What are rules for management and use of medical devices in Vietnam?

What are rules for management and use of medical devices in Vietnam?

According to the latest regulations, what are rules for management and use of medical devices in Vietnam? Thank you!

Answer:

Pursuant to Article 63 of the Decree 98/2021/NĐ-CP stipulating rules for management and use of medical devices in Vietnam as follows:

1. Medical devices must be properly managed and used to ensure their functions as well as economical and effective use.

2. Medical devices shall be stored, maintained and used in accordance with the manufacturer's instructions, and must undergo quality in accordance with regulations of this Decree.

With regard to medical devices subject to strict occupational safety and health requirements, regulations of the Law on occupational safety and health must be strictly complied in addition to regulations on quality control laid down in this Decree.

3. Documents on medical devices must be adequately prepared, managed and retained; medical devices shall be sufficiently and punctually recorded according to their actual state and values in accordance with regulations of laws on accounting and statistics and other relevant laws; funding for performing tasks prescribed in Clause 2 of this Article must be ensured.

4. Health facilities shall bear inspection of regulatory authorities in charge of managing medical devices.

What are regulations on information on medical devices in Vietnam?

I want to ask about latest regulations on information on medical devices in Vietnam. Thank you!

Answer:

Pursuant to Article 61 of the Decree 98/2021/NĐ-CP stipulating information on medical devices in Vietnam as follows:

- Information on a medical device is meant to provide medical practitioners and medical device users with instructions on how to use the medical device reasonably and safely.

- Information on a medical device must be adequate, objective, accurate, truthful and easily understandable and must not cause misunderstanding.

- Responsibility to provide information on medical devices:

+ Registration number holders and trading establishments shall publish information on levels of risks and other information related to the use of medical devices;

+ Health facilities shall internally disseminate information on medical devices;

+ Health workers shall disseminate information on levels of risks of Class-C, D medical devices to patients;

+ Authorities in charge of managing medical devices shall make information on medical devices publicly available.

- Providers of information on medical devices shall assume responsibility for their provided information.

- The Minister of Health shall organize a medical device information system.

What are regulations on advertising of medical devices in Vietnam?

I want to know about latest regulations on advertising of medical devices in Vietnam. Thank you!

Answer:

Pursuant to Article 62 of the Decree 98/2021/NĐ-CP stipulating advertising of medical devices in Vietnam as follows:

- Contents of an advertisement for a medical device must be consistent with one of the following documents:

+ The application for declaration of applied standards of Class-A or Class-B medical device;

+ The application for registration of Class-C or Class-D medical device.

- An advertisement for a medical device shall, inter alia, have the following information:

+ Name, category, product code, manufacturer and manufacturing country of the medical device;

+ Registration number;

+ Functions and uses;

+ Name and address of the registration number holder or the entity authorized by the registration number holder;

+ Warnings for medical device users and storage conditions (if any).

- Audio or video advertisement must contain sufficient information specified in Clause 2 of this Article which must be read or displayed clearly.

- Before carrying out the advertising of a medical device, the registration number holder or the entity authorized in writing by the registration number holder shall publish on the Portal on management of medical devices planned contents and form of advertising.

- The registration number holder or the entity authorized in writing by the registration number holder shall assume legal responsibility for the conformity of advertisement contents with the published ones and the application for declaration of applied standards of Class-A or Class-B medical device or the application for registration of Class-C or Class-D medical device.

- Documents or materials that do not contain name of a medical device, those that contain name and technical specifications of the medical device but do not contain functions or uses of the medical device, scientific research documents, clinical documents, and documents used for training in use of a medical device shall not be considered as advertising documents.

Best regards!