Does a high-risk medical device need to be clinically tested on patients before registration for circulation in Vietnam?
Does a high-risk medical device need to be clinically tested on patients before registration for circulation in Vietnam?
This content is specified in Section 2, Chapter VIII of the 2023 Law on Medical Examination and Treatment in Vietnam, specifically as follows:
Medical equipment, before being registered for circulation in Vietnam, has a medium-high risk level or a high level of risk according to the Government's regulations in one of two cases of clinical trial in medical examination and treatment.
Participants in clinical trials in medical examination and treatment must satisfy the conditions specified in Article 95 of the 2023 Law on Medical Examination and Treatment in Vietnam as follows:
Conditions of clinical trial participants in medical examination and treatment
1. Persons who satisfy the professional requirements of clinical trials of new techniques, new methods, medical equipment in medical examination and treatment (hereinafter referred to as clinical trials) and voluntarily participate in a clinical trial.
2. In case a clinical trial participant is a person who has lost civil act capacity, has difficulties in perception, behavior control, limited civil act capacity, minors must be consent of the representative or guardian in accordance with the provisions of civil law.
3. In case a clinical trial participant is the subject specified in Clause 2 of this Article, a pregnant or lactating woman, the research dossier must clearly state the reasons for selection and appropriate measures to protect clinical trial participants, fetuses or children who are using the mother's milk participating in clinical trials.
Thus, clinical trial participants must also meet the professional requirements of medical device clinical trials and voluntarily participate in clinical trials.
Does a high-risk medical device need to be clinically tested on patients before registration for circulation in Vietnam?
What are the rights of clinical trial participants in Vietnam?
Pursuant to the provisions of Article 96 of the 2023 Law on Medical Examination and Treatment in Vietnam as follows:
Rights and obligations of clinical trial participants in Vietnam
1. Clinical trial participants have the following rights:
a) Be provided with complete and truthful information about the clinical trial and possible risks before the clinical trial;
b) Be compensated for damage (if any) caused by the clinical trial;
c) keep confidential personal information related to the clinical trial;
d) Not be responsible for unilaterally terminating the participation in clinical trials;
d) Complaints, denunciations and lawsuits about illegal acts of organizations and individuals that have new techniques, new methods, or medical devices subject to clinical trial.
2. Clinical trial participants are obliged to follow the instructions according to the approved clinical trial records.
Thus, clinical trial participants are entitled to the following rights;
- Be provided with complete and truthful information about the clinical trial and possible risks before the clinical trial;
- Be compensated for damage (if any) caused by the clinical trial;
- Keep confidential personal information related to the clinical trial;
- Not be responsible for unilaterally terminating the participation in clinical trials;
- Complaints, denunciations and lawsuits about illegal acts of organizations or individuals having new techniques, new methods or medical equipment subject to clinical trial.
In addition, clinical trial participants must follow the guidelines of the approved trial record.
What are the principles and authority to approve clinical trials?
According to the provisions of Article 99 of the 2023 Law on Medical Examination and Treatment in Vietnam, this content is as follows:
- Clinical trials performed before the application of new techniques, new methods or registration of circulation of medical devices, except for cases of exemption from clinical trials or exemption from certain phases of clinical trials.
- A clinical trial can only be performed after it has been scientifically and ethically evaluated by the Ethics Committee in Biomedical Research specified in Clause 3, Article 99 of the 2023 Law on Medical Examination and Treatment in Vietnam for the clinical trial record and approved in writing by the competent authority.
The Biomedical Research Ethics Committee is an independent committee established to protect the rights, safety, and health of clinical trial participants.
- Clinical trials, scientific and ethical reviews of clinical trial records and clinical trial approvals are performed according to the following basic principles:
+ Respect, protect and ensure the right to self-determination of clinical trial participants;
+ Ensure that the benefits of the study outweigh the potential risks during the clinical trial;
+ Equality in benefits and responsibilities; ensure that risks are evenly distributed to clinical trial participants;
+ Ensure the implementation of clinical trial stages and compliance with good practice of testing new techniques, new methods or clinical testing of medical devices as prescribed by the Minister of Health.
The 2023 Law on Medical Examination and Treatment in Vietnam takes effect from January 1, 2024.
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