, Head of the Department of Medical Equipment and Works and Head of the Department of Legal affairs.

DECISION:

Article 1. This Decision is enclosed with "the Regulation on clinical trials for medical equipment".

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Article 3. Chief of Office, Chief of Inspectorate, Heads of departments under Ministry of Health, Head of Drug Administration of Vietnam, Head of Food Hygiene and Safety Administration, Head of General Department of Preventive Medicine, Head of Vietnam Administration of HIV/AIDS Control, Directors of provincial Departments of Health, Heads of medical agencies and other units under Ministry of Health shall be responsible for implementing this Decision. /.

FOR MINISTER
DEPUTY MINISTER




Le Ngoc Trong

CLINICAL TRIALS FOR MEDICAL EQUIPMENT
(Enclosed to the Decision No. 36/2006/QD-BYT dated November 14, 2006 by Minister of Health)

Chapter I

GENERAL

Article 1. Scope

This regulation defines principles, requirements, applications, procedures, authority to verify plans, research organization, quality inspection, finances, acceptance formalities, announcement of results of clinical trials for medical equipment, rights and responsibilities of entities in possession of equipments, organizers of trials and participants in clinical trials for equipment.

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This regulation applies to:

1. Entities in possession of medical equipment to be tested, organizers of trials and participants in clinical trials for medical equipment in accordance with this Regulation.

2. Medical equipment to undergo clinical trials consists of:

a) Medical equipment that newly derives from domestic studies and is subjected by competent state management authorities to clinical trials.

b) Medical equipment initially imported into Vietnam and subjected by competent state management authorities to clinical trials.

Article 3. Terminology

In this regulation, the following words and phrases are construed as follows:

1. Medical equipment includes:

a) Machines, devices, system of devices, materials and apparatus for prevention, diagnosis, treatment of diseases and rehabilitation for human beings.

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2. Clinical trials for medical equipment (referred to as trials) mean the process of research and assessment of safety and efficiency of medical equipment on human.

3. Preclinical trials for medical equipment refer to studies done on experimental animals or biological fluids to evaluate biological interaction, toxicity and effects of medical equipment.

4. Entities in possession of medical equipment to undergo clinical trials mean organizations and individuals that study, produce, import, export or distribute medical equipment.

5. Organizers of clinical trials for medical equipment refer to health facilities that conduct scientific research and meet infrastructural requirements for performance of clinical trials for medical equipment in conformity to assessments and approvals by the Ministry of Health.

6. Participants in clinical trials are patients or healthy volunteers who participate in trials.

Article 4. Principles of clinical trials for medical equipment

1. Clinical trials for medical equipment shall adhere to procedures for management of science, technology and ethics in medical and biological research.

2. Participants in clinical trials shall be selected in safe and confident manners according to ethical principles in medical and biological research.

3. Data and findings from clinical trials shall only be published after assessed and approved by competent government authorities.

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REQUIREMENTS FOR CLINICAL TRIALS FOR MEDICAL EQUIPMENT

Article 5. Requirements for medical equipment

1. Equipment produced domestically:

a) Have passed research on design, engineering, technical features and production technology.

b) Have passed inspections and assessments of technical specifications of the equipment for guaranteed quality and safety.

c) Have passed evaluation tests regarding biological interaction.

Results of such processes must be verified, evaluated and endorsed, by at least a ministerial-level Council of Science and Technology, for subsequent clinical trials.

2. Medical equipment required to undergo clinical trials:

Pursuant to legal regulations on importation of medical equipment and to requests by state management authorities.

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1. Have scientific research function, be independent and have no economic connection with entities in possession of medical equipment to undergo clinical trials.

2. Have sufficient human resources to perform research:

a) Principal investigator of a clinical trial for medical equipment must possess adequate qualities and expertise concerning the research field, experience in clinical practice and use of medical equipment, solid knowledge of regulations on management of science, technology and ethics in research, and abilities to undertake the research and trial.

b) Researchers possess adequate qualities and expertise pertinent to requirements of the research and have undergone relevant training in knowledge and skills related to the research.

3. Have infrastructures and medical equipment adequately qualified for the research to proceed in scientific, safe and efficient manners for good clinical practice.

