Chương IX Nghị định 98/2021/NĐ-CP: Thông tin trang thiết bị y tế

Chapter IX

INFORMATION ON MEDICAL DEVICES

Article 61. 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.

Article 62. 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.