NOTES FOR ADVERTISING ACTIVITIES OF MEDICAL EQUIPMENT ON ONLINE PLATFORM

1. Conditions for advertising medical equipment

Article 20.4.g of Consolidated Document No. 47/VBHN-VPQH Advertising Law 2018 (“Consolidated Document”) stipulates conditions for advertising medical equipment requiring a free sale license for local medical devices manufacturer or import license for imported medical equipment.

In addition, according to Circular 09/2015/TT-BYT, the advertiser must also certify the advertisement content according to Article 9 with the following conditions:

- Must meet the advertising conditions specified at point g clause 4 Article 20 of the Law on Advertising.

- The advertising content must comply with the provisions of Article 7 of Decree No. 181/2013/ND-CP.

- Having sufficient documents as prescribed in Article 18 of Circular 09/2015/TT-BYT.

- The unit requesting certification of advertising contents is the unit named on free sale license for local medical devices manufacturer or import license for imported medical equipment or a representative office in Vietnam. Name of the unit named on the import license or the unit with legal status whose name is on the certificate of free sale registration for local produced products or the import license for imported products authorization in writing.

2. Application for certification of medical equipment advertisement content

To meet the conditions for certification of advertising content for medical equipment, an application file under Article 18 of Circular 09/2015/TT-BYT must be submitted, including:

- A set of documents with documents:

• A written request for certification of advertising content as prescribed in Appendix 01 issued with Circular 09/2015/TT-BYT;

• The business registration certificate of the enterprise or the license to establish a representative office of the foreign trader;

• Content of request for advertisement confirmation:

• If advertising in audio and video newspapers, there must be 1 record of the expected advertising content in the picture disc, audio disc, and floppy file, together with 03 expected advertising scenarios, which clearly describe the content, media to be advertised, the image part (for photojournalism), the lyrics, the music part;

• If advertising on advertising media other than audio and video newspapers, there must be 03 copies of the advertising content to be printed in color, together with a soft file recording the expected advertising content;

• Samples of product labels or samples of product labels that have been approved by a competent health authority in cases where the law requires that the product label be approved by a competent health authority.

• Requirements for dossiers submitted at agencies providing online public services at level 4: Dossier to be converted into soft files.

- License to import medical equipment or certificate of free sale of medical equipment.

3. Procedures for applying a certificate of medical device advertising content

Procedures for applying a certificate of advertisement content are prescribed as follows:

- Submit your application at the Department of Medical Equipment and Works under the Ministry of Health.

- Within 05 working days, the application-receiving agency shall send a written request to the unit to amend and supplement.

- The maximum time for the requester to confirm the advertising content to amend, supplement and complete the dossier upon maximum request is 90 days.

- Within 10 working days from the date of receipt of complete and valid dossiers, competent state agencies shall issue certificates of advertisement contents. In case of refusal to issue a certificate of advertisement content, the competent state agency must reply in writing and clearly state the reasons for not granting it.

- The application-receiving agency is responsible for publishing on its website the list of products, goods, and services under its management that have been granted a certificate of advertisement content.

4. Note for advertising medical equipment on online platforms

Article 23, Article 24 of the Consolidated Document provides for advertising on online platforms, specifically electronic newspapers, and websites as follows:

- Do not design, arrange advertising parts mixed with content of news;

- For ads that are not in a fixed area, it must be designed so that readers can actively turn off or open the ads, the maximum time to turn on or off the ads is 1.5 seconds.

- Advertisements on websites of foreign organizations and individuals doing business in cross-border advertising services and generating advertising revenue in Vietnam must comply with the provisions of this Law and other relevant regulations.

For advertising form via SMS, promotional email:

- Organizations and individuals are only allowed to send advertising messages and emails with the prior consent of the recipients;

- Electronic information and telecommunications service providers are only allowed to send messages and emails with advertising content about their services; only send advertising messages to the phone between 07:00 and 22:00; not send more than three promotional messages to a phone number, more than three emails to an email address within 24 hours, unless otherwise agreed by the recipient;

- Organizations and individuals that advertise must ensure that recipients can refuse to advertise; must immediately terminate the sending of advertising messages or e-mails if the recipient notices to reject the advertisement and must not collect a service fee for the recipient's refusal notice.

ADK & Co Vietnam Lawyers Law Firm