4. Undergo assessments by Ministry of Health and obtain its approval for trials.

Chapter III

APPLICATION, PROCEDURE AND APPROVAL OF CLINICAL TRIALS FOR MEDICAL EQUIPMENT

Article 7. Application for clinical trials for medical equipment

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1. The written request by the entity in possession of the equipment for clinical trial for medical equipment (Appendix 1);

2. The filled-out form of application by the clinical trial organizer for clinical trial for medical equipment (Appendix 2);

3. The plan of clinical trial for medical equipment (Appendix 3);

4. The scientific resume of the principal investigator and lead researcher;

5. The written undertaking of research ethics;

6. The written request for evaluation of research ethics;

7. Technical documents of the medical device to undergo clinical trial:

a) Technical standards and quality inspection papers from competent authorities;

b) The description of technical features and guidelines for installation and use;

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d) For products studied and made domestically:

- Factory certificate

- Written record of verification and evaluation by the competent Scientific Council of technical features, product quality and preclinical trial result. The conclusion of such Council must specify the quality and safety of the product and endorse the clinical trial on human.

dd) For medical equipment imported:

- Certificate of quality (ISO, FDA, EC or equivalent);

- License for sale in the country of production (original or valid copy);

- Information on safety and performance in the last 2 years from the issue date of the request.

 - Other details as requested by competent statement management authorities.

Such papers must be enclosed with a translation and a notarized and consular legalized copy.

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9. The written record of the approval by the Science Council at the grassroot level of the scientific and ethical aspects of the research.

The application shall be presented in Vietnamese and in 2 original sets.

Article 8. Application processing

1. Department of Science and Training shall take in applications and assess conditions for clinical trials and legality of such applications.

2. If conditions and the application for clinical trial abide by Article 5, 6, 7 of this Regulation, the Head of the Department of Science and Training shall report to the Minister of Health after 15 working days for the latter to establish a Council of Science and Technology under Ministry of Health, which reviews and verifies the research proposal, and to form a Council of Ethics in medical and biological research, which reviews ethical aspect of the research, according to current regulations. Subsequently, such councils shall provide their meeting records to the Minister for approval of the research.

Article 9. Approval of research title

Minister of Health shall consider and decide to approve a clinical trial upon satisfaction of these requirements:

1. The application for clinical trial for medical equipment suffices according to Article 7 of this Regulation.

2. Council of Science and Technology under Ministry of Health has assessed and unanimously endorsed the research proposal and the principal investigator and lead organization have adopted revisions as per the Council's recommendations (if any).

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Chapter IV

PERFORMANCE OF CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Article 10. Design of research

1. A clinical trial for medical equipment shall be open, with or without comparators. Council of Science and Technology shall provide specific counsels to each study with regard to sampling size, research time, crucial trial phases and assessment of such phases.

2. When performing the research at various facilities, the organizer of clinical trials for medical equipment shall form a general management team composed of the principal investigator, heads of branch subjects and representatives of lead organizations in order to reach unanimity in goals, research details, assessment indices, plans and schedule.

Article 11. Collection of data

1. The process of a clinical trial must be recorded into sheets of clinical trial for medical equipment (Appendix 5). Such sheets shall record every information gained during the trial and be used for supervision, acceptance and evaluation of the research. The sheets are deemed as original papers that are retained in long term.

2. Originals of relevant materials necessary for clinical assessment must be photocopied precisely, traced and stored as per regulations. Such materials include test reports, radiographs, medical record and other relevant papers.

Article 12. Storage of data and research documents

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2. The principal investigator shall be held liable fully for the retention of the research's documents and be responsible for presenting the documents requested for purpose of inspection.

Article 13. Reporting

Reports must indicate methodology, clinical trial progress, medical equipment's operations, data analysis and assessment of findings. Reports must provide accurate, honest and unbiased conclusions. Content of reports must be pertinent to the goals and content of the research as shown in the proposal approved.

The principal investigator shall be held liable for the scientific nature and accuracy of data, conclusions, remarks, confidentiality and other matters of reports.

QUALITY INSPECTION AND HANDLING OF ANOMALIES DURING THE TRIAL

Article 14. Inspection and supervision of quality

1. Quality is inspected and supervised to sustain the rights, interests and health of participants in clinical trials and to assure that the research is recorded in adequate, precise and timely manners in conformity to the research proposal approved.

2. Minister of Health shall supervise trials and conduct regular and ad-hoc inspections on case basis.

3. Entities in possession of clinically tested equipment can assign individuals to supervise the research and to assume liabilities to the laws for such entities' activities.

