CONTENTS
- 1. New Medical Technology Assessment | Concept
- - Legal basis
- - Registered as a medical device
- 2. New Medical Technology Assessment | Standard
- - Skills
- - Company
- - Evaluation result Notice and sympathy
- 3. Medical Technology Assessment | Procedure
- - Application and Courses
- - About Us
- - Gallery
- 4. New Testament Technology Assessment | Customization Strategy
1. New Medical Technology Assessment | Concept
“medical law” Article 53 and Korean medical research institutes are assessed based on the implementation of the law; this system is functional as a required procedure for the patient’s life and health protection. News /span>
The technology that does not pass the evaluation is prohibited from use in the medical institution, The salary examination for health insurance coverage is also not allowed. News /span>
Legal basis
New medical technology evaluation is operated based on three laws: News /span>
▶ National Health Insurance Law
If it is classified as a research stage technology, not a new medical technology, If it is not high, the pay application requirement is not met. <% var comment path = (typeof window == 'undefined') ? '/fcv/tpl/comments/' : ''; list = list.reverse(); var showMore = (comment.total cnt > 3) %> 61%, 41% );">▶ Began Medical Technology Promotion Act
Registered as a medical device
New medical technology evaluation target means new medical technologies that are not listed on national health insurance salary or non-insurance list. Comforts are as follows: News /span>
One-time, Treatment of disease without work or daily life (e.g.: beauty, eye correction, health checks, etc. by the hope of the main person) is subject to non-Korean health insurance.
2. New Medical Technology Assessment | Standard
is based on the technique of class="color-colored" class="colored"
">The simple technical novelty alone cannot be recognized as a new medical technology, the objective comparison analysis and reference based evaluation are essential.
Skills
If the patient has applied such medical technology, it assesses whether the risk factors related to side effects, complications, etc. are acceptable.
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Company
The medical technology of the disease improves the diagnosis accuracy, therapeutic effect, improves the symptoms, improves the quality of life, etc.
This standard focuses on whether the technology can induce clinically meaningful results on the technology simply ‘operation’, News /span>
Evaluation result Notice and sympathy
The health care department is clear to the safety and validation of the results of the new medical technology evaluation. News /span>
Specification of the existing medical technology at the time of implementation, For example, in the case of procalcitonin quantitative test, enzymatic chromatographic analysis, News /span>
This wonderful contrast ensures the continuity and legality of existing healthcare activities, supports realistic application of evaluation results. News /span>
3. Medical Technology Assessment | Procedure
in case of technology that contains medical equipment, in case of medical device authorization of the medical device and the similar technical verification of health insurance policy. News /span>
Application and Courses
Applications
">to apply for medical institutions or medical devices manufacturing and importers. News /span>
">Personal Committee Composition
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The Committee consists of the maximum 10. News /span>
Sofacing
span style="color:black;and. News /span>
2 secondary subcontractor:
About Us
General evaluation required period is max 250days until application acceptance.
external diagnostics and gene inspection related technologies are subject to rapid evaluation, in this case, max 140 days(maximum 110 days extension).
Gallery
✅ The so-called committee is usually 3~4 times, may vary depending on the characteristics of the application technology. News /strong>
✅ The application of the commissioner is provided for the comments in writing or video manner. News /strong>
✅ Each aspect of the evaluation process is disclosed to the applicant, the expression is made.
only, final evaluation results are kept private until the end of the new medical technology evaluation committee.
✅ If the application technology is classified as a static research stage technology in the trial committee of the medical technology, the application will be given separately to the applicant's screening or video feedback.
4. New Testament Technology Assessment | Customization Strategy
To enter the fast and efficient market of medical technology evaluation, it is important to accurately identify the requirements and characteristics of the institution, it is important to sort the most appropriate entry path for the solution.
It may vary depending on the scheme you choose. News /span>
This company provides customized strategy advice on which scheme should be used to enter the most promptly medical field. News /span>
In addition to the evaluation application, the clinical trial plan is created and evaluated at the stage, Safety·Effective evidence material composition advice, Safety strategy establishment etc., Support. News /span>
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