Clinical study dossiers on medical device in Vietnam

Clinical study dossiers on medical device in Vietnam (Source: Internet)

1. What is medical device?

According to Clause 1, Article 2 of Decree 98/2021/ND-CP, "medical device” means any instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets all of the following requirements:

- It is intended, by the product owner, to be used, whether alone or in combination, for human beings for the purpose of one or more of the following:

+ diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or trauma;

+ investigation, replacement, modification or support of the anatomy or of a physiological process;

+ supporting or sustaining life;

+ control of conception,

+ disinfection of medical devices;

+ providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body.

- The device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means to serve the purposes mentioned in Point a of Clause 1, Article 2 of the Decree. 98/2021/ND-CP.

2. Clinical study dossiers in Vietnam

A clinical study dossier consists of the following application for approval to conduct clinical study, application for approval of changes to clinical study, and application for approval of clinical study results.

2.1. Application for approval to conduct clinical study in Vietnam

An application for approval to conduct clinical study consists of:

- The application form for approval to conduct clinical study.

- Documents about the medical device undergoing the clinical study, including:

+ Description of the investigational product (general information about the investigational medical device, including: name, specifications, uses and other relevant information);

+ Documents about pre-clinical study on the investigational medical device, including: study report on the safety and efficacy of the medical device, and recommendations for use and storage of the device;

+ Documents about previous stages of the clinical study on the medical device (in case an application for following-stage clinical study is submitted and the medical device is not exempt from previous clinical study stages).

- Legal documents about the medical device undergoing the clinical study, including:

+ Technical documents for medical device;

+ Technical standards and records of testing/inspection of the medical device issued by competent authorities;

+ The user manual if the medical device undergoes stage-3 clinical study;

+ Certifications of participation given by research institutions in a multi-center clinical study conducted in Vietnam;

+ The cooperative agreement on clinical study between the authority, organization or individual whose medical device undergoes the clinical study and the clinical study service provider; the cooperative agreement between organization or individual whose medical device undergoes the clinical study and the sponsor of the clinical study (if any).

- Clinical study protocol and protocol description, including: Description of the clinical study on medical device and questionnaires or CRFs (Case Report Forms).

- Scientific CV and copy of certificate of completion of GCP training course, issued by the Ministry of Health or qualified GCP training program provider, of the principal investigator.

- Informed consent forms given by the clinical study volunteers.

- The record of review of ethical and scientific aspects of the clinical study made by the Internal Ethics Committee.

- Label of the medical device as prescribed in Clause 3 Article 13 of this Decree and instructions for use of the investigational medical device.

(Clause 1, Article 15 of Decree 98/2021/ND-CP)

2.2. Application for approval of changes to clinical study in Vietnam

An application for approval of changes to clinical study consists of:

- The application form for approval of changes to clinical study.

- Updated versions of the corresponding documents specified in Clause 1 of this Article, as changed.

- Review record made by the Internal Ethics Committee if changes to the clinical study may affect the health and benefits of the participants or the design, process and procedures of the clinical study.

(Clause 2, Article 15 of Decree 98/2021/ND-CP)

2.3. Application for approval of clinical study results in Vietnam

An application for approval of clinical study results consists of:

- The application form for approval of clinical study results.

- The copy of the approved clinical study protocol;

- The copy of the decision on approval of the clinical study protocol;

- The record of review of clinical study results made by the Internal Ethics Committees;

- The full text of the report on clinical study results.

(Clause 2, Article 15 of Decree 98/2021/ND-CP)

3. Requirements for clinical study on medical devices in Vietnam

3.1. Requirements for medical devices undergoing clinical study in Vietnam

Clinical research medical equipment needs to meet the requirements specified in Article 13 of Decree 98/2021/ND-CP, specifically as follows:

- The medical device meets quality standards specified in the clinical study application.

- Technical parameters of the medical device have been duly inspected to ensure its quality and safety.

- The medical device must be labeled as “for clinical study only - not for any other purposes”. The labeling of medical devices shall comply with regulations of law on labeling of goods.

3.2. Requirements for organizations conducting clinical study on medical devices in Vietnam

According to Article 14 of Decree 98/2021/ND-CP, an organization conducting clinical study on medical devices is required to meet the following requirements:

- It is a scientific research institution that is independent from the organization or individual whose medical device undergoes clinical study.

- It must have clinical study laboratory or site, quality control system and technical documents that meet the Good Clinical Practice (GCP) guidelines adopted by the Minister of Health.

- It has adequate human resources to conduct clinical studies, including:

+ Principal investigator who must have appropriate professional qualifications and competence in research, and experience in clinical practice and use of medical devices, have a thorough grasp of regulations on science and technology management and codes of ethics in research, and be capable of conducting clinical study on medical devices.

+ Researchers who must have professional qualifications and competence meeting research requirements, and have completed training courses in knowledge and skills in clinical study on medical devices.

Thanh Rin

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