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Article 15. Credibility of data

In each phase of the research, all (original) clinical data and test figures gained shall be examined when recorded. Conclusions in a research finding report must be deduced from original data.

Councils for acceptance at different echelons may summon specialists to supervise findings, examine original data and assess the research's products, if deemed necessary/

Article 16. Handling of anomalies

Anomalies during the research shall be handled as follows:

1. If complications occur and menace the life of clinical trial participants, the principal investigator and organizer of the clinical trial shall terminate the process immediately, give emergency aids, cope with problems, make written records and report to competent state management authorities in an urgent manner.

2. If a test damages the health of clinical trial participants, the principal investigators shall halt the research to have them treated and monitored. Subsequently, the clinical trial shall be reviewed to proceed or to discontinue.

3. If anomalies are expected and settled effectively, the clinical trial shall continue.

Chapter VI

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Article 17. Rights of entities in possession of medical equipment clinically tried

1. Organizations and individuals in possession of medical equipment clinically tried can select organizations that have adequate facilities and specialist personnel from the Ministry of Health's list to conduct the clinical trial for medical equipment.

2. Organizations and individuals in possession of medical equipment clinically tried can use the copyright of the findings of the clinical trial. They shall be entitled to request confidentiality of their products and relevant research findings.

Article 18. Responsibilities of entities in possession of medical equipment clinically tried

1. Be held liable to the laws for the quality and safety of the medical device tested.

2. Provide adequate medical equipment to be tested and relevant technical documents as requested by the organizer (instructions for installation and operation of medical equipment, issue-handling procedures, requirements for maintenance and use, reuse, safety check before and during use).

3. Fund the clinical trial for medical equipment as per the proposal approved by the Ministry of Health (and for any damages) according to the contract between the entity in possession of the medical device clinically tried and the organizer of such clinical trial.

4. Be responsible for handling consequences and making amends to clinical trial participants if menaces ensue due to the use of the medical device tested according to the laws.

5. Cooperate with principal investigators and organizers of clinical trials to supervise the clinical trial for medical equipment in a strict manner to maintain contents and schedule as shown in the proposal approved.

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1. An organizer of a clinical trial for medical equipment shall have all rights and interests similar to those gained upon its leading of other studies in science and technology.

2. A principal investigator in a clinical trial for medical equipment shall have all rights similar to those in other studies in science and technology. He can design the research, select collaborators, organize relevant units during the research and allocate research funds in active and effective manner as per regulations.

Article 20. Responsibilities of the organizer of clinical trial for medical equipment and principal investigator

1. An organizer of a clinical trial for medical equipment shall be responsible for:

a) Instructing the principal investigator and research team to conduct tests as per the proposal and plan of research, safeguarding the health of participants, adopting emergency measures to overcome consequences of risks and providing guidelines for spending as per regulations;

b) Supervising clinical trials, managing the medical device received for tests, securing information on research findings for entities in possession of medical equipment clinically tried.

c) Signing and ending clinical trial contracts with entities in possession of equipment to be tested;

d) Organizing research acceptance at grassroot level and reporting research findings for ministerial-level acceptance as per regulations.

2. A principal investigator shall be responsible for:

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b) Managing and retaining research documents, managing assets, devices, drugs and materials used for the research as per regulations.

c) Maintaining confidentiality of clinical trial results for participants and overcoming problematic consequences to safeguard the health and life of participants.

Article 21. Rights of participants in clinical trial for medical equipment

1. Clinical trial participants shall be given adequate information on medical equipment and details of the test process, such as time, purpose, benefit and risk.

2. Clinical trial participants’ test data shall be kept confidential. Participants shall be safeguarded and compensated for any damage caused by the test as per the laws.

3. Participants shall be entitled to refuse or quit clinical trials at any time.

4. Clinical trial participants shall exempt from all expenses related to the test.

Article 22. Responsibilities of participants in clinical trial for medical equipment

1. Participants in clinical trials for medical equipment must adhere to the test procedure as per researchers’ guidelines. They must inform researches in advance of their withdrawal.

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FINANCE OF CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Article 23. Funding of clinical trials for medical equipment

1. Entities in possession of medical equipment shall fund clinical trials for medical equipment.

2. Finances for clinical trials for medical equipment in state-funded programs and studies shall be allocated from the overall budget of such programs and studies.

