What are the required contents of an advertisement for a medical device in Vietnam? What are the obligations of advertisers of a medical device?
What are the required contents of an advertisement for a medical device in Vietnam?
Pursuant to Article 62 of Decree 98/2021/ND-CP stipulating as follows:
Advertising of medical devices
1. Contents of an advertisement for a medical device must be consistent with one of the following documents:
a) The application for declaration of applied standards of Class-A or Class-B medical device;
b) The application for registration of Class-C or Class-D medical device.
2. An advertisement for a medical device shall, inter alia, have the following information:
a) Name, category, product code, manufacturer and manufacturing country of the medical device;
b) Registration number;
c) Functions and uses;
d) Name and address of the registration number holder or the entity authorized by the registration number holder;
dd) Warnings for medical device users and storage conditions (if any).
3. Audio or video advertisement must contain sufficient information specified in Clause 2 of this Article which must be read or displayed clearly.
4. 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.
5. 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.
6. 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.
According to the above regulations, 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).
In addition, contents of an advertisement for a medical device must also 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.
What are the required contents of an advertisement for a medical device in Vietnam? What are the obligations of advertisers of a medical device?
Vietnam: What are the obligations of advertisers of a medical device?
Pursuant to Article 12 of the Law on Advertising 2012 stipulates as follows:
Rights and obligations of advertisers
1. Advertisers are entitled to:
a) Advertise their products, goods, services, organization and individual;.
b) Make decisions on the forms and methods of advertising;
c) Receive information from local agencies in charge of advertising about the approved outdoor advertising planning;
d) Request advertisement appraisal;
2. Advertisers have the following obligations:
a) Providing the advertising service providers or advertisement publishers with accurate information about the agencies, organizations, individuals, products, goods, services and the documents related to the advertising conditions and being responsible for such information.
b) Ensuring that the product, goods and service quality is consistent with the advertisements;
c) Being responsible for their advertisements when directing advertising on the means of advertising; or being jointly responsible for the advertisements when hiring others to advertise;
d) Providing documents related to the advertisements at the request from the advertisement receiver or competent State agencies.
3. Other obligations and rights as prescribed by law.
Accordingly, when advertising medical equipment, advertisers have the following obligations:
- Providing the advertising service providers or advertisement publishers with accurate information about the agencies, organizations, individuals, products, goods, services and the documents related to the advertising conditions and being responsible for such information.
- Ensuring that the product, goods and service quality is consistent with the advertisements;
- Being responsible for their advertisements when directing advertising on the means of advertising; or being jointly responsible for the advertisements when hiring others to advertise;
- Providing documents related to the advertisements at the request from the advertisement receiver or competent State agencies..
What is the responsibility for disclosing information on a medical device in Vietnam?
Pursuant to Article 61 of Decree 98/2021/ND-CP stipulating as follows:
Information on medical devices
1. 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.
2. Information on a medical device must be adequate, objective, accurate, truthful and easily understandable and must not cause misunderstanding.
3. Responsibility to provide information on medical devices:
a) Registration number holders and trading establishments shall publish information on levels of risks and other information related to the use of medical devices;
b) Health facilities shall internally disseminate information on medical devices;
c) Health workers shall disseminate information on levels of risks of Class-C, D medical devices to patients;
d) Authorities in charge of managing medical devices shall make information on medical devices publicly available.
4. Providers of information on medical devices shall assume responsibility for their provided information.
5. The Minister of Health shall organize a medical device information system.
Thus, the responsibility to provide information on medical devices is as follows:
- 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.
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