Article 24. Spending for clinical trials for medical equipment

1. The budget of a clinical trial for medical equipment shall cover expenses of the entire test. Such expenses include: Pay to workers, purchase of research materials, assessment of applications, verification of proposals, management, supervision, inspection, evaluation and acceptance of findings, assurance of participants’ benefits, rectification of menaces and other expenses incurred during the research.

2. Spending must adhere to current regulations on spending for science and technology and meet with assent by the funding organization, the principal investigator and the organizer.

3. The principal investigator and the lead organization shall estimate budget, explain and finalize spending as per regulations.

Chapter VIII

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Article 25. Procedure for evaluation and acceptance

1. The acceptance of results of clinical trials for medical equipment shall comply with current regulations on evaluation and acceptance of science and technology studies by Ministry of Health.

2. The acceptance process shall advance at two echelons: When the research ends, the principal investigator shall be responsible for reporting to the lead organization to accept research findings at grassroot level, finalize and deliver reports to the Ministry of Health of ministerial-level acceptance.

Article 26. Documents for evaluation and acceptance

The following documents shall be sent to Ministry of Health to conduct ministerial-level evaluation and acceptance:

1. The proposal (approved) of the research.

2. The decision on approval of the research title.

3. The decision on formation of the grassroot Council for evaluation and acceptance.

4. The meeting record of the grassroot Council.

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6. The full report of the research’s findings (Appendix 4), which has been revised as per the grassroot Council's opinions.

7. The lead organization’s request for ministerial-level acceptance.

8. Records of inspections and supervision by managing authorities (if any).

Article 27. Announcement of research findings

1. Results of a clinical trial for medical equipment shall only be announced after accepted by the Council of Science and Technology of the Ministry of Health.

Results of a clinical trial for medical equipment shall be announced upon assent by the entity in possession of the medical device or its representative, the organizer of the clinical trial and the principal investigator.

 2. Research findings announced must be genuine and accurate in unison with the conclusion by the Council for acceptance and by unanimous consent of the entity in possession of the medical device and the organizer of the clinical trial.

Chapter IX

IMPLEMENTATION

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Minister of Health assigns:

1. Department of Science and Training:

a) To take in applications and provide guidelines for entities in possession of medical equipment clinically tried to abide by this Regulation.

b) To assess applications.

c) To assess and recommend research grounds.

d) To supervise the research and conduct regular or ad-hoc inspections.

dd) To assess research findings.

2. Department of Medical equipment and Works to propose the list of medical equipment subject to clinical trial, to supervise and inspect the research, to obtain clinical trial results as scientific grounds for importation and sale of medical equipment.

3. Department of Treatment, Department of Maternal health, Department of Traditional medicine, Food safety and Hygiene Administration, General Department of Preventive Medicine, within authority, to receive feedbacks from actual operation of medical equipment and to report systematic problems during use to Minister of Health for discontinuation and remedial actions./.

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FOR MINISTER
DEPUTY MINISTER




Le Ngoc Trong

(The form of request by the entity in possession of the medical device for clinical trial)

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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… [place], … … … [date]

REQUEST FOR CLINICAL TRIAL FOR MEDICAL EQUIPMENT

To: MINISTRY OF HEALTH

Name of the organization:

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Telephone: Fax:

Email:

Account No.

This is to request the Ministry of Health to approve the clinical trial for medical equipment

1. Name of the medical device:

2. Type: Pursuant to TCVN 7391-1:2004 on biological evaluation of medical devices

Medical equipment that come into indirect contact

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Medical equipment that come into direct contact

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- Surface contact

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- Invasive contact

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- Transplant

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- Support of body functions

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3. Clinical trial is requested from: ............ to: .............

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+ The role of the medical device in diagnosis, prevention, control, treatment or mitigation of diseases. Compensation for injuries or disabilities, replacement, modification, surgery or contraception.

+ Does the medical device sustain or support life?

5. Use (Describe the medical device and substances that come into contact with tissues or body parts)

6. The medical device has passed: Research, preclinical research.

7. The device has been accepted at the level of grassroot, city, institute, ministry or industry:

8. Performance (specify the level of evaluation and conclusion according to the acceptance record: passed, excellent, good or …)

9. Enclosed with:

The application for clinical trial for medical equipment (Appendix 2);

The proposal of the clinical trial (Appendix 3);

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Documents that substantiate the legality of the medical device, with notarized translations.

The contract between the entity in possession of the medical device and the principal investigator/ the organization leading the clinical trial;

01 set of sample stickers for the medical device as per regulations.

The record of the grassroot Council’s assessment of the scientific and ethical aspects of the research.

We request the Ministry of Health to consider and approve the clinical trial for the said product.

The organization’s verification

(if a representative lodges this request for clinical trial)

We assign ... as our representative and request Ministry of Health to approve the clinical trial for our medical device.

Head of the organization

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(Local authority’s verification of the individual in possession of the medical device)

People’s Committee of Ward ... verifies that Mr/Ms. ... is residing in ward ... in permanent/ temporary residence.

FOR PEOPLE’S COMMITTEE

(Sign and seal)

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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……….… [place], … … … [date]

Name of the organizer of the clinical trial for medical equipment:

Address:

Telephone:

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Email:

We apply for the clinical trial for medical equipment:

1.      Name of the medical device:

2.      Type:

3.      Use:

4.      Batch n^o: Code:                 Expiry:

5.      The device made in quantity for clinical trial according to these standards (specify TCVN, TCN, TCCS)

6.      Quality of the device has been inspected by ..., which is the authority competent to inspect quality as per standards enclosed to this application.

7.      The quality inspection sheet n^o … dated … (specify the issue date of the quality inspection sheet)

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9.      Phase of clinical trial:

10.  Expected quantity for research:

 (The label of the medical device must indicate that it is made for research and not for sale)

We apply for the clinical trial for the medical device … at …

according to the Ministry of Health’s regulations on clinical trial for medical equipment.

Head
of the applicant
(sign and seal with full name)

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MINISTRY OF HEALTH RESEARCH PROPOSAL CLINICAL TRIAL FOR MEDICAL EQUIPMENT

1. Research topic

2. Code (as given by the supervisory authority)

3. Duration:

 (From … [month]/ …. [year] to … [month]/ ... [year])

4. Supervisory level

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 Province

5.

Outlay

Total:

from the …

(specify the source of finances: Science and Technology Fund, sponsorship, self-financed money, etc.)

6.

Origin of the research topic:

6.1. Research: - Accepted; - Not yet accepted

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 Result of the acceptance or evaluation by Science and Technology Council formed by Ministry of Health (specify: approval or disapproval of the clinical trial, request of repetition of experiments or preclinical trials, etc.)

6.2. Preclinical trial for medical equipment:

 - Preclinical trial performed: ........................................................................................

 - Accepted or evaluated by Science and Technology Council under Ministry of … or by government agency ...

 Result of the Council’s evaluation: .....................................................................................

 . Phase accepted: ......................................................................................

 . Request of permission for the preclinical trial for medical equipment at phase: ...........................................................

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 Topic of the preclinical trial for medical equipment in the phase (in detail):

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8

Principal investigator}

Full name:

Academic title/ academic degree:

Academic rank:

Telephone: (Office)/ (Home) Fax:

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Email:

Office address:

Home address:

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The organizer of the clinical trial for medical equipment (Lead organization)

Name of the organization in science and technology:

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Address:

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Organization or individual in possession of the medical device clinically tried (the entity permitted to use the copyright of the device pre-clinically tried and the result of the preclinical trial to proceed to production, real-life deployment or subsequent research)

Name of the organization

Telephone: Fax: Email:

Office address:

Full name (of the individual)

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Academic rank:

Telephone: (Office)/ (Home) Fax:

Mobile:

Email:

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Home address:

 (Explanation of sections as per the Preclinical trial guideline for contents of the proposal at various phases)

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Objective:

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Local and overseas clinical trials for the medical device

·         Research topic  New                    Following the study finished at the previous phase

·         Description of the medical device (technology, technical features, product quality, process of use and operation, evaluation method, possible risks and hazards and safety measures for participants or organizers)

·         Overview of clinical trials for the medical device:

Overseas:

Local:

·      List clinical trials related to the medical device, which have been announced in the last 10 years.

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Approach, research method, techniques (elucidate the approach, research design, sampling, sample size, criteria for research subjects, research methods, techniques to be employed - in comparison with equivalent methods, research values, technical means, equipment for determination of research figures, originality, uniqueness and creativity of the design and methods of this study)

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Research content (list and describe contents to be studied, indicate new and suitable contents to solve questions and attain research objectives, cooperation activities expected to transfer research findings to users)0}

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International cooperation

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Detail

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Progress

No.

Main contents and tasks

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Outcome desired

Time
(Start - End)

Person, organization in charge

1

2

3

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5

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Form of research result desired

¨      Graph

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¨      Analysis report, conclusions regarding the effect, suitability and safety of the medical device

¨      Forecast for subsequent clinical trials for the medical device

¨      Directions for use of the medical device

¨      Procedure for use

¨      Other outcomes

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Requirements for outcomes

No.

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Scientific requirement

Note

(1)

(2)

(3)

(4)

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2

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4

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Method for transfer of research findings

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Effect of research findings (apart from those declared in Section 18)

·      Training of personnel in science and technology

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·      On economy - society:

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Activities of organizations that cooperate to perform the research

 (Indicate all organizations that cooperate to perform the research and their tasks)

No.

Name of the organization

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Activity/ contribution to the research

1

2

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Connection with production and life

(Indicate producers or users of research findings, which participate in the research and their tasks)

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 Performers of the research

 (Specify at most 10 main individuals from lead organizations, who contribute to the research)

No.

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Employer

% of time spent on the research

A

Principal investigator

B

...

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1

2

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Unit: Million dongs (VND)

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Spending for the research

No.

Source of fund

Total

Including

Fixed employment

Materials and energy

Machines, equipment

Construction, minor repair

...

...

...

1

2

3

4

5

6

7

8

...

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Including:

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1

Science budget

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2

Other sources (specify)

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- Self-financed

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- Others (mobilized capital, etc.)

......... ……… [place], ... … … [date]

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Principal investigator
(Sign and full name)

......... ……… [place], ... … … [date]
BY ORDER OF MINISTER
HEAD OF DEPARTMENT OF SCIENCE AND TRAINING

...

...

...

Appendix

Unit: million dongs

No.

Spending

Total

Source

Amount

Ratio (%)

State budget

...

...

...

Others

1.

Fixed employment

...

...

...

Materials and energy

3.

Special equipment and machines

...

...

...

4.

Construction, minor repair

...

...

...

5.

Others

...

...

...

EXPLANATION OF SPENDING

...

...

...

No.

Entry

Total expenditure

Source

State budget

Self-financed

Others

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

Section 2: Materials and energy

No.

Entry

Measuring unit

Quantity

Unit price

Amount

Source

...

...

...

Self-financed

Others

2.1

Materials

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

 Tools and spare parts

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

2.3

Energy and fuel

...

...

...

 - Coal

...

...

...

 - Electricity

kW/h

...

...

...

 - Petrol and oil

...

...

...

 - Other fuels

...

...

...

2.4

 Water

m^3

...

...

...

2.5

 Purchase of boos, documents, data

...

...

...

No.

...

...

...

Measuring unit

Quantity

Unit price

Amount

Source

State budget

Self-financed

Others

3.1

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

3.2

Purchase of test and measuring equipment

...

...

...

...

...

...

...

...

...

...

...

...

3.3

Equipment depreciation

...

...

...

...

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3.4

Rent of equipment

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...

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...

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3.5

Transport and installation

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...

...

...

...

...

...

...

...

...

...

...

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Section 4. Construction and minor repair

No.

Entry

...

...

...

Source

State budget

Self-financed

Others

4.1

Cost of construction of      m^2 of factory or laboratory

...

...

...

4.2

Cost of repair of      m^2 of factory or laboratory

4.3

Cost of installation of electrical and water systems

...

...

...

4.4

Other costs

...

...

...

Total

...

...

...

Section 5. Other expenses

No.

Entry

Amount

Source

State budget

Self-financed

...

...

...

4.1

Business trip

...

...

...

4.2

...

...

...

...

...

...

4.3

Evaluation, inspection, acceptance

- Intermediary inspection and acceptance

...

...

...

- Internal acceptance

...

...

...

- Official acceptance

4.4

Others

...

...

...

- Seminar

...

...

...

- Printing, stationery

...

...

...

- Translation

........

...

...

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4.5

Allowance for Principal investigator

...

...

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REPORT ON CLINICAL TRIAL FOR MEDICAL EQUIPMENT

...

...

...

Principal investigator:

Lead organization:

Research title code (if available):

...

...

...

Cover page 2

REPORT ON CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Research title:

...

...

...

Lead organization:

Supervisory level: Ministry of Health

Research title code (if available):

Duration: from … [month] … [year] to … [month] … [year]

Total expenditure: … million dongs  

From: science and technology fund: … million dongs          

Other sources (if any) … million dongs         

...

...

...

Year of …

Page 3

1.      Research title:

2.      Principal investigator:

3.      Lead organization

4.      Supervisory organization:

5.      Secretary:

...

...

...

7.      Main performers:

8.      Branch studies (headings) of the research (if any)

 (a) Branch study 1 (heading 1)

- Name of the branch study:

- Principal investigator of the branch study:

 (b) Branch study 2

- Name of the branch study:

- Principal investigator of the branch study:

9.      Duration: from … [month] … [year] to … [month] …[year]

...

...

...

Page 4

TABLE OF CONTENTS

Part A - Summary of prominent findings (at the discretion of the principal investigator)

1.                              Prominent findings of the research

2.                              Application into production and society

3.                              Evaluation of research performance in comparison with the proposal approved

(a)                                        Progress

...

...

...

(c)                                        Outcomes gained in comparison with the proposal

(d)                                       Evaluation of spending

4.                              Recommendations

Part B. Report on details of findings of ministerial-level research

1.                              Introduction:

1.1.                                    Summary of domestic and overseas studies related to the research Urgency of the research

1.2.                                    Hypotheses of the research

1.3.                                    Objectives of the research

2.                              Overview:

...

...

...

2.2.                                    Domestic studies in connection with the research

3.                              Subject and method of the research:

3.1.                                    Design of the research

3.2.                                    Sampling, sizing and research subject

3.3.                                    Research methodology

3.3.1.                              Research values

3.3.2.                              Method for determination of research values

3.3.3.                              Research instruments

3.4.                                    Data processing method

...

...

...

4.1 Brief description of the medical device’s intended functions, type, technology, traits and use.

4.2 Analysis of documents and data selected, advantages and disadvantages

4.3 Evaluation of relevant risks and hazards and safety measures for patients and medical personnel.

4.4 Summary of effects on health conditions of clinical trial performers.

5.                              Discussion:

6.                              Conclusion and recommendation:

7.                              Reference document:

8.                              Appendix (if any): ...

...

...

...

CLINICAL TRIAL SHEET

1.                  Location of the clinical trial

-          Name of the clinical trial facility:

-          Address:

-          Telephone:

2.                  Date that the clinical trial starts (specify the actual date but not the date that the written approval is signed)

3.                  Description of the medical device

-          Name of the medical device:

-          Feature and function:

...

...

...

-          Full name:                                                 Age:                            Gender:

-          Address:

-          Telephone:

-          Height:                                          Weight:

-          Blood pressure:                                                     Cardiovascular condition:

-          Initial health condition:

5.                  Diagnosis and anticipation of dosage, duration and side effect

6.                  Supportive drugs during the process

7.        Values to be monitored during the process (specify)

...

...

...

9.                  Evaluation and conclusion

10.    Date that the clinical trial ends

Signature of the performer of the clinical trial

APPENDIX 6

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
--------------

ATTESTATON OF CONSENT TO PARTICIPATE IN CLINICAL TRIAL

(Including these main details)

...

...

...

Representative:

Address:

Telephone:

Party B. The participant in the clinical trial

Full name:

Address:

Or Legal representative

Address:

Telephone:

...

...

...

Article 1. Party A is responsible for providing this information:

Purpose of the test

Duration of the test

Benefits from the test

Article 2. Party A's responsibilities

Undertake to maintain safety of participants;

Undertake to recompense as per the laws for damage caused by the clinical trial;

Undertake to maintain confidentiality of the participant/

Article 3. Party B voluntarily participates in the clinical trial.

...

...

...

PARTY A’S REPRESENTATIVE

PARTY B’S REPRESENTATIVE

APPENDIX 7

GUIDELINE FOR ASSESSMENT OF THE RESULT OF THE CLINICAL TRIAL FOR MEDICAL EQUIPMENT

1.                  Ministry of Health forms the Council that shall assess and accept the result of the clinical trial for medical equipment upon its receipt of sufficient documents as per Article 25 of the Regulation on clinical trial for medical equipment.

2.                  Upon its review of all documents, reports and relevant papers, the Science Council shall assess the research in 4 stages:

a.                                           Study documents of the clinical trial

...

...

...

c.                                           Cast vote and give grade

d.                                          Finalize and report the assessment

3.                  Criteria for assessment: five categories with the maximum grade of 50 as follows:

No.

Criteria

Highest point

3.1

Fulfillment of the research's basic works

12

...

...

...

Adequacy of quantity and volume of basic works fulfilled according to the clinical trial contract (between the entity in possession of the medical device and the organizer of the test)

4

b

Research method (sampling, sizing, techniques, experimental authenticity, representativeness of tests, figures, etc.)

4

c

Completeness of science reports (statement, summary report, document, data, clinical trial record, preclinical trial record, other papers, duration, progress and expenditure)

4

3.2

...

...

...

12

a

Attainment of goals of the clinical trial

+ Result of the test method planned with clinical reality

+ Does result of the clinical trial indicate full evaluation and anticipation of risks and adverse effects of the device and solutions?

4

b

Assessment of latent risks and recommendation of safety measures for patients, medical personnel and individuals concerned

4

...

...

...

Ethical assessment

+ Health condition of performers of the clinical trial after their use of the device

+ Expertise and experience of performers of the clinical trial

4

3.3

Scientific value of the result of the clinical trial

8

a

Scientific value, originality and creativity of the research

...

...

...

b

Announcement of research findings (on newspaper and publications)

4

3.4

Practical value of the result of the clinical trial

8

a

Practical applicability of research findings

4

...

...

...

Economic - social effects of the research

4

3.5

Assessment of organization and management, training and other contributions

10

a

Assessment of research organization and management

4

b

...

...

...

4

c

Other contributions

2

4.                  The research fails in one of these events:

a. Basic works under the contract are partially or entirely failed.

b. Research findings are of no use.

c. Documents or data is not credible.

d. Goals and plan change in a subjective manner.

...

...

...

f. Submission of the application for acceptance is deferred for 6 months or more after the deadline of the research without permission by Ministry of Health.

5.                  Council bases on the result of grading and voting to rank the research:

             Pass: Not violating Point a, b, c, d, e or f in Section 4

The research must score at least 25

Rank A: 40 ¸ 50 points

Rank B: 30 ¸ 40 points

Rank C: 25 ¸ 30 points

            Fail: Below 25 points or violate either Point a, b, c, d, e or f in Section 4.

6.                  Council review and assess the result of the research.

...

...

...

            Further clinical trial is requested.

            Other recommendations

SHEET FOR ASSESSMENT AND REMARK

RESULT OF THE CLINICAL TRIAL FOR MEDICAL EQUIPMENT

Defender

Member

...

...

...

Code:

2. Principal investigator:

3. Lead organization:

4. Members of the assessment Council:

a. Full name:

b. Expertise:

c. Date of receipt of the application for assessment:

d. Date of return of the application for assessment:

5. Assessment criteria:

...

...

...

Criteria

Highest point

Points given by specialists

5.1

Fulfillment of the research's basic works

12

a

Adequacy of quantity and volume of basic works fulfilled according to the clinical trial contract (between the entity in possession of the medical device and the organizer of the test)

...

...

...

4

b

Research method (sampling, sizing, techniques, experimental authenticity, representativeness of tests, figures, etc.)

Remark:

4

...

...

...

Completeness of science reports (statement, summary report, document, data, clinical trial record, preclinical trial record, other papers, duration, progress and expenditure)

Remark:

4

5.2

Fulfillment of research contents

12

...

...

...

Attainment of goals of the clinical trial

+ Result of the test method planned with clinical reality

+ Does result of the clinical trial indicate full evaluation and anticipation of risks and adverse effects of the device and solutions?

Remark:

4

b

Evaluation of latent risks and recommendation of safety measures for patients, medical personnel and individuals concerned

...

...

...

4

c

Ethical assessment

+ Health condition of performers of the clinical trial after their use of the device

+ Expertise and experience of performers of the clinical trial

Remark:

...

...

...

5.3

Scientific value of the result of the clinical trial

8

a

Scientific value, originality and creativity of the research

Remark:

...

...

...

b

Announcement of research findings (on newspaper and publications)

Remark:

4

5.4

Applicability of the result of the clinical trial

...

...

...

a

Practical applicability of research findings

Remark:

4

b

Economic - social effects of the research

...

...

...

4

5.5

Assessment of management, training and other contributions

10

a

Assessment of research organization and management

...

...

...

4

b

Result of training

Remark:

4

...

...

...

Other contributions

Remark:

2

Total point

50

6. General remark on the result of the research

...

...

...

 (this part only applies when the research is "Failed")

8. Opinions of members of the Council on unsolved issues and their recommendations

COUNCIL MEMBER

(Sign and write full name)